Original Article

Comparative study of analgesia of ketorolac, tramadol,

and flupirtine in the management of third molar surgery
ABSTRACT
Introduction: The most commonly performed surgical procedure in most oral and maxillofacial surgery practices is the removal of third
molars. Postoperative pain is considered a form of acute pain due to surgical trauma with an inflammatory reaction.
Materials and Methods: One hundred and fifty patients were included in the study which were divided into GROUP‑A, B, and C‑50 patients each;
those who underwent third molar removal under local anesthesia. Local anesthesia was obtained by inferior alveolar, lingual, long buccal, posterior
superior alveolar, and greater palatal nerve block injections after first complain of pain, all patients were prescribed analgesics (Ketorolac‑10 mg),
(Tramadol‑50 mg), (Flupirtine‑100 mg), and antibiotics co‑amoxiclav‑625 mg) T. D. S in all the three groups A, B, C, respectively, for 5 days and the
timing noted in the patients assessment sheet. The statistical analysis was done using SPSS Version 15.0 statistical analysis software.
Results: The flupirtine group has early onset and also had minimum side effects. All the groups showed similar trend in change in pain score
from 3 h. P. O to different time intervals. It was observed the pain score increased significantly till 6 h. Post operative a decreased trend was
found at 24 h, 48 h, 78 h, after 6 h. and this change was found to be statistically significant for all three groups.
Conclusion: Flupirtine had faster onset and comparable pain management profile as compared to tramadol, it also had minimum side effects,
hence the use of flupirtine might be recommended for postoperative pain management in cases undergoing third molar surgery.

Keywords: Analgesia, flupirtine, ketorolac, third molar surgery, tramadol

INTRODUCTION tramadol, and flupirtine in management of third molar

surgery as per the following parameter:
The most commonly performed surgical procedure in most 1. Onset of analgesia
oral surgery practices is the removal of third molars. 2. To compare the efficacy of analgesia postoperatively
3. Duration of analgesia after 1st dose of drug given
The pain of tooth extraction varies among individuals, and 4. To compare adverse effect.
each extraction of an individual may be quite different.[1,2] Ashutosh Kumar Gupta, Munish Kohli,
Praveen Kumar Pandey, Pankaj Dayal Dwivedi,
Pain associated with removal of third molars usually occurs Vaibhav Pratap Singh
in between moderate to severe in the first 24 h after surgery, Department of Oral and Maxillofacial Surgery, Chandra Dental
with pain peaking between 6 and 8 h.[3] The problem of dental College, Barabanki, Uttar Pradesh, India
pain can be tackled using peripherally acting or centrally Address for correspondence: Dr. Ashutosh Kumar Gupta,
acting drugs. Here, the effect of ketorolac, tramadol, and 300, Eldeco Udyan 2, Raksha Khand, Opposite OP Chowdhary
Hospital, Raebarely Road, Lucknow ‑ 226 014, Uttar Pradesh,
flupirtine in the management of pain after third molar
India.
extraction is considered. E‑mail: drashutoshdkmc@gmail.com

Received: 29 November 2020, Revised: 24 December 2020,

Aim and objective Accepted: 06 May 2021, Published: 15 June 2022
Comparing analgesic efficacy of orally administered ketorolac,
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How to cite this article: Gupta AK, Kohli M, Pandey PK, Dwivedi PD,
DOI:
Singh VP. Comparative study of analgesia of ketorolac, tramadol, and
10.4103/njms.NJMS_261_20 flupirtine in the management of third molar surgery. Natl J Maxillofac Surg
2022;13:262-8.

262 © 2022 National Journal of Maxillofacial Surgery | Published by Wolters Kluwer - Medknow
 Gupta, et al.: Comparative study of analgesia

