Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326983
• Other study ID #: IRB-P00047028
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: May 2024
• Source: Boston Children's Hospital
• Contact: Jocelyn Booth, BSN
• Phone: 857-218-4585
• Email: jocelyn.booth[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: April 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia
• Emergence Delirium
• Opioid Analgesic Adverse Reaction
• Pain
• Post-operative Nausea and Vomiting (PONV)
• Postoperative Nausea and Vomiting
• Tonsillitis
• Vomiting

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia
• Acetaminophen
Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia).
• Ketorolac
Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
• Morphine
Morphine (0.1mg/kg given intravenously at induction of anesthesia)

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Pain Scores in the Post-Anesthesia Care Unit	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.	entry to post-anesthesia care unit to 2-6 hours post-operatively
Primary	Post-operative pain at 12-24 hours	Pain categorized as none, mild, moderate, and severe. Taken from the routine follow-up nursing phone call.	12-24 hours post-operatively
Primary	Post Operative Anesthesia Unit Length of Stay (hours)	Length of time spent in the Post Operative Anesthesia Unit after tonsil surgery	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
Secondary	Opioid rescue medication administration	Opioid rescue medications administered (reported as oral morphine equivalents)	surgery end to 2-6 hours post-operatively
Secondary	Emergence Delirium	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.	surgery end to 2-6 hours post-operatively
Secondary	Post-operative nausea and vomiting	Incidence of episodes of emesis or administration of anti-emetics in the post-anesthesia care unit	surgery end to 2-6 hours post-operatively
Secondary	Procedure length (minutes)	from incision time to patient being wheeled out of the operating room	0-60 minutes
Secondary	Intraoperative Blood pressure (mmHg)	Range of systolic blood pressure within 10 minutes of anesthesia induction	10 minutes
Secondary	Intraoperative Heart rate (beats per second)	Range of heart rate within 10 minutes of anesthesia induction	10 minutes
Secondary	Vasopressor administration	Intraoperative administration of vasopressors	0-60 minutes