Who is sponsoring NCT04905563?

NCT04905563 is sponsored by Le Bonheur Children's Hospital.

What drugs are being tested in NCT04905563?

Interventions in NCT04905563: Acetaminophen-Hydrocodone, Acetaminophen and Ibuprofen.

What condition does NCT04905563 study?

NCT04905563 studies Supracondylar Humerus Fracture.

Is NCT04905563 still recruiting?

NCT04905563 is currently terminated. Last updated 8 March 2024.

Are results published for NCT04905563?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-03-08 · How we verify

NCT04905563

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures

Terminated Phase 4 Results posted Last updated 8 March 2024

What this trial tests

Phase 4 trial testing Acetaminophen-Hydrocodone in Supracondylar Humerus Fracture in 30 participants. Terminated before completion.

Timeline

7 June 2021

Primary endpoint
5 January 2024

5 January 2024

Quick facts

Lead sponsor	Le Bonheur Children's Hospital
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	30
Start date	7 June 2021
Primary completion	5 January 2024
Estimated completion	5 January 2024
Sites	1 location across United States

Drugs / interventions tested

Acetaminophen-Hydrocodone — full drug profile →
Acetaminophen and Ibuprofen — full drug profile →

Conditions studied

Supracondylar Humerus Fracture — all drugs for Supracondylar Humerus Fracture →

Sponsor

Le Bonheur Children's Hospital

Who can join

Adults 4 to 13, any sex, with Supracondylar Humerus Fracture. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Scores Primary · 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).

Group	Value	95% CI
Control	0.95	± 1.35
Treatment	0.97	± 1.53

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Supracondylar Humerus Fracture

Currently open trials in the same condition.

NCT07429344 — EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of · recruiting
NCT07212036 — The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures · NA · recruiting
NCT06496672 — The Wrist-Free Study - Comparing Traditional Above Elbow Casts to Ones That Free the Wrist · NA · recruiting
NCT03759028 — Supracondylar Post-Operative Pain Study · Phase 4 · recruiting

Other Le Bonheur Children's Hospital trials

Trials by the same sponsor.

NCT04205877 — The U.S. PDA Registry · not yet recruiting
NCT04222101 — Association of Insulin Resistance and FGF21 on Cardiac Function in Pediatric Dilated Cardiomyopathy · NA · terminated
NCT03897335 — Preventing Acute Kidney Injury (AKI) in Pediatric Patients · Phase 3 · unknown
NCT03860012 — Folic Acid in Pediatric Inflammatory Bowel Disease · Phase 4 · unknown
NCT03510091 — Video-Assisted Counseling for HPV Vaccination · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04905563 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Le Bonheur Children's Hospital
Last refreshed: 8 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04905563.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing