Recruiting

Ibuprofen vs. Morphine

Sponsor:

McMaster University

Code:

NCT02603848

Conditions

Inguinal Surgery

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

Interventions

Ibuprofen

Morphine

Study Details

Brief summary:

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.

Conditions

Inguinal Surgery

Study ID

NCT02603848

Start date

Feb 27, 2017

Status verified date

Mar, 2023

Completion date

Feb, 2024

Anticipated

Primary completion date

Feb, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Pediatric Patients between the ages of 10 months-5 years at presentation to clinic
2. Patients diagnosed with inguinal hernia or hydrocele, or undescended testes requiring surgical intervention by a trained physician
3. Patients requiring inguinal day surgery

Exclusion Criteria:

1. Patients who have undergone previous inguinal surgery
2. Patients with other co-morbidities
3. Patients unable to be prescribed Ibuprofen or Morphine
4. Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDS) or opioids
5. Patients with renal or hepatic failure
6. Patients with coagulation disorders
7. Deviation to pre-established anesthesia protocol
8. Patients diagnosed with asthma or restrictive airways

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ibuprofen suspension

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

active comparator: Morphine Sulfate suspension

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.

Interventions

Ibuprofen

(10mg/kg; maximum 600 mg) every six hours as needed

Morphine

0.2 mg/ kg morphine suspension (maximum 10mg) every four hours as needed

Primary outcome measure

  • Pain scales Post-Discharge from Hospital [ Time Frame: Postoperative pain will be measured at three time the evening of the procedure, 24 hours post-discharge and 48 hours post-discharge) using the validated Parents Postoperative Pain Measure (PPPM) ]

Central Contacts and Locations

Central contacts

Luis Braga, MD

905-521-2100braga@mcmaster.ca

Melissa McGrath

905-521-2100mcgram2@mcmaster.ca

Locations

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Luis Braga, MD

905-521-2100braga@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Mar 15, 2023

Last verified

Mar, 2023

Keywords

  • Inguinal surgery
  • Hernia Repair
  • Orchidopexy
  • Hydrocele
  • Pediatric
  • Post-operative pain
  • Morphine sulfate
  • Ibuprofen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2023-03-15.