NCT04230681 is a EARLY_PHASE1 clinical trial of Hydromorphone in Obstructive Sleep Apnea, sponsored by Washington University School of Medicine.

Who is sponsoring NCT04230681?

NCT04230681 is sponsored by Washington University School of Medicine.

What drugs are being tested in NCT04230681?

Interventions in NCT04230681: Hydromorphone, Fentanyl.

What condition does NCT04230681 study?

NCT04230681 studies Obstructive Sleep Apnea, Tonsillitis.

Is NCT04230681 still recruiting?

NCT04230681 is currently completed. Last updated 18 December 2024.

Are results published for NCT04230681?

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

Last reviewed 2024-12-18 · How we verify

NCT04230681

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

Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

Completed EARLY_PHASE1 Results posted Last updated 18 December 2024

What this trial tests

EARLY_PHASE1 trial testing Hydromorphone in Obstructive Sleep Apnea in 189 participants. Completed in 1 April 2022.

Timeline

26 February 2020

Primary endpoint
1 April 2022

1 April 2022

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	189
Start date	26 February 2020
Primary completion	1 April 2022
Estimated completion	1 April 2022
Sites	1 location across United States

Drugs / interventions tested

Hydromorphone (HYDROMORPHONE) — full drug profile →
Fentanyl (fentanyl) — full drug profile →

Conditions studied

Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
Tonsillitis — all drugs for Tonsillitis →

Sponsor

Washington University School of Medicine

Who can join

Adults 2 to 15, any sex, with Obstructive Sleep Apnea or Tonsillitis. 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.

Number of Patients Requiring Rescue Intravenous Opioid Primary · up to 6 hours post surgery

Number

Group	Value	95% CI
Hydromorphone	48
Fentanyl	66

Evaluation of Participant's Pain Secondary · Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.

Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain

0min

Group	Value	95% CI
Hydromorphone	2.8	± 3.5
Fentanyl	4.3	± 3.9

5min

Group	Value	95% CI
Hydromorphone	2.7	± 3.5
Fentanyl	3.7	± 3.9

10min

Group	Value	95% CI
Hydromorphone	2.3	± 3.1
Fentanyl	3.5	± 3.6

15min

Group	Value	95% CI
Hydromorphone	2.3	± 2.5
Fentanyl	3.4	± 3.3

30min

Group	Value	95% CI
Hydromorphone	1.7	± 2.6
Fentanyl	2.7	± 2.9

45min

Group	Value	95% CI
Hydromorphone	0.7	± 1.4
Fentanyl	2.4	± 2.4

60min

Group	Value	95% CI
Hydromorphone	0.5	± 1.1
Fentanyl	2.1	± 2.0

Evaluation of Participant's SpO2 Saturation Secondary · Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.

SpO2 %

0min

Group	Value	95% CI
Hydromorphone	96.9	± 2.7
Fentanyl	96.6	± 2.7

5min

Group	Value	95% CI
Hydromorphone	97.3	± 2.8
Fentanyl	96.1	± 9.6

10min

Group	Value	95% CI
Hydromorphone	97.4	± 2.2
Fentanyl	97.3	± 2.5

15min

Group	Value	95% CI
Hydromorphone	97.1	± 2.7
Fentanyl	97.7	± 2.1

30min

Group	Value	95% CI
Hydromorphone	96.9	± 2.1
Fentanyl	96.8	± 9.0

45min

Group	Value	95% CI
Hydromorphone	96.8	± 2.2
Fentanyl	97.6	± 1.7

60min

Group	Value	95% CI
Hydromorphone	96.7	± 2.3
Fentanyl	97.4	± 2.0

Respiratory and PONV Events in PACU Secondary · up to 6 hours following surgery

Group	Value	95% CI
Hydromorphone	3
Fentanyl	4
Hydromorphone	9
Fentanyl	11
Hydromorphone	1
Fentanyl	2
Hydromorphone	77
Fentanyl	73

Respiratory and PONV Events at Home Secondary · up to 7 days following surgery

Survey sent to parent by email postoperatively

Group	Value	95% CI
Hydromorphone	10
Fentanyl	13
Hydromorphone	7
Fentanyl	9
Hydromorphone	1
Fentanyl	2
Hydromorphone	46
Fentanyl	35

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Hydromorphone

Serious: 0/90 (0%)

Deaths: 0/90

Fentanyl

Serious: 0/90 (0%)

Deaths: 0/90

Other adverse events (8 terms — click to expand)

Reaction	System	Hydromorphone	Fentanyl
Prolonged admission for poor oral intake	Gastrointestinal disorders	—	—
Postoperative tonsillar bleed	Blood and lymphatic system disorders	—	—
Readmitted for nausea or vomiting	Gastrointestinal disorders	—	—
Prolonged admission for nausea or vomiting	Gastrointestinal disorders	—	—
Fever	Infections and infestations	—	—
Tongue Injury	Skin and subcutaneous tissue disorders	—	—
Readmitted for urinary retention	Renal and urinary disorders	—	—
Postoperative Hypotension	Vascular disorders	—	—

Data from ClinicalTrials.gov NCT04230681 adverse events section.

Sponsor's own description

A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Hydromorphone

Trials testing the same drug.

NCT06868589 — Reducing Pain With Methadone and Ketamine in Liver Transplant · Phase 4 · active not recruiting
NCT06949059 — Intravenous Hydromorphone for the Treatment of Acute Pain · Phase 1, PHASE2 · recruiting
NCT06525740 — Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery · Phase 4 · recruiting
NCT06406400 — Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics o · Phase 1 · terminated
NCT06411795 — Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatodu · Phase 2 · recruiting

Other recruiting trials for Obstructive Sleep Apnea

Currently open trials in the same condition.

NCT07195253 — Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome · recruiting
NCT07273019 — Tongue Muscular Assessment in Children With Sleep Disordered Breathing · NA · recruiting
NCT07447011 — Glaucoma Respsosne to Lifestyle Corrections in Sleep Apnea · NA · recruiting
NCT07397780 — RPMO2 Oximeter Accuracy During Sleep 1 Trial · active not recruiting
NCT06698809 — Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness · NA · recruiting

Other Washington University School of Medicine trials

Trials by the same sponsor.

NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer · Phase 2 · not yet recruiting
NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer · Phase 2 · not yet recruiting
NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) · Phase 1 · not yet recruiting
NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients · not yet recruiting
NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting

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 NCT04230681 (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 Washington University School of Medicine
Last refreshed: 18 December 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/NCT04230681.

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