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|Year : 1993 | Volume
| Issue : 2 | Page : 74-6
A multiple dose comparison of ketorolac tromethamine with ibuprofen for analgesic activity.
SM Anaokar, SV Parulekar, UM Thatte, SA Dahanukar
Dept. of Pharmacology, Seth GS Medical College, Bombay, Maharashtra.
S M Anaokar
Dept. of Pharmacology, Seth GS Medical College, Bombay, Maharashtra.
Source of Support: None, Conflict of Interest: None
This study was done to compare a new analgesic ketorolac with ibuprofen in post-operative and post-laparoscopy pain. A total of 40 patients were recruited for the study of which 20 were post-operative and 20 were post-laparoscopy cases. Medication was given over a period of 48 hours after surgery and a pain score based on subjective symptoms was monitored at fixed intervals after each dose. The analgesic efficacy of ketorolac was found to be comparable to that of ibuprofen and the drug was well tolerated in the doses used without any extra medication being required.
Keywords: Adult, Analgesics, Comparative Study, Drug Combinations, Human, Ibuprofen, Ketorolac Tromethamine, Laparoscopy, Middle Age, Pain, diagnosis,drug therapy,Pain Measurement, Pain, Postoperative, diagnosis,drug therapy,Time Factors, Tolmetin, analogs &derivatives,Tromethamine,
|How to cite this article:|
Anaokar S M, Parulekar S V, Thatte U M, Dahanukar S A. A multiple dose comparison of ketorolac tromethamine with ibuprofen for analgesic activity. J Postgrad Med 1993;39:74
|How to cite this URL:|
Anaokar S M, Parulekar S V, Thatte U M, Dahanukar S A. A multiple dose comparison of ketorolac tromethamine with ibuprofen for analgesic activity. J Postgrad Med [serial online] 1993 [cited 2020 Dec 5];39:74. Available from: https://www.jpgmonline.com/text.asp?1993/39/2/74/631
Ketorolac is a non-steroidal agent with potent analgesic and moderate anti-inflammatory activity1. It is administered as the tromethamine salt orally, intramuscularly, intravenously and as a topical ophthalmic solution. Clinical studies indicate single dose efficacy to be greater than that of morphine, pethidine and pentazocine in moderate to severe operative pain with some evidence of a more favourable adverse effect profile than morphine or pethidine2-4. In single dose studies, ketorolac has also compared favourably with aspirin, paracetamol and other non steroidal anti-inflammatory drugs (NSAIDs)5-8. It also has exhibited anti-pyretic activity in rats9. Like other NSAIDs, ketorolac is an inhibitor of prostaglandin synthesis. As it possesses potent analgesic and moderate anti-inflammatory activity, its use has an advantage over using a combination of two drugs with individual antinflammatory and analgesic properties for post-operative analgesia. Also, a single dose comparison with paracetamol has indicated a lower incidence of overall adverse effect with ketorolac6.
Although available in USA it is not yet marketed in India. This study was performed to evaluate the efficacy and tolerability of ketorolac in the Indian population as compared to the sole agent ibuprofen which is the commonly prescribed agent in post-operative and post- laparos copy pain.
Ethics committee permission was obtained prior to initiation of the trial. Forty patients (20 post-operative and 20 post- 1aparoscopy cases, age: 20-45 yrs) were recruited for the trial after taking their written informed consent. The exclusion criteria were liver, renal or cardiac disease and systemic diseases like diabetes or tuberculosis. Pregnant females and lactating mothers were excluded from the trial. Patients having a history of peptic ulcer, gastritis or allergy to NSAIDs were excluded from the study.
