Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

NCT04230681 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: 201912042UL1TR002345
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea; Tonsillitis

Outcome Measures

Primary Outcomes (1)

• Number of Patients Requiring Rescue Intravenous Opioid

  Number

  up to 6 hours post surgery

Secondary Outcomes (4)

• Evaluation of Participant's Pain

  Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.

• Evaluation of Participant's SpO2 Saturation

  Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.

• Respiratory and PONV Events in PACU

  up to 6 hours following surgery

• Respiratory and PONV Events at Home

  up to 7 days following surgery

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

Drug: Fentanyl

Hydromorphone

ACTIVE COMPARATOR

Drug: Hydromorphone

Interventions

Hydromorphone DRUG

Patients will be randomized to one of two opioids for the treatment of post-operative pain.

Hydromorphone

Fentanyl DRUG

Fentanyl

Fentanyl

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children ages 2 to 15 years old
• Presenting for tonsillectomy or adenotonsillectomy surgery
• American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3
• Provide Informed Consent / Assent (as appropriate)

You may not qualify if:

• Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures
• Revision tonsillectomy or revision adenotonsillectomy surgery
• Known pregnancy
• Any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• Friedman NR, Perkins JN, McNair B, Mitchell RB. Current practice patterns for sleep-disordered breathing in children. Laryngoscope. 2013 Apr;123(4):1055-8. doi: 10.1002/lary.23709. Epub 2013 Feb 4.

  PMID: 23382017 BACKGROUND

• Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.

  PMID: 21539679 BACKGROUND

• Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.

  PMID: 20974339 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Tonsillitis

Interventions

Hydromorphone; Fentanyl

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Greg Miller
• Organization: Washington University

g.c.miller@wustl.edu

314-454-6000

Study Officials

• Michael Montana, MD PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 18, 2020
• Study Start: February 26, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: December 18, 2024
• Results First Posted: December 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)