| Registry | NCT03178539 |
|---|---|
| Status | Completed |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 100 (Actual) |
| Sponsor | Assiut University (Other) |
| Conditions | Pain, Acute |
| Interventions | diclofenac, ketorolac (Drug) |
| Dates | start 2017-01-31, primary completion 2018-12-31, completion 2018-12-31, first posted 2017-06-07, last updated 2020-07-14 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Pain, Acute All trials of diclofenac All trials of ketorolac
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
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:
1. 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.
2. 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 VRSâ„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 :
1. bleeding tendency
2. Dysphagia.
* Time needed to restore normal dietary habits
| Arm | Type | Interventions | Description |
|---|---|---|---|
| diclofenac | Active comparator | Drug: diclofenac | 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. |
| ketorolac | Active comparator | Drug: ketorolac | 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. |
Sex: All, ages: 6 Years to 12 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Assiut university hospital | Asyut, Asyut Governorate | Egypt |