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Non-Steroidal Anti-Inflammatory Drug

Ibuprofen vs Morphine for Pediatric Postoperative Pain

N/A
Recruiting
Led By Luis Braga, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up surgical complications will be seen at the patient's 48-hour follow-up visit.
Awards & highlights

Study Summary

This trial will compare the effectiveness of ibuprofen and morphine at reducing post-operative pain in children, and the amount of analgesic use required post-surgery.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Ibuprofen may cause less severe side effects like stomach upset and bleeding risks. Morphine can lead to more significant concerns such as respiratory depression (slowed breathing), constipation, nausea, vomiting, and potential dependency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain scales Post-Discharge from Hospital
Secondary outcome measures
Adverse reactions (during hospital stay)
Analgesic use post-operatively
First bowel movement post-surgery
+3 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen
2013
Completed Phase 4
~5800

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
880 Previous Clinical Trials
2,597,728 Total Patients Enrolled
McMaster Surgical AssociatesOTHER
16 Previous Clinical Trials
46,419 Total Patients Enrolled
Luis Braga, MDPrincipal InvestigatorMcMaster University
2 Previous Clinical Trials
386 Total Patients Enrolled

Media Library

Ibuprofen (Non-Steroidal Anti-Inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT02603848 — N/A
Inguinal Surgery Research Study Groups: Ibuprofen suspension, Morphine Sulfate suspension
Inguinal Surgery Clinical Trial 2023: Ibuprofen Highlights & Side Effects. Trial Name: NCT02603848 — N/A
Ibuprofen (Non-Steroidal Anti-Inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02603848 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarian participants being recruited for this research initiative?

"This research project is primarily geared towards those between 10 months and 5 years of age. Moreover, there are 99 separate trials available for minors under 18 years old and 432 studies designed to benefit senior citizens aged 65 or older."

Answered by AI

What criteria must prospective participants satisfy to be eligible for this research?

"This clinical experimentation requires the enrollment of a hundred pediatric patients between 10 months and 5 years. The children need to be suffering from inguinal hernia, hydrocele or undescended testes that necessitates surgical intervention by a qualified medical practitioner in addition to requiring day surgery procedure for inguinal pain post-operation."

Answered by AI

In what circumstances is Ibuprofen typically prescribed?

"Ibuprofen has many applications, such as ameliorating catarrh and providing relief from muscle spasms, medical procedures, and fever."

Answered by AI

In what other research initiatives has Ibuprofen been utilized?

"Currently, 95 clinical trials are utilizing ibuprofen as a therapeutic intervention. 25 of these studies are in the final stage (Phase 3) with 216 distinct medical facilities participating across the country; most notably Boston, Massachusetts is at the centre of this research."

Answered by AI

Is there still an opportunity to get involved in this research?

"Confirmed, according to clinicaltrials.gov this experiment is still actively recruiting participants. The posted advertisement dates back to February 27th 2017 and was most recently modified on May 13th 2022."

Answered by AI

What is the sample size of this clinical experiment?

"Affirmative, the information on clinicaltrials.gov suggests that this research is presently searching for participants. This investigation was initially made public on February 27th 2017 and was recently updated on May 13th 2022. A total of 100 patients must be found across 1 location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ibuprofen Compared to Morphine as a Pediatric Postoperative Pain Management Tool Following Inguinal Surgery
2017. "Ibuprofen Compared to Morphine as a Pediatric Postoperative Pain Management Tool Following Inguinal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02603848.
~12 spots leftby Apr 2025
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