Trial Outcomes & Findings for Opioid-Free Anesthetic for Tonsillectomy (NCT NCT04528173)

NCT ID: NCT04528173

Last Updated: 2024-12-20

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 35 participants
• Primary outcome timeframe: up to 1 hour
• Results posted on: 2024-12-20

Participant Flow

Participant milestones

Measure	Traditional Care Group (TCG) Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Overall Study STARTED	18	17
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Opioid-Free Anesthetic for Tonsillectomy

Baseline characteristics by cohort

Measure	Traditional Care Group (TCG) n=18 Participants Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) n=17 Participants Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.	Total n=35 Participants Total of all reporting groups
Age, Customized	3.56 years n=5 Participants	6.47 years n=7 Participants	4.97 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 1 hour

Population: Nurse maximum pain score not documented for 2 subjects

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.

Outcome measures

Measure	Traditional Care Group (TCG) n=18 Participants Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) n=17 Participants Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score 15 minutes	3.56 score on a scale Standard Deviation 3.45	2.47 score on a scale Standard Deviation 3.04
Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score 30 minutes	2.28 score on a scale Standard Deviation 2.70	1.88 score on a scale Standard Deviation 2.67
Mean FLACC (Face, Legs, Activity, Cry, Consolability) Pain Score Nurse Max Score up to 1 hour	5.29 score on a scale Standard Deviation 4.30	5.69 score on a scale Standard Deviation 4.27

SECONDARY outcome

Timeframe: up to post-op day 30

Collected in recovery room and asked in questionnaires, collected from parents on post-operative days 1, 5, and 30.

Outcome measures

Measure	Traditional Care Group (TCG) n=18 Participants Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) n=17 Participants Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Number of Participants With Nausea, Vomiting, Pruritis Nausea	2 participants	1 participants
Number of Participants With Nausea, Vomiting, Pruritis Vomiting	2 participants	0 participants
Number of Participants With Nausea, Vomiting, Pruritis pruritis	0 participants	0 participants

SECONDARY outcome

Timeframe: up to post-op day 30

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

Outcome measures

Measure	Traditional Care Group (TCG) n=18 Participants Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) n=17 Participants Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Number of Participants Who Sought Unplanned Medical Attention	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to post-op day 30

Number of participants who were readmitted to the hospital by chart review and questionnaires for readmission and medical reattendance, including calls to physician.

Outcome measures

Measure	Traditional Care Group (TCG) n=18 Participants Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) n=17 Participants Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Number of Participants Who Were Readmitted to the the Hospital	1 Participants	0 Participants

SECONDARY outcome

Timeframe: up to post-op day 30

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

Outcome measures

Measure	Traditional Care Group (TCG) n=18 Participants Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) n=17 Participants Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Number of Participants With Non-artefactual Percentage of Oxygen Saturation (SpO2)<90% (>30 Seconds)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: up to post-op day 30

How many subjects received rescue opioids after surgery

Outcome measures

Measure	Traditional Care Group (TCG) n=18 Participants Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) n=17 Participants Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Number of Patients Receiving Rescue Opioids	9 Participants	11 Participants

SECONDARY outcome

Timeframe: assessed at post-op days 1, 5, and 30

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.

Outcome measures

Measure	Traditional Care Group (TCG) n=18 Participants Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) n=17 Participants Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Family Satisfaction With Patient Recovery Based on Five-point Likert Score Recovery Satisfaction	1.4 score on a scale Interval 1.0 to 3.0	1.3 score on a scale Interval 1.0 to 3.0
Family Satisfaction With Patient Recovery Based on Five-point Likert Score Pain Control Satisfaction	1.6 score on a scale Interval 1.0 to 4.0	1.5 score on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: up to post-op day 30

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

Outcome measures

Measure	Traditional Care Group (TCG) n=18 Participants Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) n=17 Participants Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Number of Participants That Experienced Any Post-operative Bleeding Throughout the Study	0 Participants	0 Participants

Adverse Events

Traditional Care Group (TCG)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Opioid-Free Group (OFG)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Traditional Care Group (TCG) n=18 participants at risk Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) n=17 participants at risk Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
General disorders Prolonged admission	5.6% 1/18 • Number of events 1 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov	0.00% 0/17 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov
General disorders Readmission	5.6% 1/18 • Number of events 1 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov	0.00% 0/17 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov
Surgical and medical procedures Bleeding Events	0.00% 0/18 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov	0.00% 0/17 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov

Other adverse events

Measure	Traditional Care Group (TCG) n=18 participants at risk Traditional anesthetic with opioids group will receive institutional standard clinical care for tonsillectomy, including a standardized opioid dose at the beginning of the case and again at the end if needed. Dexmedetomidine and Ketorolac will not be used intra-operatively in this cohort to prevent confounding. Morphine: Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care. Fentanyl: Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.	Opioid-Free Group (OFG) n=17 participants at risk Opioid-Free group will receive institutional standard clinical care for tonsillectomy, without opioids, but including Dexmedetomidine and Ketorolac. Ketorolac: Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis. Dexmedetomidine: Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
Respiratory, thoracic and mediastinal disorders Oxygen Desaturation	5.6% 1/18 • Number of events 1 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov	5.9% 1/17 • Number of events 1 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov
General disorders Dehydration	5.6% 1/18 • Number of events 1 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov	5.9% 1/17 • Number of events 1 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov
Gastrointestinal disorders Nausea/Vomiting	11.1% 2/18 • Number of events 2 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov	5.9% 1/17 • Number of events 1 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov
Surgical and medical procedures Emergency department encounter	5.6% 1/18 • Number of events 1 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov	23.5% 4/17 • Number of events 4 • Up to 30 days Definitions of adverse and/or serious adverse events do not differ from clinicaltrials.gov

Additional Information

Tori Nicole Sutherland MD MPH

The Children's Hospital of Philadelphia

Phone: 443-631-5032

Email: sutherlant@chop.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place