HypospadiasPhase 3NCT04423107
Assessment of Postop Hypospadias Pain
A Phase 3 study testing Acetaminophen, Ibuprofen and Acetaminophen, Ibuprofen, Oxycodone in people with Hypospadias, run by University of Oklahoma at 1 site in United States.
Trial summary
One of the most common pediatric urology procedures is hypospadias repair, a surgery to correct curvature of the penis and move the urethral meatus into the glans. A survey of pediatric urologists demonstrated that 72% of pediatric urologists prescribe opioid pain medication following the procedure. Read more about this study
- Who is it for?
- Ages 6 to 23 months, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Acetaminophen, Ibuprofen and Acetaminophen, Ibuprofen, Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- All boys undergoing hypospadias repair at our institution between June 2020 and June 2021
Who cannot join
- Boys who have a contraindication to caudal block or Acetaminophen, Ketorolac, Ibuprofen, or Oxycodone use. Boys over 2 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OU Medical Center
Oklahoma City, Oklahoma, 73104
Bhalaajee Meenakshi-Sundaram, MD, 405-271-6900, bhalaajee-meenakshi-sundaram@ouhsc.edu
About this study
Official title: Assessment of Postoperative Pain in Boys Undergoing Hypospadias Repair
One of the most common pediatric urology procedures is hypospadias repair, a surgery to correct curvature of the penis and move the urethral meatus into the glans. A survey of pediatric urologists demonstrated that 72% of pediatric urologists prescribe opioid pain medication following the procedure. Using a validated questionnaire, the investigators aim to quantify how much opioid pain medication boys undergoing hypospadias repair require and if opioid pain medication can be eliminated from the routine postoperative medication regimen.
Read the detailed description
Postoperative pain scores, as measured by the Parents' Postoperative Pain Measure scale, will not be statistically different in boys who receive opioid pain medication postoperatively compared to boys who do not.
The long-term objectives of this study are to understand if pre and postoperative counseling and education along with proper surgical technique will result in less opioid prescriptions following hypospadias repair.
Children with suspected hypospadias will be seen and examined in clinic and offered surgery if appropriate. If the families elect for surgery, this will be performed by one of the investigators between 6-12 months of age. The surgical technique may vary among the investigators. Patients with severe hypospadias may require multiple surgeries for correction.
On the day of surgery, patients will be randomized to receive one of two pain medication regimens:
- Acetaminophen (15 mg/kg) q6h and Ibuprofen (10 mg/kg) q6h
- Acetaminophen q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h prn breakthrough pain for 10 doses Home dosing regimens will be started six hours after the last hospital dose of each medication. The families will be instructed as to when they can give oral medications at home. Lastly, families of both children in both groups will be instructed to contact the clinic or urologist on call if their children are experiencing uncontrolled pain. This may necessitate evaluation in person or adjustment of the current pain regimen. Any deviation from to prescribed pain regimen will be recorded for the study.
Patients will be contacted by phone at 1, 3, and 5 days postoperatively and given a validated questionnaire, the Parents' Postoperative Pain Measure scale, to objectively quantify how much discomfort boys in both groups experienced.
- Conditions
- Hypospadias
- Being tested
- Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen, Oxycodone
- Keywords
- pediatric hypospadias repair
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen, IbuprofenDrug
Also called Tylenol (Acetaminophen)
Acetaminophen (Tylenol) 15 mg/kg q6h and Ibuprofen (10 mg/kg) q6h
Acetaminophen, Ibuprofen, OxycodoneDrug
Also called Tylenol (Acetaminophen)
Acetaminophen (Tylenol) 15 mg/kg q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h
| Study group | Role | What they receive |
|---|---|---|
| No opioid | Active comparator | Acetaminophen every 6 hours and Ibuprofen every 6 hours Receives: Drug: Acetaminophen, Ibuprofen |
| Opioid | Active comparator | Acetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses. Receives: Drug: Acetaminophen, Ibuprofen, Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale
Assessment of postop pain as measured by Parents Postoperative Pain Measurement Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jul 2020
- Primary completionJun 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bhalaajee Meenakshi-Sundaram, MD, Principal investigator, University of Oklahoma HSC, Dept. of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423107
- Sponsor's protocol ID
- Hypospadias Repair Project
- Status last verified
- Jul 2020
- First submitted
- 27 May 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain in Boys Undergoing Hypospadias Repair
- ClinicalTrials.gov ID
- NCT04423107
- Acronym / sponsor ID
- Hypospadias Repair Project
- Conditions
- Hypospadias
- Keywords
- pediatric hypospadias repair
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the most common pediatric urology procedures is hypospadias repair, a surgery to correct curvature of the penis and move the urethral meatus into the glans. A survey of pediatric urologists demonstrated that 72% of pediatric urologists prescribe opioid pain medication following the procedure. Using a validated questionnaire, the investigators aim to quantify how much opioid pain medication boys undergoing hypospadias repair require and if opioid pain medication can be eliminated from the routine postoperative medication regimen.
