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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
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;
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diclofenac | Active Comparator | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diclofenac | Drug | non steroidal anti-inflammatory drug |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hala S Abdel_Ghaffar, MD | Assistant professor, faculty of medicine, Assiut university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospital | Asyut | Asyut Governorate | 715715 | Egypt |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D020910 | Ketorolac |
| D014325 | Tromethamine |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| ketorolac | Drug | non steroidal anti-inflammatory drug |
|
|
time needed to restore normal dietary habbit |
| two weeks |
| D007213 |
| Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |