Ibuprofen vs Morphine for Pediatric Postoperative Pain

Recruiting in Palo Alto (17 mi)

Overseen byLuis Braga, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McMaster University

No Placebo Group

Trial Summary

What is the purpose of this trial?

Morphine is now the most commonly used opioid in children for pain management even though the safety of morphine use in children is a primary concern for parents as it is perceived to have more associated risks. Ibuprofen and other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) have also been shown to be effective for the management of postoperative pain with fewer associated adverse effects. However, there have been concerns that utilization of ibuprofen alone may lead to inadequate pain management. Evidence of whether ibuprofen is equally effective as morphine for postoperative pain control in pediatric inguinal surgery is lacking and needs to be further explored as a measure to potentially reduce opioid exposure in children. To determine which drug is more effective for relieving post-operative pain, this trial will compare the effectiveness of ibuprofen and morphine at reducing post-operative pain, and the amount of analgesic use required post-surgery.

Research Team

Luis Braga, MD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for children aged 10 months to 5 years needing inguinal surgery, such as for hernias or undescended testes. It's not open to those with a history of NSAID or opioid use, previous inguinal surgeries, other serious health issues, kidney or liver failure, blood clotting disorders, or asthma.

Inclusion Criteria

You have a hernia, hydrocele, or undescended testes that need surgery by a doctor.

Patients requiring inguinal day surgery

Children who are between 10 months and 5 years old when they go to the clinic.

Exclusion Criteria

You have been diagnosed with asthma or a condition that restricts your airways.

Deviation to pre-established anesthesia protocol

You regularly take nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids.

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Treatment Details

Interventions

Ibuprofen (Non-Steroidal Anti-Inflammatory Drug)
Morphine (Opioid Analgesic)

Trial OverviewThe study aims to compare the effectiveness of ibuprofen versus morphine in managing postoperative pain in kids after inguinal surgery. It will measure how well each drug controls pain and the amount of additional pain relief needed after the operation.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Ibuprofen suspensionExperimental Treatment1 Intervention

Ibuprofen suspension (Advil) will be administered orally at a dose of 10mg/kg every 6 hours for 72 hours post-surgery.

Group II: Morphine Sulfate suspensionActive Control1 Intervention

Morphine sulfate suspension will be administered orally at a dose of 0.02 - 0.04 mg/kg every 6 hours for 72 hours post-surgery.

Ibuprofen is already approved in Canada, Japan, China, Switzerland for the following indications: