Trial Outcomes & Findings for A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients (NCT NCT03714919)

Results Overview

Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

1 hr post-op

Results posted on

2021-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Non-opiod Pain Relief Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine. Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg Acetaminophen: Preoperative oral acetaminophen 15 mg/kg Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-opiod Pain Relief n=10 Participants Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine. Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg Acetaminophen: Preoperative oral acetaminophen 15 mg/kg Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg
ASA 1	6 participants n=10 Participants
ASA 2	4 participants n=10 Participants
Age, Categorical <=18 years	10 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Age, Continuous	5 years n=10 Participants
Sex: Female, Male Female	5 Participants n=10 Participants
Sex: Female, Male Male	5 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants
Weight	20.5 kilograms n=10 Participants
Height	110 centimeters n=10 Participants

PRIMARY outcome

Timeframe: 1 hr post-op

Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU).

Outcome measures

Outcome measures
Measure	Non-opiod Pain Relief n=10 Participants Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine. Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg Acetaminophen: Preoperative oral acetaminophen 15 mg/kg Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg
Average Pain Score	0 pain score Standard Deviation 0

SECONDARY outcome

Timeframe: 1 hr post-op

Amount of time in the PACU before patient is ready to be extubated.

Outcome measures

Outcome measures
Measure	Non-opiod Pain Relief n=10 Participants Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine. Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg Acetaminophen: Preoperative oral acetaminophen 15 mg/kg Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg
Extubation Time	23 minutes Interval 17.0 to 29.0

SECONDARY outcome

Timeframe: 1-2 hr post-op

Total time in PACU before patient met discharge criteria.

Outcome measures

Outcome measures
Measure	Non-opiod Pain Relief n=10 Participants Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine. Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg Acetaminophen: Preoperative oral acetaminophen 15 mg/kg Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg
Time in PACU	56 minutes Interval 49.0 to 65.0

SECONDARY outcome

Timeframe: 2 hours post-op

Presence of sedation, nausea/vomiting, or hallucinations post-operatively.

Outcome measures

Outcome measures
Measure	Non-opiod Pain Relief n=10 Participants Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine. Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg Acetaminophen: Preoperative oral acetaminophen 15 mg/kg Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg
Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations Sedation	7 participants
Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations Nausea/Vomiting	1 participants
Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations Hallucinations	0 participants

SECONDARY outcome

Timeframe: 2-3 hours post-op

Length of time before patient is ready to be discharged home.

Outcome measures

Outcome measures
Measure	Non-opiod Pain Relief n=10 Participants Subjects will receive preoperative oral dextromethorphan \& acetaminophen and intraoperative intravenous dexmedetomidine \& ketamine. Dextromethorphan: Preoperative oral dextromethorphan 1 mg/kg Acetaminophen: Preoperative oral acetaminophen 15 mg/kg Dexmedetomidine: Intraoperative intravenous dexmedetomidine 0.5 μg/kg Ketamine: Intraoperative intravenous ketamine 0.5 mg/kg
End of Surgery to Hospital Discharge	122 minutes Interval 106.0 to 187.0

Adverse Events

Non-opiod Pain Relief

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Arlyne Thung, MD

Nationwide Children's Hospital

Phone: 614-722-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place