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, 35-43

Correspondences: Munvar Miya Shaik

E-mail: munvar.shaik@gmail.com

Introduction

The wisdom tooth (or third molar) is usually the

last tooth to erupt into the mouth anytime after about

16 years of age. Frequently, there is not enough room

Comparative study of tramadol and ketorolac in the pain management of third
molar tooth extraction

M.M. Shaik1, J. Kumar2, S. Mobina3, N. Satyanarayana4, P. Sunitha5

1Lecturer in pharmacology, 2Assistant Professor in Pharmacology, 4Lecturer in Anatomy, 5Lecturer in Physiology, College of

Medical Sciences, Bharatpur, Nepal

3Junior Resident, St Joseph’s Dental College, Eluru, Andhra Pradesh, India

Abstract

Objective: Clinical comparison of efficacy, duration of action, onset of action, side effects of two most

commonly used analgesics tramadol and ketorolac after the third molar tooth extraction.

Materials and methods: The present study was carried out at department of oral surgery, Mamata Dental

Hospital, Khammam, India. 150 patients were randomly selected and divided into two groups. Group A

received 50 mg of tramadol orally and Group B received 10 mg of ketorolac orally. In both groups dose

was repeated for next 24 hrs. Visual scale analog was used for the collection of pain intensity from the

patients.

Results: In Group A, the analgesia started within 1hour and at the end of 24 hours, pain intensity was

2.12 out of 10 on visual analog scale. In Group B, analgesia started within 30 mins and at the end of 24

hours, the pain intensity was 2.98 on visual analog scale. Sedation associated with dizziness and muscle

relaxation was observed with tramadol in 5% of patients and sweating in 8% patients. While in case of

ketorolac, 33% of patients suffered with side effects. Among them 33% patients suffered with bleeding at

the site of tooth extraction and 20% patients suffered with epigastric pain. The analgesic effect of 50 mg

tramadol lasted up to 6 hours and that of ketorolac lasted for 5 hour.

Conclusion: The study shows that tramadol is a suitable and safe analgesic for the relief of post-extraction

pain and is more effective than ketorolac with prolonged analgesia and minimal side effects.

Key Words: Tramadol, ketorolac, third molar tooth extraction,

in the mouth to accommodate the erupting wisdom

teeth and therefore, they might not always come into

the mouth normally. Wisdom teeth are usually either

impacted forwards into the tooth in front or backwards

into the jaw bone. An impacted wisdom tooth causes

infection in the gum surrounding the tooth leading to

Original ArticleJournal of College of Medical Sciences-Nepal, 2010, Vol. 6, No. 1

35



pain and swelling. Sometimes cysts also formed due

to impacted wisdom tooth. To avoid these problems it

is always better to remove the tooth. however, the

management of pain consequent to tooth extraction is

always a major concern for the individual.1, 2

The way pain is experienced is a reflection of the

individual’s emotional, motivational, cognitive, social,

and cultural circumstances. The pain of tooth extraction

is likely to be the most severe pain that an individual

experiences during his or her life.3 Many individuals

rate the pain of tooth extraction as very severe or

intolerable. The pain of tooth extraction varies among

individuals, and each extraction of an individual may

be quite different. Management of post-extraction pain

relieves suffering and leads to earlier mobilization,

shortened hospital stay, reduced hospital costs and

increased patient satisfaction.4,5,6

Tramadol is an atypical centrally-acting analgesic

because of its combined effects as an opioid agonist

and a serotonin and noradrenaline reuptake inhibitor.

The risk of respiratory depression is significantly lower

at equianalgesic doses and does not depress the

hypoxic ventilatory response. It has limited effects on

gastrointestinal motor function. Nausea and vomiting

are the most common side effects and tramadol does

not increase seizure incidence when compared to other

analgesic agents. Tramadol has been used clinically and

evaluated during the past 20 years with broad

indications leading to its widespread use.7

Ketorolac tromethamine is a member of the

pyrrolo-pyrrole group of nonsteroidal anti-

inflammatory drugs (NSAIDs) which was previously

reported for the short term management of moderate

to severe pain. The primary molecular basis for anti-

inflammatory, antipyretic and analgesic effects of

Ketorolac is the inhibition of prostaglandin synthesis

by competitive blocking of the enzyme cyclooxygenase

(COX).

