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

NCT ID: NCT02603848

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2024-02-29

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.

Detailed Description

The primary objective of this study is to determine the efficacy of ibuprofen in reducing postoperative pain in children recovering from inguinal surgery when compared to morphine. Thus, if stated as a research question, the problem to be addressed is: in children (10 months-5 years) who have recently undergone inguinal surgery, is ibuprofen, when administered postoperatively, no less effective in reducing postoperative pain compared to morphine? Inguinal surgical procedures (unilateral hernia/ hydrocele repair and unilateral orchidopexy) will be carried out under standardized analgesic administration. Anesthesia will be delivered to all participants via inhalation induction with air/nitrous oxide and sevoflurane, intravenous supplementation with propofol and/or fentanyl 1 to 2 mcg/kg, antiemetic prophylaxis with dexamethasone 150 mcg/kg and ondansetron 50 mcg/kg, acetaminophen suppository 40 mg/kg, and morphine intravenous 50-100 mcg/kg. Regional block with local infiltration of 0.25 % of plain bupivacaine will be performed around the vicinity of the ileoinguinal nerve. This anesthesia protocol has been approved by a consensus meeting with the Pediatric Anesthesia Group at McMaster University and will be employed consistently in all cases in this study. Deviations to this practice will lead to study exclusion.

Postoperatively, the control group will receive standardized 0.2 mg/ kg morphine syrup (maximum 10mg) every four hours as needed, while the intervention group will receive Ibuprofen suspension (10mg/kg; maximum 600 mg) every six hours as needed for 48 hours post hospital discharge. Tylenol (15mg/kg) can be administered in either group at parental discretion every four hours as needed and will be recorded in a standardized medication log provided to all parents.

Parents will be told to follow the instructions on the package of prefilled syringes (i.e. to give the medication every 4 hours or 6 hours as needed) by the healthcare practitioner who is discharging the patient from the hospital. Parents and will not be told which medication their child is receiving in order to maintain blinding. All dosage information will be kept and maintained by the research pharmacy staff. Parents will be provided medication information through the use of a standardized script and hand out available in both English and French which will encompass potential side effects of both trial medications.

The duration of the treatment period will be following hospital discharge, after the inguinal surgical procedure, to 48 hours post-hospital discharge.

Primary Outcome Measurement Tool: 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) (See Appendix A).10 Pain scales will only be administered by parents once the patient has been discharged home. Patients usually recover from surgery for an average of two hours prior to being discharged from hospital.

Secondary Outcomes Measurement Tool: Secondary outcomes will be measured as follows: 1) Analgesic use postoperatively while still in the hospital. This will be recorded by a member of the care team on the patient's chart. Parents will record supplemental Tylenol administered in a standardized medication log for both arms of the study; 2) Frequency of emesis during recovery phase (in hospital and post discharge) recorded on patient case report form and recorded from the 48 hour phone call. 3) Time to discharge will be recorded from patient discharge sheet by research assistant 4) Adverse reactions (post discharge) will be recorded on patient case report form 5) Surgical complications (surgical site infection, bleeding, wound dehiscence) will be assessed by a physician or nurse practitioner at 6-8 week follow-up visit 6) First bowel movement post-surgery.

Conditions

Inguinal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ibuprofen suspension

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

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

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

Interventions

Ibuprofen

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

Intervention Type: DRUG

Morphine

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

Intervention Type: DRUG

Other Intervention Names

Advil; Morphine sulfate

Eligibility Criteria

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

• Minimum Eligible Age: 10 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster Surgical Associates

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis Braga, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Luis Braga, MD

Role: CONTACT

braga@mcmaster.ca

905-521-2100 ext. 73777

Melissa McGrath

Role: CONTACT

mcgram2@mcmaster.ca

905-521-2100 ext. 73654

Facility Contacts

Luis Braga, MD

Role: primary

braga@mcmaster.ca

905-521-2100 ext. 73777

Other Identifiers

Ibuprofen vs. Morphine

Identifier Type: -

Identifier Source: org_study_id