Detailed description
Postoperative pain scores, as measured by the Parents' Postoperative Pain Measure scale, will not be statistically different in boys who receive opioid pain medication postoperatively compared to boys who do not.
The long-term objectives of this study are to understand if pre and postoperative counseling and education along with proper surgical technique will result in less opioid prescriptions following hypospadias repair.
Children with suspected hypospadias will be seen and examined in clinic and offered surgery if appropriate. If the families elect for surgery, this will be performed by one of the investigators between 6-12 months of age. The surgical technique may vary among the investigators. Patients with severe hypospadias may require multiple surgeries for correction.
On the day of surgery, patients will be randomized to receive one of two pain medication regimens:
- Acetaminophen (15 mg/kg) q6h and Ibuprofen (10 mg/kg) q6h
- Acetaminophen q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h prn breakthrough pain for 10 doses Home dosing regimens will be started six hours after the last hospital dose of each medication. The families will be instructed as to when they can give oral medications at home. Lastly, families of both children in both groups will be instructed to contact the clinic or urologist on call if their children are experiencing uncontrolled pain. This may necessitate evaluation in person or adjustment of the current pain regimen. Any deviation from to prescribed pain regimen will be recorded for the study.
Patients will be contacted by phone at 1, 3, and 5 days postoperatively and given a validated questionnaire, the Parents' Postoperative Pain Measure scale, to objectively quantify how much discomfort boys in both groups experienced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No opioid | Active comparator | Drug: Acetaminophen, IbuprofenAcetaminophen every 6 hours and Ibuprofen every 6 hours |
| Opioid | Active comparator | Drug: Acetaminophen, Ibuprofen, OxycodoneAcetaminophen every 6 hours, Ibuprofen every 6 hours, and Oxycodone every 6 hours as needed for breakthrough pain for 10 doses. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All boys undergoing hypospadias repair at our institution between June 2020 and June 2021
Key exclusion criteria (1 listed)
- Boys who have a contraindication to caudal block or Acetaminophen, Ketorolac, Ibuprofen, or Oxycodone use. Boys over 2 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen, IbuprofenAlso: Tylenol (Acetaminophen)Acetaminophen (Tylenol) 15 mg/kg q6h and Ibuprofen (10 mg/kg) q6h | Drug | No opioid |
| Acetaminophen, Ibuprofen, OxycodoneAlso: Tylenol (Acetaminophen)Acetaminophen (Tylenol) 15 mg/kg q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h | Drug | Opioid |
Primary outcome
Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale
Time frame: 1 year
Assessment of postop pain as measured by Parents Postoperative Pain Measurement Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Hypospadias
Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
Ureteropelvic Junction Obstruction, Hypospadias
Recruiting
Worldwide Yearly Screening for Hypospadias
Hypospadias
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruiting
Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.
Perioperative Bleeding During Recurrent Hypospadias Repair
Not yet recruiting
Efficacy of PRF in Hypospadias Repair
Hypospadias
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhalaajee Meenakshi-Sundaram, MD principal investigator
University of Oklahoma HSC, Dept. of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetaminophen, Ibuprofen and Acetaminophen, Ibuprofen, Oxycodone in people with Hypospadias, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bhalaajee Meenakshi-Sundaram, MD (405-271-6900, Bhalaajee-meenakshi-sundaram@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of postop pain measured by Parents Postoperative Pain Measurement Scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.