Tablets of ketorolac tromethamine: 10 mg and ibuprofen: 400 mg, were used for the study. Drug administration was commenced as soon as the patient was allowed oral feeds following surgery. Prior to commencement of oral feeds, all post-operative patients received injection diclofenac intramuscularly 8hrly while the post- laparoscopy patients did not receive any parenteral analgesic medication. An equal number of patients in each group (i.e. 10 post-operative and 10 post- laparoscopy) received ketorolac and ibuprofen respectively. Both the drugs were administered in doses of 1 tab three times a day at 6-8 hourly intervals for 2 days. An extra dose or supplementary analgesic therapy was allowed on demand by the patient if relief of pain did not occur. A record of the number of extra analgesics required was kept. A pain intensity score was recorded at fixed time intervals as follows: 1. before starting ketorolac/ibuprofen, 2. 2 hrs after 1st dose, 3. Just before 2nd dose, 4. 2hrs after 2nd dose, 5. 2 hrs after 3rd dose, 6. just before 4th dose(2nd day) 7. 2 hrs after 4th dose, 8. just before 5th dose, 9. 2 hrs after 5th dose and 10. 2 hrs after 6th dose. This was done on a visual analogue scale which ranged from 0=no pain to 10=unbearable pain. Any adverse reactions were noted at each recording. The pain intensity scores of ketorolac and ibuprofen were compared by applying the "Mann-Whitney U Test".
The pain intensity score (mean + S.D) as measured on the visual analogue scale at different time points are shown in [Table:1A] and [Table:1B] and [Figure:1] and [Figure:2] for post-operative and post- laparoscopy cases respectively. The analgesia induced by ketorolac 2 hrs after the first dose and 48 hrs later (i.e after 6 doses) was statistically significant (p < 0.001) in both groups. A similar significant reduction was obtained following ibuprofen (p< 0.001) at both time points and in both groups. In the post- operative group pain relief by ketorolac was found to be significantly better than that by ibuprofen 2 hours after the 1st dose, just before the 2nd dose and 2 hrs after the 2nd dose. [Figure:1] and [Figure:2]. In the post-laparoscopy group, ketorolac was significantly better than ibuprofen just before the 2nd dose, 2 hrs after the 2nd dose and 24 hrs after initiation of drug therapy [Figure:2]. No adverse drug reactions attributed to the drug were noted in both groups. No extra ketorolac tablets or alternate medication were required.
In any study to evaluate an analgesic, it is important to compare the test drug with an accepted standard agent. This has been accomplished in our study. Ketorolac has been compared with ibuprofen, which is commonly used for post-operative analgesia in our hospital. From our results as shown in [Figure:1] and [Figure:2] it is evident that the level of post-operative and post- laparoscopic pain perceived by patients was consistently reduced on multi-dose oral therapy with ketorolac tromethamine (10mg) over a period of 48 hrs. This decrease in pain was comparable with and at times even significantly greater than that observed after therapy with ibuprofen over a similar time period. An important point to note is that the pain scores of the patients in all groups were similar at the time of inclusion prior to drug administration.
The significantly better analgesia provided by ketorolac could be attributed to the fact that its peak levels in the blood are achieved faster and that it has a longer termination half life than ibuprofen1.
Also, ketorolac was well tolerated, and none of the patients needed increased dosage nor additional analgesica. This study corroborates other reports which have compared ketorolac with other analgesics6 including paracetamol, paracetamol + codeine10, aspirin5, 8, 11, aspirin + codeine5, 8, diflusinal12 and gglafenine13.
Thus our study demonstrates that ketorolac is safe and effective in Indian patients and its efficacy is comparable to that of ibuprofen for post-operative analgesia.
We gratefully acknowledge the help given by Dr. Bhavna Doshi and Cadila Laboratory (Ahmedabad) for the study.
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|10.||Vangen O, Doessland S, Lindback E. Comparative study of ketorolac and paracetamol/codeine in alleviating pain following gynaecological surgery. J Int Med Res 1988; 16:443-451. |
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|13.||Arsac M, Frilex C. Comparative analgesic efficacy and tolerability of ketorolac: tromethamine and glafenine in patients with post-operative pain. Current Med Res Opinion 1988; 11:214-220.
[Table - 1], [Table - 2]
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