Clinical trial NCT03178539: Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management
Official title: Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain, Acute
Keywords: tonsillectomy
post operative analgesia
diklofanic
ketorolac
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: pain relieve
timeFrame: 24 hours
Secondary outcomes:
measure: bleeding
timeFrame: two weeks
measure: dysphagia
timeFrame: two weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
state: Asyut Governorate
Study officials:
affiliation: Assistant professor, faculty of medicine, Assiut university
name: Hala S Abdel_Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: