Ibuprofen Compared to Morphine as a Pediatric Postoperative Pain Management Tool Following Inguinal Surgery

NCT02603848 | Unknown DMC

• 1 other identifier: Ibuprofen vs. Morphine
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain scales Post-Discharge from Hospital

  Assessed through validated and reliable Parents Postoperative Pain Measure (PPPM) by trained and blinded parent/guardian at 24 hours and at 48 hour following discharge from the hospital.

  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)

Secondary Outcomes (6)

• Analgesic use post-operatively

  Measured dosage post-surgery (on average 45 minutes later)

• Frequency of emesis (during hospital stay)

  From the time surgical procedure is completed to discharge from the hospital. (Typically two to four hours)

• Time to Discharge

  Time from the end of the surgical procedure to discharge from hospital. (Typically two to four hours)

• Adverse reactions (during hospital stay)

  Any complications that arise during the patient's recovery at the hospital (Typically two to four hours)

• Surgical complications

  Surgical complications will be seen at the patient's 48-hour follow-up visit.

Study Arms (2)

Ibuprofen suspension

EXPERIMENTAL

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

Drug: Ibuprofen

Morphine Sulfate suspension

ACTIVE COMPARATOR

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.

Drug: Morphine

Interventions

Ibuprofen DRUG

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

Also known as: Advil

Ibuprofen suspension

Morphine DRUG

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

Also known as: Morphine sulfate

Morphine Sulfate suspension

Eligibility Criteria

• Age: 10 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• McMaster Surgical Associates: collaborator

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

MeSH Terms

Conditions

Testicular Hydrocele; Pain, Postoperative

Interventions

Ibuprofen; Morphine

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Luis Braga, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Braga, MD

CONTACT

905-521-2100; braga@mcmaster.ca

Melissa McGrath

CONTACT

905-521-2100; mcgram2@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: November 13, 2015
• Study Start: February 27, 2017
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

CA (1)