Anesthesia, Emergence Delirium, Opioid Analgesic Adverse Reaction, Pain, Post-operative Nausea and Vomiting (PONV), Tonsillitis
Conditions
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia
DRUGAcetaminophen
Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia).
DRUGKetorolac
Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
DRUGMorphine
Morphine (0.1mg/kg given intravenously at induction of anesthesia)
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid rescue medication administration | surgery end to 2-6 hours post-operatively | Opioid rescue medications administered (reported as oral morphine equivalents) |
| 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 |
| Procedure length (minutes) | 0-60 minutes | from incision time to patient being wheeled out of the operating room |
| Intraoperative Blood pressure (mmHg) | 10 minutes | Range of systolic blood pressure within 10 minutes of anesthesia induction |
| Intraoperative Heart rate (beats per second) | 10 minutes | Range of heart rate within 10 minutes of anesthesia induction |
| Vasopressor administration | 0-60 minutes | Intraoperative administration of vasopressors |
Countries
United States
Outcome results
None listed