MATERIALS AND METHODS Table 1: Distribution of study population

Group Analgesic Number of case (%)
A prospective study was conducted in the Department of Group‑1 Tablet ketorolac 10 mg 50 (33.33)
Oral and Maxillofacial Surgery, Chandra Dental College and Group‑2 Tablet tramadol 50 mg 50 (33.33)
Hospital, Barabanki. Ethical clearance obtained from Ethical Group‑3 Capsule flupirtine 100 mg 50 (33.30)
Committee of Chandra Dental College and Hospital, Safedabad,
Barabanki, Uttar Pradesh, India, reference no: Cdch/os/12- groups (F = 0.987, P = 0.315, NS). Age‑wise groups were
15/01, dated:10/02//14. In this study, 150 patients, divided into similar as shown in Table 2.
groups A, B, and C– fifty patients each those who underwent
third molar removal under local anesthesia were included in Male population was higher than the female population. Male
the study. Sample size was calculated by characteristic visual was 62% in Group‑I and III and 58% in Group‑II and female
analog scale (VAS) of superior group and inferior group. was 38% in Group‑I and Group‑III and 42% in Group‑II. On
Randomization was done by systematic sampling technique comparison, there was no significant difference in gender of
as shown in Table 1. the three groups (P = 0.894, NS) Three groups were similar
sex wise as shown in Table 3.
Patient inclusion criteria
All cases included were ASA Grade‑l healthy patients in the Out of 150 patients enrolled in the study, site of tooth involved
20–50 years age group with unilateral or bilateral third molar in maxillary jaw was one third of total patients (n = 50,33.33%),
irrespective of their angulations and were free from any and in mandibular jaw was two third of total patients
inflammatory symptoms including hyperemia, pericoronitis, (n=100,66.67%). There was a significant difference in the site of
swelling, and trismus at the time of the procedure. the tooth in the three groups (P = 0.81, NS) as shown in Table 4.
• Mean ± SD of onset of Group‑I was 40.50 ± 6.94
Patient exclusion criteria • Mean ± SD of onset of Group‑II was 44.00 ± 5.05
Cases with a known histor y of systemic disorder, • Mean ± SD of onset of Group‑III was 41.50 ± 6.00
immunocompromised patient, and patient suffering from mental • On comparison by ANOVA P = 0.013 (Sig).
illness were excluded from the study. Patients with a history of
sensitivity to ketorolac, tramadol, and flupirtine was excluded There is significant difference in the time of onset of analgesia
from the study, and patients requiring incision and bone cutting in the respective three groups. On patients of HOC test
for tooth removal were also excluded from the study. (Tukey) Group‑I versus Group‑II P = 0.12 (Sig) onset. There
was less in Group‑I than Group‑II and significant.
Material used
Basic instruments required for extraction: Group‑I versus Group‑III P = 0.68 (NS). Time of onset is less in
• Tablet Ketorolac 10 mg Group‑I than Group‑III but non significant. Group‑II versus Group‑III
• Tablet Tramadol 50 mg P = 0.10 (NS). Time of onset is more in Group‑II than Group‑III.
• Cap. flupirtine 100 mg Time of onset is least in Group‑I and maximum in Group‑II.
• Visual analog scale • Mean ± SD of duration of analgesia in Group‑I was
• Postoperative pain. 6.40 ± 0.49 h
• Mean ± SD of duration of analgesia in Group‑II was
Operative technique 6.70 ± 0.46 h
A standardized surgical approach to the removal of the • Mean ± SD of duration of analgesia in Group‑III was
third molars was followed, Local anesthesia was obtained 6.80 ± 0.61 h
by inferior alveolar, lingual, long buccal, posterior superior • On comparison by ANOVA the P = 0.001 which is
alveolar, and greater palatal nerve block injections using statistically significant as shown in Table 5.
2% lignocaine with 1:80,000 adrenaline.
Intergroup pair wise comparison between duration of analgesia,
RESULTS after first dose by tukey test method as shown in Table 6.

The mean ± standard deviation (SD) age of Group‑I was I versus II duration of analgesia is significantly more in
38.75 ± 9.25 ranged (20–50). The mean ± SD age of Group‑II Group‑II than Group‑I P = 0.013.
was 38.50 ± 8.25 ranged (20–50). The mean ± SD age
Group‑III was 38.48 ± 8.77 ranged (21–50). We found there I versus III duration of analgesia is significantly more in
was no statistically significant difference in age of the three Group‑III than Group‑I P = 0.001.
National Journal of Maxillofacial Surgery / Volume 13 / Issue 2 / May-August 2022 263
 Gupta, et al.: Comparative study of analgesia

Table 2: Intergroup comparison of age of study population

Group Number of cases Minimum Maximum Median Mean±SD ANOVA
Group‑1 50 20 50 40.0 38.76±9.25 F=0.987
Group‑2 50 20 50 38.5 38.50±8.25 P=0.315
NS
Group‑3 50 21 50 36.00 38.48±8.77
SD: Standard deviation, NS: Not significant

Table 3: Intergroup comparison of gender of study population

Gender Group‑I, n (%) Group‑II, n (%) Group‑III, n (%) χ2, df P
Female (n=59) 19 (38.0) 21 (42.0) 19 (36) 0.224, 0.894
Male (n=91) 31 (62.0) 39 (58.0) 31 (62.0) 2

