Postoperative Vomiting and Nausea
Conditions
Brief summary
The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus standard therapy on postoperative nausea and vomiting in pediatric patients undergoing tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either the treatment or the control group. 1. Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the induction of anesthesia 2. Control Group: Standard anti-emetic therapy only This study will monitor nausea, retching, and vomiting events both directly after the surgery as well as the next day via a follow-up phone call to the parents of the study participant.
Interventions
DEVICEAcupuncture Needle
A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* ASA 1 to 3 physical status * Undergoing Tonsillectomy and/or adenoidectomy * Consent obtained from Parent/Guardian
Exclusion criteria
* Taking preoperative steroids, including inhalers * Taking baseline anti-emetics * History of motion sickness * BMI \> 35 (morbid obesity) * Severe OSA (Apnea/hypopnea Index \> 10) * Have genetic abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Nausea and Vomiting | 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 |
Countries
United States
Participant flow
Recruitment details
randomization of three patients unrecorded, so 161 properly randomized patients were entered in study
Participants by arm
| Arm | Count |
|---|---|
| Standard Therapy Only 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. | 75 |
| 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 | 86 |
| Total | 161 |
Baseline characteristics
| Characteristic | Acupuncture Plus Standard Therapy | Total | Standard Therapy Only |
|---|---|---|---|
| Age, Continuous Mean Age | 5.2 years STANDARD_DEVIATION 1.9 | 5.3 years STANDARD_DEVIATION 1.9 | 5.5 years STANDARD_DEVIATION 1.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 86 participants | 161 participants | 75 participants |
| Sex: Female, Male Female | 45 Participants | 78 Participants | 33 Participants |
| Sex: Female, Male Male | 41 Participants | 83 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 86 |
| other Total, other adverse events | 0 / 75 | 0 / 86 |
| serious Total, serious adverse events | 0 / 75 | 0 / 86 |
Outcome results
Primary
Postoperative Nausea and Vomiting
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
Time frame: 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Therapy Only | Postoperative Nausea and Vomiting | Immediate Post Op | 26 Participants |
| Standard Therapy Only | Postoperative Nausea and Vomiting | Post Op Day 1 | 37 Participants |
| Acupuncture Plus Standard Therapy | Postoperative Nausea and Vomiting | Post Op Day 1 | 31 Participants |
| Acupuncture Plus Standard Therapy | Postoperative Nausea and Vomiting | Immediate Post Op | 6 Participants |