Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery
- Conditions
- PainEmergence DeliriumAnesthesiaTonsillitisPost-operative Nausea and Vomiting (PONV)Opioid Analgesic Adverse Reaction
- Interventions
- Registration Number
- NCT06326983
- Lead Sponsor
- Boston Children's Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 58
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Opioid-Sparing Anesthetic Plan Dexmedetomidine For their tonsil surgery, subjects will receive Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg given intravenously at the end of surgery. No opioids will be given during the procedure. Opioid-Sparing Anesthetic Plan Acetaminophen For their tonsil surgery, subjects will receive Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg given intravenously at the end of surgery. No opioids will be given during the procedure. Opioid-Sparing Anesthetic Plan Ketorolac For their tonsil surgery, subjects will receive Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg given intravenously at the end of surgery. No opioids will be given during the procedure. Opioid Anesthetic Plan Acetaminophen For their tonsil surgery, subjects will receive Morphine (0.1mg/kg given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery. Opioid Anesthetic Plan Ketorolac For their tonsil surgery, subjects will receive Morphine (0.1mg/kg given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery. Opioid Anesthetic Plan Morphine For their tonsil surgery, subjects will receive Morphine (0.1mg/kg given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
- Primary Outcome Measures
Name Time Method Post Operative Anesthesia Unit Length of Stay (hours) 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
Median Pain Scores in the Post-Anesthesia Care Unit 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.
Post-operative pain at 12-24 hours 12-24 hours post-operatively Pain categorized as none, mild, moderate, and severe. Taken from the routine follow-up nursing phone call.
- Secondary Outcome Measures
Name Time Method Intraoperative Blood pressure (mmHg) 10 minutes Range of systolic blood pressure within 10 minutes of anesthesia induction
Opioid rescue medication administration surgery end to 2-6 hours post-operatively Opioid rescue medications administered (reported as oral morphine equivalents)
Procedure length (minutes) 0-60 minutes from incision time to patient being wheeled out of the operating room
Intraoperative Heart rate (beats per second) 10 minutes Range of heart rate within 10 minutes of anesthesia induction
Emergence Delirium 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.
Post-operative nausea and vomiting surgery end to 2-6 hours post-operatively Incidence of episodes of emesis or administration of anti-emetics in the post-anesthesia care unit
Vasopressor administration 0-60 minutes Intraoperative administration of vasopressors
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Waltham, Massachusetts, United States