Pain, Acute
Conditions
Keywords
tonsillectomy, post operative analgesia, diklofanic, ketorolac
Brief summary
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
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 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 : 1. bleeding tendency 2. Dysphagia. * Time needed to restore normal dietary habits
Interventions
DRUGdiclofenac
non steroidal anti-inflammatory drug
DRUGketorolac
non steroidal anti-inflammatory drug
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain relieve | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bleeding | 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). |
| dysphagia | two weeks | time needed to restore normal dietary habbit |
Countries
Egypt
Outcome results
None listed