Assessing the Effectiveness of Ibuprofen Compared to Morphine as a Pediatric Postoperative Pain Management Tool Following Inguinal Surgery (AIMS)

Ibuprofen vs. Morphine

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.

2017-02-27

2024-02-01

2024-02-01

Recruiting

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-03-15