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Analgesic

No opioid for Hypospadias

Phase 3
Waitlist Available
Led By Bhalaajee Meenakshi-Sundaram, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All boys undergoing hypospadias repair at our institution between June 2020 and June 2021
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether boys who have had surgery to correct a curved penis need opioids for pain afterwards.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale

Trial Design

2Treatment groups
Active Control
Group I: No opioidActive Control1 Intervention
Acetaminophen every 6 hours and Ibuprofen every 6 hours
Group II: OpioidActive Control1 Intervention
Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,460 Total Patients Enrolled
Bhalaajee Meenakshi-Sundaram, MDPrincipal InvestigatorUniversity of Oklahoma HSC, Dept. of Urology

Frequently Asked Questions

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

Are there long-term repercussions to No opioid use?

"No opioids have been proven safe in Phase 3 trials, so they were given a score of 3."

Answered by AI

What does No opioid typically alleviate for patients?

"Catarrh, rhinorrhoea, musculoskeletal pain, and muscle spasms can all be treated effectively with No opioid."

Answered by AI

How many people have been invited to participate in this medical study?

"The information available on clinicaltrials.gov supports that this trial is looking for patients right now. This trial was first posted on 7/1/2020 and was last updated a month ago on 7/30/2020. They are looking for 150 patients to participate at 1 location."

Answered by AI

What are the primary inclusion criteria for this clinical trial?

"This clinical trial is currently looking for 150 young boys that have been diagnosed with hypospadias. The participants should be between 6 and 23 months old and meet the following additional qualifications: All boys undergoing hypospadias repair at our institution between June 2020 and June 2021."

Answered by AI

Is the age limit for this research project restricted to people who are fifty years or younger?

"This trial is for children aged between 6 months to 23 months old. Out of the 137 total studies, this is the 52nd study for patients under 18 and the 85th study for patients over 65."

Answered by AI

Are there other examples of successful clinical trials that have not included opioids?

"As of right now, there are 131 active trials researching No opioid. Out of these, 38 are in Phase 3. Even though a large portion of the research is taking place in Pittsburgh, Pennsylvania, there are 1050 locations running studies for No opioid."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Assessment of Postop Hypospadias Pain
2020. "Assessment of Postop Hypospadias Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04423107.
~32 spots leftby Apr 2025
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