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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03178539
Other study ID # 17100114
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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