Article

Effectiveness and Safety of Intravenous Sedation with Propofol

in Non-Operating Room Anesthesia (NORA) for Dental
Treatment in Uncooperative Paediatric Patients
Gianmaria Fabrizio Ferrazzano 1,2,*, Tiziana Cantile 1,3, Martina Quaraniello 1, Michele Iannuzzi 4,
Daniela Palumbo 5, Giuseppe Servillo 5, Silvia Caruso 6, Fabiana Fiasca 6 and Aniello Ingenito 1

1 Department of Neuroscience, Reproductive and Oral Science, School of Paediatric Dentistry, University of
Naples ‘Federico II’, 80131 Naples, Italy; tizianacantile@yahoo.it (T.C.); martina.quaraniello@libero.it (M.Q.);
ingenito@unina.it (A.I.)
2 Unesco Chair in Health Education and Sustainable Development, Paediatric Dentistry Section, University of

Naples ‘Federico II’, 80131 Naples, Italy

3 Department of Medicine, Surgery and Dentistry, Scuola Medica Salernitana, 84081 Baronissi, Salerno, Italy

4 Department of Anesthesiology and Intensive Care Medicine, National Hospital of Sea, 80137 Naples, Italy;

michele.iannuzzi74@gmail.com
5 Department of Neuroscience, Reproductive and Oral Science, School of Anaesthesiology and Intensive Care

Medicine, University of Naples ‘Federico II’, 80131 Naples, Italy; danielapalumbo00@gmail.com (D.P.);
giuseppe.servillo@unina.it (G.S.)
6 Department of Health, Life and Environmental Science, University of L’Aquila, 67100 L’Aquila, Italy;

Citation: Ferrazzano, G.F.; Cantile, silvia.caruso21@gmail.com (S.C.); fabiana.fiasca@alice.it (F.F.)

T.; Quaraniello, M.; Iannuzzi, M.; Pa- * Correspondence: gianmariafabrizio@yahoo.it
lumbo, D.; Servillo, G.; Caruso, S.;
Fiasca, F.; Ingenito, A. Effectiveness Abstract: Background: Uncooperative children require sedative approach for dental treatment. The
and Safety of Intravenous Sedation aim was to assess the effectiveness of Propofol in “Non-Operating Room Anesthesia” (NORA) for
with Propofol in Non-Operating paediatric dental treatment; intraoperative side effects; postoperative side effects; post-discharge
Room Anesthesia (NORA) for Den- effects. Methods: a prospective study, involving 109 uncooperative children undergoing sedation
tal Treatment in Uncooperative Pae-
in NORA using Propofol for dental treatment, was performed. Working sessions, success/failure,
diatric Patients. Children 2021, 8, 648.
intraoperative and postoperative side effects, number of treatment; type of procedure were
https://doi.org/10.3390/
assessed. Parents completed a post-discharge questionnaire on: pain; crying; fever; vomiting;
children8080648
headache; drowsiness; excitability; irritability; ability to eat; drugs and medical care needing.
Academic Editor: Diana Ram Results: Success: 96.7%. Intraoperative side effects: 33.3%. Postoperative side effects: 6.4%.
Statistically significant association between: intraoperative side effects and age (p = 0.001), health
Received: 6 June 2021 status (p = 0.0007), weight (p = 0.038), respectively; intraoperative side effects and number/ type of
Accepted: 13 July 2021 dental treatment (p = 0.0055) and scaling (p = 0.0001), respectively. For post-discharge
Published: 28 July 2021 questionnaires, statistically significant association between: age and crying (p = 0.0001) and
headache (p = 0.002), respectively; health status and crying (p = 0.015) and drugs needing (p = 0.04),
Publisher’s Note: MDPI stays respectively; weight and crying (p = 0.0004); extraction and pain (p = 0.0001) and crying (p= 0.0073),
neutral with regard to jurisdictional
respectively; scaling and crying (p = 0.04), excitability and irritability (p = 0.03), respectively.
claims in published maps and
Conclusion: Propofol in NORA was effective with minimal side effects.
institutional affiliations.

Keywords: uncooperative children; intravenous sedation; Propofol; NORA; paediatric dentistry;

oral health

Copyright: © 2021 by the authors.

Licensee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and 1. Introduction
conditions of the Creative Commons Uncooperative children behavior makes dental treatment difficult and prejudices the
Attribution (CC BY) license quality of treatment provided; this causes a worsening of oral health with a higher
(http://creativecommons.org/licenses incidence of untreated caries and more caries for uncooperative paediatric patients than
/by/4.0/). their less anxious and more cooperative peers [1,2]. Furthermore, patients with particular

Children 2021, 8, 648. https://doi.org/10.3390/children8080648 www.mdpi.com/journal/children

Children 2021, 8, 648 2 of 11

medical conditions and with extensive dental complications tend to show greater fear and
lack of cooperation, mainly due to physical problems, mental disabilities or behavioral
management problems [3].
Therefore, uncooperative children need various patients’ management strategies to
supply adequate treatment. The initial approach is to use behavioral management
techniques, that are a set of procedures targeted at improving child’s cooperation, in order
to obtain complete acceptance of dental care and, ultimately, decrease the child’s
perception that the dental treatment is frightening [4].
Even though behavioral techniques could be useful to obtain children cooperation,
some paediatric patients do not permit dental treatment and may require sedative
approach [5,6].
Mild sedation (oral sedation with benzodiazepines and inhalation conscious sedation
with nitrous oxide and oxygen) is the most commonly used procedure in uncooperative
patients; however, the use of this sedation is not possible in all patients, especially in
patients with severe psychomotor disabilities, because it requires a minimum of
cooperation [7].
Intravenous (IV) sedation with Propofol in ‘Non-Operating Room Anesthesia’
(NORA) can be a valid alternative to achieve moderate sedation and to carry out dental
treatment in totally uncooperative patients or in patients with special medical conditions
[8]. Even though this anesthetic procedure is generally considered to be less popular in
infants and children because of the challenge to gain vascular access, the availability of
mixture of local anesthetics cream (to be applied before inserting the needle) and Propofol
(hypnotic anesthetic) has renewed interest, especially for paediatric ambulatory surgery
and for diagnostic procedures outside the operating room [9].
In fact, the increasing use of invasive diagnostic and therapeutic treatments,
especially in uncooperative patients, has led to a larger request for anesthesia care in non-
operating room location [10].
The ideal anesthetic technique for NORA dental treatment should allow fast onset
and stable operating condition, while guaranteeing quick recovery of protective reflexes
and of cognitive and psychomotor functions. Propofol is a well-known intravenous
anesthetic for ambulatory procedures for its foreseeable recovery with minimum side
effect profile [9].
Propofol is a γ-aminobutyric acid (GABA) receptor agonist and exerts its hypnotic
action through potentiation of the effects of the inhibitory neurotransmitter GABA [11]. It
binds to the β-subunit of the postsynaptic GABAA receptor, where it causes an inward
directed chloride current that hyperpolarises the postsynaptic membrane and inhibits
neuronal depolarisation. This effect is dose-dependent. At low concentrations, propofol
potentiates GABA-activated inward chloride currents, while at higher concentrations, it
directly activates the channel opening [11].
The pharmacokinetic profile of Propofol is incomparable and contributes to its
advantageous characteristic. After an initial bolus, plasma levels rapidly decrease because
of redistribution of Propofol from the brain into less perfused sites such as muscles and
one of the rapid metabolic clearance occurs through the liver [11]. The recovery from its
clinical effects is rapid, even after prolonged administration. In fact, the plasma Propofol
concentration has to decline by only 10–20% to permit awakening [9].
However, some factors such as age, weight, preexisting medical conditions, medical
therapy and type of surgical treatment could influence the Propofol dosage requirements.
Since considerable inter-patient variability exists in both healthy and disable patients, it is
necessary a careful titration of Propofol to minimise adverse effects, such as hypotension,
while permitting a rapid recovery [9].
Recovery is rapid both after a single bolus and after a continuous infusion, which
allows Propofol to be used to maintain anesthesia during short outpatient procedures [9].
Children 2021, 8, 648 3 of 11

