Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pain, Acute

Treatments: Drug: ketorolac; Drug: diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT03178539

17100114

Details and patient eligibility

About

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

Full 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

Enrollment: 100 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

diclofenac

Active Comparator group

Description:

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.

Treatment:

Drug: diclofenac

ketorolac

Active Comparator group

Description:

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.

Treatment:

Drug: ketorolac