Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management

Study Overview
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Brief Summary
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Compare between the analgesic efficacy of diclofenac sodium and ketorolac tromethamine in post-tonsillectomy pain management.and Compare between the effect of diclofenac sodium and ketorolac tromethamine on post-tonsillectomy bleeding

Detailed Description
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patients will be randomly allocated to two groups of 50 patients each Group (A): will receive intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously. Group (B): will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg intravenously. Then the two groups will continue postoperatively on the same drug received intra-operative I. Intra-operative data: Bleeding score will be assessed by the surgeon at the end of the operation using the following Scale for bleeding assessment (0 = no bleeding, 1 = bleeding as usual, 2 = bleeding more than usual, 3 = profuse, 4 = excessive, and lastly 5 = excessive and continuous). II. Early Post-operative data: Post- tonsillectomy bleeding assessments; Bleeding score will be recorded immediately postoperative and 3, 6, 12 and 24h postoperatively. Hospital re-admission because of bleeding. Re-operation because of bleeding. Post- tonsillectomy pain assessments; Pain intensity will be assessed postoperatively by the verbal rating scale (VRS; 0 = no pain, 1 = mild pain, 2 = moderate pain, 3= severe pain, and lastly 4= excruciating pain). VRS assessment will be performed immediately postoperative and 3, 6, 12 and 24h postoperatively. Analgesia will be given if requested or if the VRS≥3. Patients in Group A will receive diclofenac sodium 0.3 mg/kg iv, while patients in Group B will receive ketorolac tromethamine 0.5 mg/kg. The total consumption of analgesics used in each group in the first 24 h postoperative will be calculated and the time of the first request for analgesia will be recorded. - Time needed to restore normal dietary habits. IV. Late Post-operative data: As aweekly follow up for 2 weeks : bleeding tendency Dysphagia. Time needed to restore normal dietary habits

Official Title
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Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management

Conditions
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Pain, Acute

Intervention / Treatment
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* Drug: diclofenac
* Drug: ketorolac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children scheduled for elective tonsillectomy\adenotnsillectomy for chronic or recurrent tonsillitis and aged between 6 to 12 years Exclusion Criteria: Known hypersensitivity to medication drugs. Coagulation disorders, thrombocytopenia or active bleeding for any cause. Bronchial asthma. Significant cardiac, renal, pulmonary, hepatic disease or peptic ulcer. The use of any analgesic medications within 24h preoperative or antiplatelet medication within the past 2 weeks.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: diclofenac<br>patients will receive intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously then will continue postoperatively on the same drug received intra-operative. | Drug: diclofenac<br>* non steroidal anti-inflammatory drug<br>* Other names: Voltaren;|
| Active Comparator: ketorolac<br>patients will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg intravenously then will continue postoperatively on the same drug received intra-operative. | Drug: ketorolac<br>* non steroidal anti-inflammatory drug<br>* Other names: Tromethamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relieve | the verbal rating scale (VRS; 0 = no pain, 1 = mild pain, 2 = moderate pain, 3= severe pain, and lastly 4= excruciating pain). VRS assessment will be performed immediately postoperative and 3, 6, 12 and 24h postoperatively | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding | Bleeding score will be assessed by the surgeon at the end of the operation using the following Scale for bleeding assessment (0 = no bleeding, 1 = bleeding as usual, 2 = bleeding more than usual, 3 = profuse, 4 = excessive, and lastly 5 = excessive and continuous). | two weeks | 
| dysphagia | time needed to restore normal dietary habbit | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tonsillectomy, post operative analgesia, diklofanic, ketorolac