Propofol has many pharmacological advantages when compared to other anesthetic

agents, such as fast onset and offset time, and it can be titrated very accurately both by
hand or by using target-controlled infusion (TCI) technology [12].
Thanks to its different characteristics compared to other sedatives, Propofol results
in more effective sedation, better patient cooperation and quick awakening with a
minimal frequency of side effects. Another advantage is fewer side effects due to its anti-
emetic effect (less postoperative nausea and vomiting) and less emergence delirium. The
mechanism behind the anti-emetic effect is not very well understood, but it has been
demonstrated that propofol interacts with dopaminergic (D2) receptors in the
chemoreceptor trigger zone, inhibits the limbic system, thereby interacting with cortical
reflexes reaching the vomiting centre [13–15]. Disadvantages of propofol use include
hypotension, apnea and airway obstruction [14].
When sedation with benzodiazepines is carried out, the specific antagonist,
flumazenil, is always available for use in emergencies, such as accidental oversedation,
iatrogenic overdose or paradoxical reactions. On the contrary, there is no antagonist for
propofol, so it is essential to perform this sedative procedure in NORA with the presence
of an anesthetist [15].
Furthermore, intravenous sedation with Propofol in NORA can be a useful
alternative to general anesthesia (GA), especially in patient who must undergo short and
non-invasive dental treatment.
In fact, orotracheal intubation, length of the dental treatment and discharge duration
are the main differences between IV and GA procedures [14]. The described complications
of orotracheal intubation comprise of: sore throat, laryngeal edema, hoarseness, nerve
injury, aspiration of oral or gastric contents, superficial laryngeal ulcers and laryngeal
granuloma [16].
When compared to patients treated under sedation, general anesthesia patients often
have a slower recovery of cognitive function, more pain, longer time to home readiness
and lower patient appreciation [17].
Even though some studies show the absence of complications in patients with special
needs treated under GA [3], this is often associated with considerable cost and there is a
disproportional increase in costs associated with dental treatment under general
anesthesia respect to intravenous sedation in NORA [18,19].
Based on these observations, the primary goal of this study was to assess the
effectiveness of intravenous sedation in NORA using Propofol for dental treatment in
uncooperative paediatric patients (both healthy/fearful and disabled patients). The
secondary outcome was related to patient safety, considering side effects.

2. Materials and Methods

This study was approved by the Research Ethics Committee of the “Federico II
University” Faculty of Dentistry, Naples, Italy (PT n° 33/19) and was carried out by the
Department of Neuroscience, Reproductive and Oral Sciences, School of Paediatric
Dentistry, University of Naples “Federico II”, in collaboration with the Section of
Anaesthesia and Intensive care, University of Naples “Federico II”, Naples, Italy.
The study lasted from March 2019 to December 2019.
This prospective study used a convenience sample of uncooperative children which
includes all consecutive patients referred for intravenous sedation in NORA with
Propofol for dental treatment at the Dental Clinic of the University Hospital of Naples
“Federico II”, Naples, Italy.
An 80% power, with a standard error of five per cent, and confidence level of 95 per
cent were considered; to cover non-response, the sample was increased of 10%; therefore,
sample size was estimated at 109 children.
In accordance with the Declaration of Helsinki, a total of 109 uncooperative children
(both healthy/fearful and disabled children) with American Society of Anesthesiologists
status I or II, aged ≥ 4 years, undergoing dental treatment under moderate sedation with
Children 2021, 8, 648 4 of 11

