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.
Conditions
Tonsillitis, Post-operative Nausea and Vomiting (PONV), Emergence Delirium, Opioid Analgesic Adverse Reaction, Anesthesia, Pain
Recruitment Status
RECRUITING
Eligibility Criteria
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)
Intervention
Intervention Type
Intervention Name
DRUG
Dexmedetomidine
DRUG
Acetaminophen
DRUG
Ketorolac
DRUG
Morphine
Phase
NA
Gender
ALL
Min Age
3 Years
Max Age
17 Years
Download Date
2024-05-14
Principal Investigator
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
jocelyn.booth@childrens.harvard.edu
Samuel Kim, BS
samuel.kim@childrens.harvard.edu
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: