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NCT Number: NCT06326983

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.

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Key information

Conditions

Tonsillitis Anesthesia Confusion Delirium Emergence Delirium Infections Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Opioid Analgesic Adverse Reaction Otorhinolaryngologic Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Post-operative Nausea and Vomiting (PONV) Postoperative Complications Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases Vomiting

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Waltham, Massachusetts, 02453, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesia classification status I-III
  • Ages 3 years to 17 years
  • Scheduled for tonsillectomy or tonsillotomy with or without adenoidectomy at Boston Children's Hospital Waltham

Exclusion criteria

  • Patients not scheduled for primary tonsillectomy/tonsillotomy.
  • Patients with known coagulopathies
  • Patients with previous chronic pain syndromes
  • Patients with any condition/indication that would prevent them from being able to be randomized (i.e. allergy to one of the study medications)

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia

Other names: Precedex

Acetaminophen

Drug

Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia).

Other names: Ofirmev

Ketorolac

Drug

Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.

Other names: Toradol

Morphine

Drug

Morphine (0.1mg/kg given intravenously at induction of anesthesia)

Primary outcomes

  1. Median Pain Scores in the Post-Anesthesia Care Unit

    Time frame: entry to post-anesthesia care unit to 2-6 hours post-operatively

    Median Pain Scores in the Post-Anesthesia Care Unit measured by the numeric rating scale (NRS), Wong-Baker Faces scale or FLACC (Face, Legs, Activity, Cry, Consolability) scale as indicated based on patient age and development. All scales are done on a 0-10 point scale with 0 being no pain and 10 being the highest pain.

  2. Post-operative pain at 12-24 hours

    Time frame: 12-24 hours post-operatively

    Pain categorized as none, mild, moderate, and severe. Taken from the routine follow-up nursing phone call.

  3. Post Operative Anesthesia Unit Length of Stay (hours)

    Time frame: From entry to the Post Anesthesia Care Unit to exit from the Post-Anesthesia Care Unit. Assessed for up to 8 hours on the date of surgery

    Length of time spent in the Post Operative Anesthesia Unit after tonsil surgery

Secondary outcomes

  1. Opioid rescue medication administration

    Time frame: surgery end to 2-6 hours post-operatively

    Opioid rescue medications administered (reported as oral morphine equivalents)

  2. Emergence Delirium

    Time frame: surgery end to 2-6 hours post-operatively

    Incidence of emergence delirium defined as a score ≥ 10 on the Pediatric Anesthesia Emergence Delirium Scale. Scores range 0-20 with 0 being no agitation/delirium to 20 being the highest level.

  3. Post-operative nausea and vomiting

    Time frame: surgery end to 2-6 hours post-operatively

    Incidence of episodes of emesis or administration of anti-emetics in the post-anesthesia care unit

  4. Procedure length (minutes)

    Time frame: 0-60 minutes

    from incision time to patient being wheeled out of the operating room

  5. Intraoperative Blood pressure (mmHg)

    Time frame: 10 minutes

    Range of systolic blood pressure within 10 minutes of anesthesia induction

  6. Intraoperative Heart rate (beats per second)

    Time frame: 10 minutes

    Range of heart rate within 10 minutes of anesthesia induction

  7. Vasopressor administration

    Time frame: 0-60 minutes

    Intraoperative administration of vasopressors

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery; a Randomized, Controlled, Non-inferiority Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2024
Registry last updated
May 18, 2026

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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