Table 4: Intergroup comparison of site of tooth involved

Site of tooth Group‑I, n (%) Group‑II, n (%) Group‑III, n (%) χ2, df P
Maxillary (n=50) 18 (36.0) 15 (30) 17 (34) 0.420, 0.81 (NS)
Mandibular (n=100) 32 (64.00) 35 (70) 33 (66.0) 2
NS: Not significant

Table 5: Intergroup comparison of time of onset of analgesia (min) of study population

Group Number of cases Minimum Maximum Median Mean±SD ANOVA Group‑wise comparison
Group‑1 50 30 45 45.0 40.50±6.94 F=0.44 I versus II P=0.012
Group‑2 50 40 55 40.0 44.00±5.05 P=0.013 I versus III P=0.687
Significant
Group‑3 50 30 50 45.0 41.50±6.00 II versus III P=0.100
SD: Standard deviation

Table 6: Intergroup comparison of duration of analgesia (h) after first dose of study population
Group Number of cases Minimum Maximum Median Mean±SD ANOVA Group‑wise comparison (by Tukey test)
Group‑1 50 6 7 6 6.40±0.49 F=7.86 I versus II P=0.013
Group‑2 50 6 7 7 6.70±0.46 P=0.001 I versus III P=0.001
Gruop‑3 50 6 8 7 0.61±0.61 II versus III P=0.608
SD: Standard deviation

II versus III duration of analgesia is more in the Group‑III than AT 24 h.

Group II P = 0.608 (NS) • Group‑I versus Group‑II: No significant difference in pain
score among in groups
Duration of analgesia is maximum in Group III than in Group‑II • Group‑I versus Group‑III: No significant difference in pain
and least in Group‑I. score among groups
• Group‑II versus Group‑III: No significant difference in
AT 3 h: pain score among groups.
• Group‑I versus Group‑II: No. significant difference in pain
score P = 0.25 AT 48 h:
• Group‑I versus Group‑II: Pain significantly more in Group‑I • Group‑I versus Group‑II: Pain is significantly more in
than Group.‑III P = 0.013 Group‑I than Group‑II, P = 0.042
• Group‑II versus Group‑III: No significant difference in • Group‑I versus Group‑III: No significantly difference in
pain score P = 0.16. Group‑I and Group‑III, P = 1
• Group‑II versus Group‑III: Pain is significantly more in
AT 6 h: Group‑III than Group‑II, P = 0.042.
• Group‑I versus Group‑II: Pain is significantly more in
Group‑I than Group‑II P = 0.025 AT 72 h.
• Group‑I versus Group‑III: Pain is significantly more in • Group‑I versus Group‑II: No significant difference in pain
Group‑I than Group ‑III P = 0.002 score among groups
• Group‑II V. Group‑III No significantly difference in pain • Group‑I versus Group‑III: No significant difference in pain
score in Group‑II and Group‑III P = 0.25. score among groups
264 National Journal of Maxillofacial Surgery / Volume 13 / Issue 2 / May-August 2022
 Gupta, et al.: Comparative study of analgesia

• Group‑II versus Group‑III: No significant difference in (44.00 ± 5.05 min). Delayed onset of tramadol (50 mg) as
pain score among groups as shown in Table 7a and b. compared to ketorolac (10 mg) at same dosages has also
been reported by Shaik et al.[4] There is no study available
All the groups showed a similar trend in change of pain evaluating the use of flupirtine (100 mg) as compared to oral
score from 3 h postoperative to different time intervals. tramadol (50 mg) or ketorlac (10 mg) for postoperative pain
It was found that a statistically significant increase in pain among patients undergoing third molar surgery and hence,
score was observed at 6 h postoperative and thereafter at it is difficult to comment on the pharmacological differences
24 h p. o., 48 h p. o., and 72 h p. o. a subsequent decrease resulting in the early onset of flupirtine as compared to
with time from that at 3 h was observed and this change was tramadol.
found to be statistically significant in all the three groups as
shown in Table 8. The faster action of flupirtine as compared to tramadol could
be attributed to its dual therapeutic effect with both analgesic
Proportion of patients with side effects after first dose and muscle relaxant properties that has utility in the treatment
was found to be lower in Group I and Group III (8.00%) as of pain, including that associated with muscle tension.[5]
compared to Group II (14.00%), but this difference was not
found to be statistically significant. In the present study, tramadol and flupirtine groups had a
relatively longer analgesic effect as compared to ketorolac
Proportion of patients with side effects after the second for the first dose of the drug. This might be attributed to
dose was found to be higher in Group II (26.00%) followed a shorter half‑life and smaller dose of ketorolac (10 mg) as
by Group I (20.0%) and lowest in Group III (12.0%). compared to the other two drugs.