Propofol in NORA, were recruited. For these patients, the inhalation sedation with nitrous
oxide and oxygen procedure and oral midazolam sedation were contraindicated, failed or
cannot be performed.
The exclusion criteria were children aged < 4 years and children with American So-
ciety of Anesthesiologists status III, IV and V [20].
A few days before the treatment, parents were invited to accompany their children
to the Dental Clinic of the University Hospital of Naples “Federico II”, Italy—Paediatric
Dentistry Section—to perform blood test, electrocardiogram (ECG), paediatric, cardiolog-
ical and anesthetic examinations.
As the procedures were carried out in NORA, the dental treatment was performed
in day hospital, so the patient was treated and discharged during the same day.
The aim and the procedures of the study were exposed to parents and paediatric
patients, and they were requested to fill a written consent to participate in the study.
Before the treatment, patients received premedication with 0.5 mg/kg of Midazolam
orally, up to a maximum of 15 mg. In this way, any anxious reaction has been attenuated
or eliminated.
Dental treatment was performed by a paediatric dentist and included scaling with
ultrasonic instruments, conservative therapies and dental extractions. After Propofol in-
fusion, for more invasive procedures, such as dental extractions, loco-regional anesthesia
with mepivacaine with adrenaline 1:100,000 was also provided.
Intravenous sedation in NORA was conducted by skilled staff consisting of paediat-
ric anesthesiologists and nursing who are aware of NORA, increasing security, efficacy
and patient/parent appreciation.
The equipment of NORA includes the presence of a multi-parameter monitor, laryn-
goscope, sphygmomanometer, pulse oximeter, capnometer, defibrillator, anesthesia trol-
ley, a reliable source of oxygen and an adequate source of suction. Furthermore, there is a
surgical washing area, a filter room for access and a post-operative environment for con-
trolling the parameters up to the patient’s discharge (recovery room).
Sedation maintenance was achieved by titrating the infusion of Propofol at the pre-
ferred level of sedation. In addition to the infusion, a bolus of 10–20 mg has been used
when an increase of depth of sedation was indispensable.
Blood pressure, heart rate and arterial oxygen saturation were registered at baseline
and during the dental procedure continuously. Hypotension episode was defined as sys-
tolic blood pressure of <100 mmHg, bradycardia as heart rate of <60 bpm and fluctuation
of saturation as arterial oxygen saturation between 93–95%.
The patients should be drowsy but awaken to the slight nociceptive stimulus.
Intravenous sedation with Propofol lasted a maximum of 30 min in each working
session.
The effectiveness of the sedation was registered at the end of the treatment on a di-
chotomous scale: YES = success: scheduled dental treatment was completed; NO = failure:
scheduled dental treatment was not completed due to ineffectiveness of sedation or the
onset of side effects.
The following data were collected: number of working sessions, success/failure, in-
traoperative and postoperative side effects, number of teeth treated and type of dental
procedure executed. At the discharge, parents were asked to fill in at home a questionnaire
on post-discharge effects during the next 12 h to evaluate: post-operative pain; crying;
fever; vomiting; headache; drowsiness; excitability; irritability; ability to eat; need to ad-
minister drugs at home; need for medical care after sedation.
After dental treatment, paediatric patients were transferred to hospital rooms re-
served for them with televisions and electronic games to ensure awakening and a less
traumatic post-operative course and parents were advised to administer painkillers to
their children in case of need, especially after dental extractions.
All data for each patient were stored in a computer, secured with a password and
then analysed.
Children 2021, 8, 648 5 of 11

Statistical Analysis
A descriptive statistic was used to analyse the characteristics of the study sample.
The discrete and nominal variables were expressed in terms of frequencies and percent-
ages. Sample was stratified for: success/failure, presence or not of intraoperative and post-
operative side effects and post-discharge effects, respectively. Differences were evaluated
and tested using the χ2 or Fisher test (as appropriate) for the qualitative variables, as the
non-normal data distribution (Shapiro–Wilk test). All the tests used were bi-directional
and the level of statistical significance was fixed at 5%. All statistical procedures were
carried out using the Statistical Package for the Social Sciences (SPSS version 21.0 for Win-
dows).

