Prospective randomized controlled trial to determine if opioid-free anesthetic for tonsillectomy is non-inferior to standard opioid-containing anesthetic
Objectives: Primary: To determine if an opioid-free anesthetic provides equivalent acute postoperative pain relief in tonsillectomy. Secondary: To determine if post-operative pain at home is not significantly different with an opioid-free regimen compared to an opioid containing regimen for tonsillectomy. Study Design: Prospective, randomized, multi-center trial study Study Interventions and Measures: Subject will be randomized to 1:1 intra-operative opioid-free (OFG) vs traditional care anesthetic with opioids (TCG) group The primary endpoint is the median pain score (calculated by a blinded validated observer in the recovery room at two time intervals) between the two cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
35
Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.
Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Tennessee Health Science Center; St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score
Mean FLACC pain assessment scores are calculated 15 and 30 minutes after awakening, Scores are calculated by a blinded study team observer. Minimum Score: 0 and Maximum Score: 10. Higher scores indicate worse outcomes. One Nursing Maximum FLACC pain score is obtained by an unblinded patient Registered Nurse (RN) during the patient's Post-Anesthesia Care Unit (PACU) stay within one hour of awakening. The pain score is collected from the nursing documentation in the electronic medical record. FLACC Minimum Score: 0 and Maximum Score: 10 Higher scores indicate worse outcomes.
Time frame: up to 1 hour
Number of Participants With Nausea, Vomiting, Pruritis
Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30.
Time frame: up to post-op day 30
Number of Participants Who Sought Unplanned Medical Attention
Number of participants who were readmitted to the hospital and sought unplanned medical attention (phone calls, office visits, emergency department visits) by chart review and questionnaires for readmission and medical reattendance, including calls to physician
Time frame: up to post-op day 30
Number of Participants Who Were Readmitted to the the Hospital
Number of participants who were readmitted to the hospital by chart review and questionnaires for readmission and medical reattendance, including calls to physician.
Time frame: Up to post-op day 30
Number of Participants With Non-artefactual Percentage of Oxygen Saturation (SpO2)<90% (>30 Seconds)
Number of participants with non-artefactual percentage of oxygen saturation (SpO2) less than 90% for greater than 30 seconds). Collected in the recovery room and chart review
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Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.
Time frame: up to post-op day 30
Number of Patients Receiving Rescue Opioids
How many subjects received rescue opioids after surgery
Time frame: up to post-op day 30
Family Satisfaction With Patient Recovery Based on Five-point Likert Score
Follow-up questionnaire to family on post-op days 1, 5, and 30. Parents will be asked to rank how satisfied they are with their child's recovery by using these two prompts: "I am satisfied with my child's recovery," and "I am satisfied with my child's pain control at home." They will choose from the following options: "Strongly agree = 1", "Agree = 2", "Undecided = 3", "Disagree = 4", "Strongly Disagree =5." Minimum score is 1, Max is 5. Higher scores indicate worse outcomes. Data assessed at post-op days 1, 5, and 30 were averaged.
Time frame: assessed at post-op days 1, 5, and 30
Number of Participants That Experienced Any Post-operative Bleeding Throughout the Study
Follow-up questionnaires administered on post-operative day 1, 5, ad 30 and chart review. Question: Has your child had any bright red blood in their mouth? Answer options: Yes/No
Time frame: up to post-op day 30