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

NCT ID: NCT03178539

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-12-31

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

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

diclofenac

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.

Group Type: ACTIVE_COMPARATOR

diclofenac

Intervention Type: DRUG

non steroidal anti-inflammatory drug

ketorolac

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.

Group Type: ACTIVE_COMPARATOR

ketorolac

Intervention Type: DRUG

non steroidal anti-inflammatory drug

Interventions

diclofenac

non steroidal anti-inflammatory drug

Intervention Type: DRUG

ketorolac

non steroidal anti-inflammatory drug

Intervention Type: DRUG

Other Intervention Names

Voltaren; Tromethamine

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala S Abdel_Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor, faculty of medicine, Assiut university

Locations

Assiut university hospital

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Other Identifiers

17100114

Identifier Type: -

Identifier Source: org_study_id