3. Results
109 patients (75 males and 34 females), aged between 4 and 17 years, underwent in-
travenous sedation with Propofol in NORA to perform dental treatment.
The average age is 8.36 ± 3.68. The study population was composed of 37 healthy
patients and 72 disabled patients.
In 95 patients one working session was performed and in 14 patients 2 working ses-
sions were performed (for a total of 123 working sessions). The overall success rate was
96.7% (119 out of 123; 4 working sessions failed).
Most patients needed 1.5–4.5 mg/kg/h of Propofol to achieve the desired level of se-
dation.
Intraoperative side effects occurred in 33.3% of cases and the most frequently re-
ported was fluctuation of saturation (30.1%), followed by bradycardia (1.6%) and reflex-
ogenic stimulus (1.6%).
There is no statistical association between intraoperative side effects and gender.
Statistical analysis shows that, in relation to intraoperative side effects, there is a sta-
tistically significant difference between patients aged 4–7 years and patients aged 8–17 (p
= 0.001; power = 0.724); there is a statistically significant difference between healthy pa-
tients and disabled patients (p = 0.0007; power = 0.865); there is a statistically significant
differences between patients with weight <40kg and patients with weight ≥40 kg (p = 0.038;
power = 0.917) (Table 1).

Table 1. Statistical significance of intraoperative side effects in relation to the characteristics of the
patients.

Number of Intraoperative No Intraoperative Side

Variables p-Value
Working Session Side Effects Effects
Age, n (%)
4–7 years old 64 (52%) 10 (15.6%) 54 (84.4%) 0.001 **
8–17 years old 59 (48%) 31 (52.5%) 28 (47.5%)
Health Status, n
(%)
39 (31.7%) 5 (12.8%) 34 (87.2%) 0.0007 *
Healthy
84 (68.3%) 36 (42.9%) 48 (57.1%)
Disabled
Weight, n (%)
<40 kg 85 (69.1%) 22 (25.9%) 63 (74.1%) 0.038 **
≥40 kg 38 (30.9%) 17 (44.7%) 21 (55.3%)
p-value using χ2 ** or Fisher’s* test.

Postoperative side effects occurred in 7 of the total sessions (6.4%) with agitation on
waking in 4 patients (3.6%) and headache in 3 patients (2.7%).
Statistical analysis shows that there is no statistically significant association between
postoperative side effects and gender, age, health status, weight, respectively.
Children 2021, 8, 648 6 of 11

During the study, 428 procedures were performed: 175 conservative therapies, 214
dental extractions and 39 scaling.
The number of teeth treated on average, in each working session, is 3.28 ± 2.63.
There is no statistically significant association between both intraoperative and post-
operative side effects and the number of teeth on which conservative therapy has been
performed.
There is no statistically significant association between both intraoperative and post-
operative side effects and the number of teeth extracted.
There is a statistically significant association between intraoperative side effects, in
particular fluctuation of saturation, and scaling procedure (p = 0.0001; power=1.000), but
not between postoperative side effects and scaling procedure (Table 2).

Table 2. Statistical significance of intraoperative side effects in relation to dental treatment.

Intraoperative No Intraoperative Side

Variables N p-Value
Side Effects Effects
Scaling, n (%)
Yes 39 (31.7%) 36 (92.3%) 3 (7.7%) 0.0001 *
No 84 (68.3%) 4 (4.8%) 80 (95.2%)
p-value using Fisher’s* test.

In 22.7% of cases (27 working sessions), the treatment was performed on the upper
dental arch; in 12.6% of cases (15 working sessions) on the lower dental arch and in 64.7%
(77 sessions) of the cases on both dental arches. In relation to both intraoperative and post-
operative side effects, there are no statistically significant differences between treatment
performed on the upper dental arch and treatment performed on the lower dental arch.
In relation to the survey filled in by the parents after dental treatment on post-dis-
charge effects, 18.5% of the patients had pain, 21% cried, 10.9% had fever, 1.7% vomited,
13.4% had headaches, 46.2% showed drowsiness, 20.2% showed excitability, 21% showed
irritability, 16.8% failed to eat normally, 18.5% needed to take drugs (painkillers). No pa-
tient had to undergo further medical treatment.
There are no statistically significant differences between males and females in rela-
tion to post-discharge effects.
There is a statistically significant association between post-discharge crying and age
(p = 0.0001; power = 0.591) and between post-discharge headache and age (p = 0.002; power
= 0.120).
There is an association between post-discharge crying and the patient’s health status
(p = 0.015; power = 0.175) and between post-discharge need to take drugs and the patient’s
health status (p = 0.04; power = 0.265).
There is a statistical association between post-discharge crying and weight (p =
0.0004; power = 0.235).
Table 3 summarises the statistical analysis of post-discharge effects and patient’s
characteristics.

Table 3. Statistical analysis of post-discharge effects and patient’s characteristics.

Variables Crying p-Value Headache p-Value Drugs p-Value

Yes No Yes No Yes No
Age, n (%)
4–7 years old 23 (35.9%) 41 (64.1%) 0.0001 * 14 (21.9%) 50 (78.1%) 0.002 *
8–17 years old 2 (3.4%) 57 (96.6%) 2 (3.4%) 57 (96.6%)
Healthy status, n
(%)
13 (33.3%) 26 (66.7%) 1 (2.6%) 38 (97.4%)
Healthy 0.015 ** 0.04 *
12 (14.3%) 72 (85.7%) 12 (14.3%) 72 (85.7%)
Disabled
Children 2021, 8, 648 7 of 11

Weight, n (%)
<40 kg 24 (28.2%) 61 (71.8%) 0.0004 *
≥40 kg 1 (2.6%) 37 (97.4%)
p-value using χ2 ** or Fisher’s* test.
In relation to the type of dental treatment performed there is an association between:
post-discharge pain and dental extraction (p = 0.0001; power = 0.796), between post-dis-
charge crying and dental extraction (p = 0.0073; power = 0.513) and scaling (p = 0.0002;
power = 0.359), respectively; post-discharge excitability and scaling (p = 0.0002; power =
0.183) and post-discharge irritability and scaling (p = 0.0002; power = 0.601).
Table 4 summarises the statistical analysis of the post-discharge effects in relation to
dental procedures performed.
There is no association between post-discharge effects and dental arches treated.

Table 4. Statistical analysis of the post-discharge side effects in relation to dental procedures performed.

Variables Extracted Teeth p-Value Scaling p-Value

Yes No Yes No
Pain, n (%)
Yes 29 (74.4%) 12 (14,3%) 0.0001 **
No 10 (25.6%) 72 (85.7%)
Crying, n (%)
Yes 14 (35.9%) 11 (13.1%) 0.0073 ** 0 20 (23.8%) 0.0002 *
No 25 (64.1%) 73 (86.9%) 39 (100%) 64 (76.2%)
Excitability, n (%)
Yes 0 20 (23.8%) 0.0002 *
No 39 (100%) 64 (76.2%)
Irritability, n (%)
Yes 0 20 (23.8%) 0.0002 *
No 39 (100%) 64 (76.2%)
p-value using χ2 ** or Fisher’s* test.

