Trial Outcomes & Findings for Acupuncture and Nausea/Vomiting in Pediatric Patients (NCT NCT01417741)

Results Overview

Post operative Nausea and vomiting in phase 1 and 11 recovery (Measured as a percentage of participants who experienced this outcome) Post op Nausea and vomiting on post op day one ( measured as a percentage of participants who experienced this outcome) as reported on a telephone survey

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

164 participants

Primary outcome timeframe

24 hours

Results posted on

2019-08-28

Participant Flow

randomization of three patients unrecorded, so 161 properly randomized patients were entered in study

Participant milestones

Participant milestones
Measure	Standard Therapy Only Patients will not receive acupuncture. Standard anti-emetic therapy will be given. Standard anti -emetic therapy at our institution for children having a T and A consists of Ondansetron 0.15 mg/kg and dexamethasone 0.25mg/kg up to 10 mg.	Acupuncture Plus Standard Therapy Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy. Acupuncture Needle: A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist
Overall Study STARTED	75	86
Overall Study COMPLETED	75	86
Overall Study NOT COMPLETED	0	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	Standard Therapy Only n=75 Participants Patients will not receive acupuncture. Standard anti-emetic therapy will be given. Children ages 3-9 undergoing tonsillectomy with or without adenoidectomy were the population studied in both arms.	Acupuncture Plus Standard Therapy n=86 Participants Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy. Acupuncture Needle: A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist	Total n=161 Participants Total of all reporting groups
Age, Continuous Mean Age	5.5 years STANDARD_DEVIATION 1.8 • n=75 Participants	5.2 years STANDARD_DEVIATION 1.9 • n=86 Participants	5.3 years STANDARD_DEVIATION 1.9 • n=161 Participants
Sex: Female, Male Female	33 Participants n=75 Participants	45 Participants n=86 Participants	78 Participants n=161 Participants
Sex: Female, Male Male	42 Participants n=75 Participants	41 Participants n=86 Participants	83 Participants n=161 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	75 participants n=75 Participants	86 participants n=86 Participants	161 participants n=161 Participants

PRIMARY outcome

Timeframe: 24 hours

Post operative Nausea and vomiting in phase 1 and 11 recovery (Measured as a percentage of participants who experienced this outcome) Post op Nausea and vomiting on post op day one ( measured as a percentage of participants who experienced this outcome) as reported on a telephone survey

Outcome measures

Outcome measures
Measure	Standard Therapy Only n=75 Participants Patients will not receive acupuncture. Standard anti-emetic therapy will be given. In phase i and 11 recovery units 26 patients ( 34.7 %) of 75 patients in this arm experienced Nausea and or vomiting. on POD 1; 37 patients or 54% experienced nausea or vomiting	Acupuncture Plus Standard Therapy n=86 Participants Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy. Acupuncture Needle: A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist In phase 1 and 11 recovery units: 6 patients ( 7%) of 86 experienced nausea or vomiting On POD one: 31 or 43% experienced PONV
Postoperative Nausea and Vomiting Immediate Post Op	26 Participants	6 Participants
Postoperative Nausea and Vomiting Post Op Day 1	37 Participants	31 Participants

Adverse Events

Standard Therapy Only ( AE Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acupuncture Plus Standard Therapy

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

Dr. Christine Martin, assistant professor

OHSU department of APOM

Phone: 503 494 7641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place