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Completed

NCT Number: NCT04230681

Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

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

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Key information

Conditions

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

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

This is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Hydromorphone

Drug

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

Fentanyl

Drug

Fentanyl

Primary outcomes

  1. Number of Patients Requiring Rescue Intravenous Opioid

    Time frame: up to 6 hours post surgery

    Number

Secondary outcomes

  1. Evaluation of Participant's Pain

    Time frame: 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

  2. Evaluation of Participant's SpO2 Saturation

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

    SpO2 %

  3. Respiratory and PONV Events in PACU

    Time frame: up to 6 hours following surgery

  4. Respiratory and PONV Events at Home

    Time frame: up to 7 days following surgery

    Survey sent to parent by email postoperatively

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2020
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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