4. Discussion
Paediatric dentistry has provided several pharmaceutical and non-pharmaceutical
methods for controlling children’s behavior; however, non-pharmaceutical and conscious
sedative methods may not work for extremely uncooperative children. Therefore, for pa-
tients with severe anxiety and for intellectually disabled patients, intravenous sedation is
often required for dental procedures [21].
The possibility of carrying out dental treatment in NORA is a great advantage as it
allows to carry out anesthetic procedures in a different environment from the operating
room. This allows the patient, who has to undergo short and non-invasive dental treat-
ment, to be treated in all phases by highly specialised personnel and to avoid a longer
hospital stay.
Drugs utilised for intravenous sedation in paediatric patients, submitted to dental
treatment in NORA, should display specific properties, comprising fast onset of action
and capability to suppress patient movements during treatments. Furthermore, great re-
covery should be assured, comprising marginal respiratory and circulatory depression,
short time to awakening and reduction of postoperative side effects.
Propofol, which activates inhibitory GABA receptors, ensures fast recovery and it
should be considered appropriate for intravenous sedation in paediatric patients submit-
ted to ambulatory dental treatment [21].
In addition, in paediatric patients, premedication drugs are frequently used to alle-
viate the fear of procedure, to make separation from parents easier and to perform a pleas-
ant induction of intravenous sedation.
Children 2021, 8, 648 8 of 11

In the present study, Midazolam, a short-acting benzodiazepine that produces anxi-

olytic, amnestic, hypnotic, anticonvulsant and skeletal muscle relaxant effects, was used
as premedication agent with good results [22].
In our study, there was a disproportion regarding the gender of the patients (75 males
and 34 females). Some previous studies supported this data distribution, although it is not
clear why the masculine gender often outnumbers the feminine gender [3].
The most reported intraoperative side effects in children undergoing intravenous se-
dation were respiratory problems (5.5–31.7%). We observed similar levels of fluctuation
of saturation (30.1%) with Propofol, but never below than 93% [23].
In particular, during a longer dental treatment a higher dose of Propofol is often re-
quired. This can lead to deeper sedation which could more easily cause respiratory de-
pression. [24].
Another side effect related to the administration of Propofol alone or in combination
with other drugs is bradycardia [23]. In our study, the incidence of bradycardia was 1.6%.
Moreover, intraoperative side effects occurred with a higher frequency in disabled
patients. In fact, hypotension with initial Propofol bolus is a temporary and predictable
event that is more frequent in patients with special medical condition [23]. As these pa-
tients experience stressful situations in a more accentuated way, it is necessary a close
collaboration between dentists and anesthetists to draw up a tailored therapeutic plan.
[25].
In addition, intraoperative side effects occurred in 44.7% of cases in patients with
weight > 40 kg and in 52.4% of cases in patients aged 8–17 years. These patients, in fact,
require higher doses of Propofol to obtain the desired level of sedation with a greater risk
of occurrence of side effects. Chidambaran et al. reported that administration of Propofol
in severely obese adolescents caused an overdose associated with slow awakening, in-
creased postoperative sleepiness and incidence of postoperative respiratory side effects.
[26].
This study also showed statistical association between scaling and intraoperative side
effects, in particular fluctuation of saturation. During intravenous sedation with Propofol,
in fact, the patient is not intubated and retains the protective airway reflexes, so the greater
quantity of water nebulised by the scaler during this procedure can reach the patient’s
airway and cause laryngospasm with subsequent fluctuation of saturation. It is, therefore,
essential to implement a series of strategies to obtain a careful aspiration of the liquids
dispensed by dental instruments through the use of high-speed aspirators used by paedi-
atric dentists highly specialised in the management of the airways. However, a study com-
pared the laryngeal response to rigid laryngoscopy manipulation in children under
sevoflurane anesthesia versus Propofol. The incidence of laryngospasm in the first group
was 26% versus 4% in the Propofol group [27].
Intravenous sedation with Propofol showed a very low percentage (6.4%) of the onset
of postoperative side effects as shown also by studies in the literature [28].
Propofol, in fact, has an antiemetic effect which has reduced the presence of side ef-
fects such as vomiting and nausea. Moreover, Propofol showed a lower frequency of agi-
tation upon awakening (4.8%) than sevoflurane used in general anesthesia (58%) [29].
Uezono et al. demonstrated that in preschool children submitted to a minor procedure,
sevoflurane determines a greater incidence of emergence agitation respect to Propofol
(38% vs. 0%) [30].
Chandler et al. demonstrated a lower incidence of emergency delirium (ED) after in-
travenous sedation with Propofol compared to general anesthesia with sevoflurane in
children aged 2 to 6 years [31]. Furthermore, their results confirmed that intravenous se-
dation with Propofol exhibits better characteristics in terms of awakening, post-treatment
recovery and emergency delirium.
In addition, GA is an expensive procedure performed by trained anesthetists in hos-
pital, and it requires a preoperative time before intervention for both dental practitioners
and caregivers [3].
Children 2021, 8, 648 9 of 11

