Assiut university hospital
Asyut, Asyut Governorate, 715715, Egypt
NCT Number: NCT03178539
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
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Notify Me6 year–12 year
All sexes
Interventional
Phase 2 / Phase 3
Asyut, Asyut Governorate, 715715, Egypt
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:
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.
IV. Late Post-operative data:
As aweekly follow up for 2 weeks :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
non steroidal anti-inflammatory drug
Other names: Voltaren
non steroidal anti-inflammatory drug
Other names: Tromethamine
Time frame: 24 hours
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
Time frame: two weeks
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).
Time frame: two weeks
time needed to restore normal dietary habbit
Assiut University
Other
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