The present study was conducted keeping in view

giving the quicker, prolonged and safer post-extraction

analgesic after third molar tooth extraction for quicker

recovery of the patient from the post-extraction pain.

This study was the clinical comparison of efficacy, safety

and patient satisfaction of clinically widely used

analgesics, tramadol and ketorolac. There were some

reports published the comparing the parenteral

tramadol and ketorolac in maxiofacilary surgery.8,9

Materials and methods

One hundread and fifty patients from routine

admissions with tooth extraction were selected

randomly during the period of 10 months from July

2008 to April 2009 in the department of oral surgery,

Mamata Dental Hospital affiliated to Mamata Dental

College, Khammam, India. The inclusion criteria were:

age in between 18 to 60, undergoing into third molar

tooth extraction, alertness and stability. The exclusion

criteria were: history of drug or substance abuse, allergy

to opioids or any other contraindication for the use of

opioids, end stage renal disease, history of seizure or

any abnormal laboratory tests that could interfere with

our results.

The methodology and procedure of study had

been cleared by the ethical committee and clinical

research review committee, Mamata Dental College.

All the individuals were well informed about the study,

methodology and also about the visual analog scale

prior to tooth extraction. The individuals were

unawared of the analgesic which they had taken during

the study. The drugs ketorolac and tramadol were

Journal of College of Medical Sciences-Nepal, 2010, Vol. 6, No. 1

36



procured from the hospital pharmacy and they have

been assigned a code. Patients were randomly assigned

in either treatment groups with an assigned code.

The patients were divided into two groups

containing 75 patients in each group. All the codes of

administered drugs were disclosed only after the pain

assessment. The group ‘A’ received tramadol 50mg

oral dose before the extraction and dose repeated after

6 hours. The group ‘B’ received ketorolac 10mg oral

dose before the extraction and dose was repeated after

6hrs. Pain assessment was done by verbal rating using

Visual Analog Scale.10, 11 [0 – no pain, 2 - mild pain,

4 - tolerable, 6 – distressful pain, 8 – severe pain

and 10 – totally disabling pain]. The pain

assessment was started after the tooth extraction at

time points of 30 min, 1, 2, 3, 4, 5, 6, 12, 18 and 24

hrs. The patient’s vital signs including heart rate,

respiratory rate and blood pressure were recorded at

every time point after the assessment of pain intensity.

Statistical analyses were performed using Chi-square

test.

Results

The majority of the patients scored an average

pain intensity of ‘8.07’ on visual analog scale as the

maximum pain felt by them in their life time. The

analgesic effect for group ‘A’ who were taken tramadol

started within 1st hour and reached the maximum

analgesic effect in 3 hours. The average rating of pain

intensity is ‘1.12’ on visual analog scale for the

maximum analgesic effect felt at 3rd hour and with the

first dose the analgesic effect sustained for 6 hours.

The analgesic effect of tramadol has been increased

for every six hours and at the end of the 24 hours, the

patients scored the pain intensity of ‘2.12’ on visual

analog scale.

The analgesic effect for group ‘B’ who were taken

ketorolac started within 30 mins and showed its’s

maximum analgesic effect in 1st hour itself. The pain

intensity scored on visual analog is 2.45 at 1st hour.

But the effect was not sustained till the next dose. The

patients felt the pain in the 5th hour itself.  The patients

scored ‘6.94’ in 5th hour and ‘7.34’ in 6th hour on

visual analog scale. After the second dose, the pain

intensity was observed for every 6 hrs. At the end of

24 hours, the patient scored ‘2.98’ on visual analog

scale. The ‘p’ values were less than 0.05 and were

considered statistically significant (Table 1).

According the observations, the analgesic effect

is reached quickly in group ‘B’ who received ketorolac.

However, the duration of analgesia is more in group

‘A’ patients who received tramadol (Figure 1). Many

patients in group who received ketorolac complained

of pain before the dosing schedule time i.e. 6 hours.

