The effect of intravenous ibuprofen on postoperative pain and opioid consumption after pediatric cardiac surgery: A randomized, double-blind, controlled study

Phase 1

Recruiting

• Conditions: Surgery; Paediatrics; Anaesthesia

• Registration Number: PACTR202106606222881
• Lead Sponsor: Mansoura university children hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-21
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1-patients of either sex.
2- with their age ranging from 2 to 12 years.
3-submitted for on pump elective repair of congenital simple left to right intra cardiac shunt via median sternotomy.

Exclusion Criteria

1-refusal of their guardians
2-redo cardiac surgery
3-hypersensitivity to ibuprofen
4-coagulation disorders, renal, hepatic or pulmonary disease
5-heart failure and moderate to severe pulmonary hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total dose of fentanyl requirements in the first postoperative 24 hours.

Secondary Outcome Measures

Name	Time	Method
1- Post operative pain that will be assessed at 1h, 2h, 6h, 12h, 18, 24 after extubation, and will be managed according to objective pain discomfort score(OPDS) in children.<br>2- Total dose of intra operative fentanyl requirements(ug/kg).<br>3- Aortic cross clamping time (minutes).<br>4- Cardiopulmonary bypass time (minutes).<br>5-The number of patients who will be extubated in operating room (within 15 minutes of the end of surgery) were recorded.<br>6- Time to extubation (hours). <br>7- Post extubation PaO2, PaCO2 will be assessed each 3 hour for 24 hours.<br>8-Time of first rescue analgesia <br>10- Intensive care unit (ICU) length of stay. <br>