Supracondylar Humerus FracturePhase 4NCT04905563
NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures
A Phase 4 study testing Acetaminophen-Hydrocodone and Acetaminophen and Ibuprofen in people with Supracondylar Humerus Fracture, run by Le Bonheur Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need surgery. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Supracondylar Humerus Fracture
- What is being tested?
- Acetaminophen-Hydrocodone and Acetaminophen and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2021to 5 Jan 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- isolated supracondylar humerus fracture
- undergoing closed reduction with percutaneous pinning (CRPP)
Who cannot join
- Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone
- Liver or renal disease
- history of bleeding disorder
- medical diagnosis of juvenile arthritis
- on chronic NSAIDs or Opioids PRIOR to the procedure
- medical diagnosis of coagulopathies, open fractures, other injuries at time of diagnosis (multi-system trauma)
- vascular compromise and/or compartment syndrome upon admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Le Bonheur Children's Hospital
Memphis, Tennessee, 38104
About this study
Official title: Post-operative Pain Management in Supracondylar Humerus Fractures: A Randomized, Double-blinded, Prospective Study
The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need surgery. This study will examine whether the combination of acetaminophen and ibuprofen can provide pain control as well as or better than acetaminophen-hydrocodone so that doctors might be able to prescribe less acetaminophen-hydrocodone (which can be addictive) to children in the future. Currently, the standard of care for pain control following this kind of elbow surgery is acetaminophen-hydrocodone.
Read the detailed description
For this study, participants will be randomized (randomly assigned) to either receive scheduled acetaminophen-hydrocodone (which is the current standard of care treatment) or acetaminophen and ibuprofen (the experimental treatment) for post operative pain control following surgery for supracondylar humerus fracture. Patients in the experimental treatment group who require 2 doses of breakthrough pain medication in a row in order to control their pain will be switched to the standard of care treatment. Follow up information regarding outcomes post-discharge will be collected via secure email or text 48-72 hours post-discharge.
- Conditions
- Supracondylar Humerus Fracture
- Being tested
- Acetaminophen-Hydrocodone, Acetaminophen and Ibuprofen
- Keywords
- Elbow surgery, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen-HydrocodoneDrug
Also called Lortab
Narcotic
Acetaminophen and IbuprofenDrug
Also called Tylenol and Advil
Non-narcotic
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose Receives: Drug: Acetaminophen-Hydrocodone |
| Treatment | Experimental | Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen. Receives: Drug: Acetaminophen and Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain).
Measured: 24 hours (duration of post-operative stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start7 Jun 2021
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Why it stopped: Clinical evidence supporting the hypothesis of this study has been published
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Supracondylar Humerus FractureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Le Bonheur Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Campbell Foundation
- Responsible party
- Principal investigator, Lindsey Locke, Le Bonheur Children's Hospital
- Investigators
- Lindsey Locke, MSN, Principal investigator, Le Bonheur Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905563
- Sponsor's protocol ID
- Post-op SCHF Pain
- Status last verified
- Mar 2024
- First submitted
- 21 May 2021
- Last updated
- 8 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No Plan has been made for such data sharing
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Pain Management in Supracondylar Humerus Fractures: A Randomized, Double-blinded, Prospective Study
- ClinicalTrials.gov ID
- NCT04905563
- Acronym / sponsor ID
- Post-op SCHF Pain
- Conditions
- Supracondylar Humerus Fracture
- Keywords
- Elbow surgery, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical evidence supporting the hypothesis of this study has been published
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Le Bonheur Children's HospitalUniversity, hospital or other
- Collaborators
- The Campbell Foundation
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Posted 8 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need surgery. This study will examine whether the combination of acetaminophen and ibuprofen can provide pain control as well as or better than acetaminophen-hydrocodone so that doctors might be able to prescribe less acetaminophen-hydrocodone (which can be addictive) to children in the future. Currently, the standard of care for pain control following this kind of elbow surgery is acetaminophen-hydrocodone.
Detailed description
For this study, participants will be randomized (randomly assigned) to either receive scheduled acetaminophen-hydrocodone (which is the current standard of care treatment) or acetaminophen and ibuprofen (the experimental treatment) for post operative pain control following surgery for supracondylar humerus fracture. Patients in the experimental treatment group who require 2 doses of breakthrough pain medication in a row in order to control their pain will be switched to the standard of care treatment. Follow up information regarding outcomes post-discharge will be collected via secure email or text 48-72 hours post-discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Drug: Acetaminophen-HydrocodoneStandard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose |
| Treatment | Experimental | Drug: Acetaminophen and IbuprofenWeight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- isolated supracondylar humerus fracture
- undergoing closed reduction with percutaneous pinning (CRPP)
Key exclusion criteria (7 listed)
- Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone
- Liver or renal disease
- history of bleeding disorder
- medical diagnosis of juvenile arthritis
- on chronic NSAIDs or Opioids PRIOR to the procedure
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-HydrocodoneAlso: LortabNarcotic | Drug | Control |
| Acetaminophen and IbuprofenAlso: Tylenol and AdvilNon-narcotic | Drug | Treatment |
Primary outcome
Pain Scores
Time frame: 24 hours (duration of post-operative stay)
Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No Plan has been made for such data sharing
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Supracondylar Post-Operative Pain Study
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Management of Vascular Complications in Pediatric Supracondylar Humerus Fractures
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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.
Lindsey Locke, MSN principal investigator
Le Bonheur Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen-Hydrocodone and Acetaminophen and Ibuprofen in people with Supracondylar Humerus Fracture, run by Le Bonheur Children's Hospital 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 8 Mar 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: 24 hours (duration of post-operative stay)). 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 8 Mar 2024.