The adverse effects in group ‘A’ who took

tramadol were minimum and they were shown only in

8% of the patients. Major adverse effects seen in this

group are sweating (8%), sedation (5%) and decrease

in blood pressure (4%). But in group ‘B’ who were on

ketorolac, adverse effects were observed in 33%

patients. 33% patients reported the bleeding at the

extraction site and 20% patients reported the epigastric

pain. The intensity of adverse effects here increased

as dose increased. With the first dose of ketorolac,

only 8% patients reported both epigastric pain and the

bleeding at the extraction site. (Table 2)

Discussion

Inspite of the spectacular advances in modern

medicine, no single drug satisfied all the criteria of an

ideal post extraction analgesic. Post extraction

analgesia can increase the patients comfort, decrease

M M Shaik et al. Comparative study of Tramadol and Ketorolac in the pain management of third molar tooth extraction

37



the pain and stress after tooth extraction. The present

study was designed to assess and compare the efficacy,

safety and the patient satisfaction of two most

commonly clinically used analgesics tramadol and

ketorolac. Tramadol is a newer opioid with better

analgesic action without the risk of developement of

tolerance and physical dependence. Now it has been

using very commonly for chronic pain. From the

literature it has been considered as safest postoperative

analgesic. 5, 12 Ketorolac is a most commonly used

NSAID for the short term management of pain. Main

focus was on the study of pain intensity and the adverse

effects of both the commonly used analgesics, tramadol

and ketorolac. Safety of therapy was based on the

frequency of side effects and evolution of vital signs

recorded during the study. From the current study it

has been proved that both the drugs are giving better

analgesic effect. Ketorolac is showing its analgesic

effect very rapidly but the action sustained only up to

4 hours (Figure 1). Where as tramadol’s analgesic

effect started after 1 hour and sustained for the longer

time i.e. more than 6 hours (Figure 1). The patients

who received ketorolac also reported severe adverse

effects like epigastric pain, bleeding at the tooth

extraction site, nausea and sweating. Tramadol had a

bit marked effect on blood pressure and also caused

sweating in few patients (Figure 2(a), 2(b), 2(c), 2(d).

Conclusion

The overall study profile proved that tramadol is a

suitable and safe analgesic with longer duration of

action and less adverse effects for relief of post-

extraction pain after third molar extraction and is more

effective than ketorolac with a long sustained analgesic

action. The percentage of side effects was minimal.

References

1. Oladimeji A Akadiri, Ambrose E Obiechina.:

Assessment of difficulty in third molar surgery-a

systematic review. Oral Maxillofac Surg. 2009 (Apr);

67 (4):771-4.

2. Capuzzi P  ontebugnoli L M  Vaccaro M A.: Extraction

of impacted third molars. A longitudinal prospective

study on factors that affect postoperative recovery.

Oral Surg Oral Med Oral Pathol. 1994 (Apr).; 77 (4) :

341-3.

3. HUSSAIN AL-KHATEEB Taiseer; ALNAHAR Amir.:

Pain Experience After Simple Tooth Extraction, Journal

of oral and maxillofacial surgery. 2008 (May).; (66),

911-7 

4. De Beer Jde V, Winemaker MJ, Donnelly GA,  et al.:

Efficacy and safety of controlled-release oxycodone

and standard therapies for postoperative pain after

knee or hip replacement. Can J Surg. 2005; 48:277.

5. Recart A, Duchene D, White PF, et al.: Efficacyand safety

of fast-track recovery strategy for patients undergoing

laparoscopic nephrectomy. J Endourol 2005; 19:1165.

6. Watcha MF, Issioui T, Klein KW, et al.: Costs and effect

of rofecoxib, celecoxib, and otolaryngologic surgery.

Anesth Analog.; 2003; 96: 987

7. Pozos-Guillén Ade J, Martínez-Rider R, Aguirre-

Bañuelos P, et al.: Analgesic efficacy of tramadol by

route of administration in a clinical model of pain.

Proc West Pharmacol Soc. 2005; 48: 61-4.

8. Zackova M, Taddei S, Calò P, et al.: Ketorolac vs

tramadol in the treatment of postoperative pain during

maxillofacial surgery. Minerva Anestesiol. 2001

(Sep);67(9):641-6.