Proportion of patients with side effects after the third dose In the present study, 3 h postoperative pain scores were
was found to be higher in Group II (30.00%) followed by found to be significantly lower in the flupirtine group as
Group I (20.0%) and lowest in Group III (16.0%) as shown in compared to ketorolac whereas no significant difference
Table 9. between tramadol and ketorolac and tramadol and flupirtine
was observed at this time interval. For evaluation up to
DISCUSSION 72 h, throughout no significant difference between tramadol
and flupirtine group was observed except at 48 h when
The present study is the first study comparing the efficacy pain scores in tramadol group were significantly lower as
of flupirtine (100 mg) administered postoperatively compared to both flupirtine and ketorolac groups. Ketorolac
t h ro u g h o r a l ro u t e w i t h t r a m a d o l ( 5 0 m g ) a n d showed significantly higher pain scores as compared to both
ketorolac (10 mg) administered through similar route flupirtine and tramadol at 6 h postoperative interval too.
following same dosage schedule, the results showed its Thus, tramadol and flupirtine outperformed ketorolac at
comparability on pain intensity and a better control on several occasions, whereas tramadol and flupirtine showed
the side effects. In the present study, the proportion of comparable results for most of the postoperative periods.
males was higher as compared to females (1.5:1 however,
as the three groups were matched for gender, hence In all the three groups, between 3 and 6 h postoperative
these confounding effects, if any were evenly distributed intervals an increase in mean pain scores was observed,
among the groups. however, in subsequent intervals with the passage of time a
significant reduction in pain scores was observed in all the
In the present study, the onset time for analgesia ranged from three groups.
30 to 55 min. Mean onset time was comparable for ketorolac
(40.50 ± 6.94 min) and flupirtine (41.50 ± 6.00 min) Although statistically significant differences in pain scores
groups and was significantly higher for the tramadol group of three groups were observed, however, clinically, pain

Table 7a: Intergroup comparison of postadministration of drug (after first reporting of pain) visual analog scale score at different
time intervals (KruskalWallis H‑test)
Duration/VAS 3h 6h 24 h 48 h 72 h
Group‑1 (mean±SD) 3.30±0.46 4.50±0.68 2.10±0.30 2.0±00 1.58±1.11
Group‑2 (mean±SD) 3.2±0.40 4.30±0.46 2.06±0.24 1.92±0.27 1.48±1.22
Group‑3 (mean±SD) 3.10±0.30 4.20±0.40 2.10±0.30 2.0±0.0 1.42±1.18
VAS: Visual analog scale, SD: Standard deviation

National Journal of Maxillofacial Surgery / Volume 13 / Issue 2 / May-August 2022 265

 Gupta, et al.: Comparative study of analgesia

scores were of mild‑to‑moderate category during first 6 h patients had pain scores of mild order only. Mean pain scores
(scores 3‑5) and thereafter in mild category (scores <3) at were <2 at this time interval.
24 and 48 h intervals. At 72 h, though some patients had
pain scores as high as 5 and 6 yet in general most of the In general, all the three groups showed almost equivalent
analgesic activity and control of pain clinically notwithstanding
Table 7b: Comparison between groups for postadministration of the statistically significant differences in pain scores.
drug (after first reporting of pain) visual analog scale score at
different time intervals (MannWhitney U‑test)
However, as far as statistically significant differences in pain
Group‑I Group‑I Group‑II scores are concerned, in the present study, tramadol showed a
versus versus versus
Group‑II Group‑III Group‑III better control as compared to ketorolac. In a study comparing
Z P Z P Z P the preemptive use of intravenous (IV) tramadol with IV
3 h postoperative 1.149 0.25 2.48 0.013 1.39 0.16 ketorolac, Ong and Tan[6] reported a better postoperative pain
6 h postoperative 2.23 0.025 3.14 0.002 1.149 0.25 control in third molar surgery cases for cases receiving ketorolac.
24 h postoperative 0.74 0.46 0.0 1.0 0.73 0.46
48 h postoperative 2.03 0.042 0.0 1.0 2.03 0.542 Mishra et al. in their study comparing preoperative and
72 h postoperative 1.57 0.11 1.86 0.062 0.25 0.79 postoperative use of oral dose of ketorolac (20 mg) with