The first 24 h after dental treatment can be characterised by the onset of side effects.
In this regard, it is essential that parents are informed by the dentist about post-sedation
side effects and their management. [32].
There is an association between post-discharge effects (especially crying, headache,
difficulty to eat and need to take drugs) with the age, health status and weight of the
patients.
In fact, the youngest and disabled patients cried after treatment. This may be related
to an amplified perception of the treatment carried out, in particular after dental extrac-
tions. In fact, in a study carried out by Ozer et al., greater agitation was noted after treat-
ments concerning dental surgery than those concerning restorative procedures [33].
In this regard, rooms were suitable for the awakening of small patients who, follow-
ing treatment, require a reassuring environment. In fact, in the present study, patients
who underwent intravenous sedation with Propofol, after dental treatment, were trans-
ferred to hospital rooms reserved for paediatric patients with televisions and electronic
games to ensure awakening and a less traumatic post-operative course.
There is also an association between dental procedure performed (in particular ex-
traction) and onset of post-discharge effects after treatment (specifically: pain, crying and
the need to take drugs). These post-discharge effects were related to the dental procedure,
rather than to the characteristics of intravenous sedation. In fact, scientific studies confirm
that Propofol provides better post-operative pain relief with a significant reduction in pain
scores by 40% compared to other types of sedation [28].
Our findings should be interpreted in the context of study limitations: first of all, the
impossibility of using the rubber dam. In fact, this can represent an obstacle in emergency
maneuvers if side effects arise. In the event that fluctuation of saturation occurs, the pa-
tient needs oxygen administration and removal of the rubber dam can delay this maneu-
ver. Therefore, in restorative treatment it is very important to use good saliva aspiration
and highly qualified dental assistance in order to complete the treatment in the best pos-
sible way.

5. Conclusions
This study demonstrated that intravenous sedation with Propofol in NORA can be
used successfully when the dental treatment is essential, and the child does not cooperate
during treatment.
Intravenous sedation with propofol allows to safely and effectively carry out dental
procedures in non-cooperative paediatric patients in an outpatient setting by personnel
qualified in the management of any complications. This also provides a financially valu-
able option to general anesthesia for paediatric dental procedures.
However, there are few studies in the literature on the use of intravenous sedation in
NORA with Propofol to carry out dental procedures; so this study could be considered a
starting point to open new scenarios for further studies on the matter.

Author Contributions: Conceptualisation, G.F.F., T.C., M.Q. and A.I.; data curation, D.P. and G.S.;
formal analysis, M.I. and F.F.; investigation, M.I., D.P. and G.S.; methodology, S.C. and F.F.; project
administration, A.I.; resources, G.F.F.; supervision, G.F.F.; validation, T.C.; visualisation, M.Q.; writ-
ing—original draft, T.C. and M.Q.; writing—review and editing, G.F.F., M.I., D.P., G.S., S.C., F.F.
and A.I.. All authors have read and agreed to the published version of the manuscript.
Funding: This research received no external funding
Institutional Review Board Statement: The study was conducted according to the guidelines of the
Declaration of Helsinki and approved by the Ethics Committee of University of Naples “Federico
II” (protocol code 33/19, date of approval: 18/03/2019).
Informed Consent Statement: Informed consent was obtained from all children and their guardians
involved in the study.
Children 2021, 8, 648 10 of 11

Data Availability Statement: The data presented in this study are available on request from the
corresponding author for a reasonable reason.
Conflicts of Interest: The authors declare no conflict of interest.

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