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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178539
• Other study ID #: 17100114
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 31, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Drug:
• diclofenac
non steroidal anti-inflammatory drug
• ketorolac
non steroidal anti-inflammatory drug

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut	Asyut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain relieve	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	24 hours
Secondary	bleeding	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).	two weeks
Secondary	dysphagia	time needed to restore normal dietary habbit	two weeks