Ibuprofen for Inguinal Surgery

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Inguinal SurgeryIbuprofen - Drug
Eligibility
10 - 5
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Inguinal Surgery

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Group A: All oral pre-operative analgesics
1
Experimental
1
IT Injection

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: From the time surgical procedure is completed to discharge from the hospital. (Typically two to four hours)

Any complications that arise during the patient's recovery at the hospital (Typically two to four hours)
Adverse reactions (during hospital stay)
From the time surgical procedure is completed to discharge from the hospital. (Typically two to four hours)
Frequency of emesis (during hospital stay)
Measured dosage post-surgery (on average 45 minutes later)
Analgesic use post-operatively
Hour 48
Pain scales Post-Discharge from Hospital
Surgical complications will be seen at the patient's 48-hour follow-up visit.
Surgical complications
Day 3
First bowel movement post-surgery
Time from the end of the surgical procedure to discharge from hospital. (Typically two to four hours)
Time to Discharge

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
Group A: All oral pre-operative analgesics
2
Experimental
1
IT Injection

Trial Design

2 Treatment Groups

Morphine Sulfate suspension
1 of 2
Ibuprofen suspension
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Ibuprofen · No Placebo Group · N/A

Ibuprofen suspension
Drug
Experimental Group · 1 Intervention: Ibuprofen · Intervention Types: Drug
Morphine Sulfate suspension
Drug
ActiveComparator Group · 1 Intervention: Morphine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the time surgical procedure is completed to discharge from the hospital. (typically two to four hours)

Who is running the clinical trial?

McMaster UniversityLead Sponsor
801 Previous Clinical Trials
1,727,757 Total Patients Enrolled
McMaster Surgical AssociatesOTHER
16 Previous Clinical Trials
46,622 Total Patients Enrolled
Luis Braga, MDPrincipal InvestigatorMcMaster University
2 Previous Clinical Trials
386 Total Patients Enrolled

Eligibility Criteria

Age 10 - 5 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have inguinal hernia or hydrocele, or undescended testes requiring surgical intervention by a trained physician.
You are 10 months to 5 years old.
References

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