Table 8: Intragroup change in pain score from 3 h of postadministration of drug (after first reporting of pain) (Wilcoxon signed‑rank
test)
Group I Group II Group III
Mean±SD Z P Mean±SD Z P Mean±SD Z P
6h 1.200±0.990 5.421 <0.001 1.10±0.30 6.784 <0.001 1.10±0.30 6.784 <0.001
24 h −1.200±0.404 6.583 <0.001 −1.14±0.50 6.364 <0.001 −1.00±0.14 7.071 <0.001
48 h −1.300±0.463 6.450 <0.001 −1.28±0.45 6.472 <0.001 −1.10±0.30 6.784 <0.001
72 h −1.720±1.126 5.730 <0.001 −1.72±1.29 5.476 <0.001 −1.69±1.25 5.329 <0.001
SD: Standard deviation

Table 9: Intergroup comparison of side effects at different doses

Side effects Group I (n=50), n (%) Group II (n=50), n (%) Group III (n=50), n (%) Statistical significance
χ2 P
At 1st dose
No complication 46 (92.0) 43 (86.0) 46 (92.0) 12.433 0.257
Diarrhea 1 (2.0) 0 0
Hypotension 0 1 (2.0) 0
Nausea 2 (4.0) 0 2 (4.0)
Sedation 0 3 (6.0) 2 (4.0)
Sweating 1 (2.0) 3 (6.0) 0
At 2nd dose
No complication 40 (80.0) 37 (74.0) 44 (88.0) 15.862 0.322
Diarrhea 2 (4.0) 0 1 (2.0)
Hypotension 2 (4.0) 2 (4.0) 0
Nausea 3 (6.0) 3 (6.0) 2 (4.0)
Sedation 0 3 (6.0) 3 (6.0)
Sedation+hypotension 0 1 (2.0) 0
Sweating 2 (4.0) 4 (8.0) 0
Sweating+nausea 1 (2.0) 0 0
At 3rd dose
No complication 40 (80.0) 35 (70.0) 42 (84.0) 31.017 0.006
Constipation 0 1 (2.0) 0
Diarrhea+hypotension 3 (6.0) 0 0
Hypotension 0 4 (8.0) 0
Nausea 4 (8.0) 1 (2.0) 4 (8.0)
Sedation 0 5 (10.0) 3 (6.0)
Sweating 3 (6.0) 1 (2.0) 1 (2.0)
Sweating+nausea 0 3 (6.0) 0

266 National Journal of Maxillofacial Surgery / Volume 13 / Issue 2 / May-August 2022

 Gupta, et al.: Comparative study of analgesia

tramadol (50 mg) showed statistically no significant compared to tramadol at the given dosage (10 mg), it was
difference between two drugs for both preoperative and less effective in pain management as compared to the
postoperative administration for control of postoperative other two regimens.
pain up to 6 h postoperative interval. However, in the
present study ketorolac (10 mg) at 6 h had significantly Both flupirtine and ketorolac had a faster onset and better
higher pain score as compared to tramadol (50 mg) at 6 h side effect profile as compared to tramadol. A few studies
interval, thus indicating that the dosage of ketorolac (10 mg) have reported depression to be a side effect of flupirtine,[8,13]
used in the present study was not optimized and needs an however, in the present study no such side effect was
increment in order to achieve a comparable pain control noted. Given the limited number of clinical trials evaluating
as for tramadol. and comparing the efficacy of three analgesic regimens
as used in the present study, we would recommend more
Similar to our study, where tramadol (50 mg) and flupirtine studies on the issue before making any recommendations
(100 mg) were found to be comparable for postoperative for clinical practice.
pain management at a similar regimen (postoperative,
5 days × tds), Naser et al.[7] a similar efficacy of two drugs CONCLUSION
throughout the period of evaluation. In another study,
Moore et al.[8] while comparing flutirpine (100 mg) against The findings in the present study showed that flupirtine
another opioid (dihydrocodeine 60 mg) through oral had a faster onset and comparable pain management
route found similar efficacy of two in postoperative pain profile as compared to tramadol and ketorolac, it also had
attenuation. minimum side effects, hence the use of flupirtine might be
recommended for postoperative pain management in cases
The findings in the present study thus underline that the undergoing third molar surgery.
three drugs used for comparison of postoperative pain
Financial support and sponsorship
management had a similar profile, however, indicating
Nil.
the need of upgradation and optimization of ketorolac
dosage to obtain a comparable performance. These
Conflicts of interest
findings are in accordance with the findings in the
There are no conflicts of interest.
literature, as shown above, however, the onset of action
and long‑term efficacy of the drugs was dependent on the
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