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9. Ong KS, Tan JM.:Preoperative intravenous tramadol

versus ketorolac for preventing postoperative pain

after third molar surgery. Int J Oral Maxillofac

Surg. 2004(Apr);33(3):274-8.

10. Melzack R.:The Mc Gill Pain Questionnaire: Major

properties and scoring methods. 1975;277 – 99

11. Seymour RA.:The use of pain scales in assessing the

efficacy of analgesics in post-operative dental pain

Eur J Clin Pharmacol. 1982;23(5):441-4.

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E, Lehman KA.: Tramadol in the management of post-

operative pain: a double-blind, placebo-and active

drug-controlled study. Eur J Ana. 1997;12(6):646-54.

Tramadol Ketorolac Time intervals at which 
Pain intensity is measured 

Mean ± SD Mean ± SD 

Maximum Pain 8.07±0.12 8.07±0.12 

1st Dose 
30 min 6.16±0.34 4.32±0.18 

1 hr 3.75±0.56 2.45±0.48 
2 hr 1.65±0.82 3.09±0.94 
3 hr 1.12±0.34 3.93±0.71 
4 hr 2.89±0.29 5.65±0.41 
5 hr 4.16±0.73 6.94±0.47 
6 hr 5.41±0.48 7.34±0.12 

2nd Dose 
12 hr 3.89±0.72 4.12±0.53 

3rd Dose 
18 hr 3.12±0.41 3.89±0.64 

4th Dose 
24 hr 2.12±0.27 2.98±0.29 

P-Value < 0.05 
 

 Table 1: Comparison of Pain intensities of Tramadol and Penatazocine

M M Shaik et al. Comparative study of Tramadol and Ketorolac in the pain management of third molar tooth extraction

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Figure 1: Graphical representation – Comparison of pain intensities of Tramadol and Ketorolac

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Tramadol Ketorolac 

Adverse Effects 
No of patients 

with side 
effects* 

Percentage 

(% ) 

No of patients 
with side 
effects* 

Percent
age (% ) 

After 1st Dose   
Sedation 2 2.67 0 0.00 
Sweating 2 2.67 1 1.33 

Bleeding at tooth extraction 
site 

0 
0.00 3 4.00 

Nausea 0 0.00 1 1.33 
Diarrhoea 0 0.00 1 1.33 

Epigastric Pain 0 0.00 4 5.33 
Decrease in B.P. 1 1.33 0 0.00 

After 2nd Dose   
Sedation 3 4.00 0 0.00 
Sweating 4 5.33 3 4.00 

Bleeding at tooth extraction site 0 0.00 6 8.00 
Nausea 2 2.67 3 4.00 

Diarrhoea 1 1.33 2 2.67 
Epigastric Pain 1 1.33 6 8.00 
Decrease in B.P. 3 4.00 1 1.33 

3rd Dose   
Sedation 4 5.33 0 0.00 
Sweating 6 8.00 4 5.33 

Bleeding at tooth extraction site 1 1.33 14 18.67 
Nausea 2 2.67 6 8.00 

Diarrhoea 1 1.33 2 2.67 
Epigastric Pain 1 1.33 10 13.33 
Decrease in B.P. 3 4.00 2 2.67 

4th Dose   
Sedation 4 5.33 0 0.00 
Sweating 6 8.00 5 6.67 

Bleeding at tooth extraction site 1 1.33 25 33.33 
Nausea 2 2.67 9 12.00 

Diarrhoea 1 1.33 2 2.67 
Epigastric Pain 1 1.33 15 20.00 
Decrease in B.P. 3 4.00 3 4.00 

P-Value < 0.05 
 

Table 2: Side effects distribution of Tramadol and Pentazocine

* Each group contains total number of 75 patients

M M Shaik et al. Comparative study of Tramadol and Ketorolac in the pain management of third molar tooth extraction

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Figure 2(a): Graphical representation – Comparison of Adverse effects of Tramadol and Ketorolac

after 1st dose

Figure 2(b): Graphical representation – Comparison of Adverse effects of Tramadol and Ketorolac

after 2nd dose

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Figure 2(d): Graphical representation – Comparison of Adverse effects of Tramadol and Ketorolac

after 4th dose

M M Shaik et al. Comparative study of Tramadol and Ketorolac in the pain management of third molar tooth extraction

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