Acupuncture and Nausea/Vomiting in Pediatric Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Angela Kendrick, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01417741
First received: August 15, 2011
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Postoperative Vomiting and Nausea
Device: Acupuncture Needle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Is Intra-operative Acupuncture at P6 Plus IV Antiemetics More Effective Than IV Antiemetic Therapy Alone in Preventing Postoperative Vomiting in Pediatric Patients Following Tonsillectomy With or Without Adenoidectomy?

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Postoperative Nausea and Vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Therapy Only
Patients will not receive acupuncture. Standard anti-emetic therapy will be given.
Experimental: 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.
Device: Acupuncture Needle
A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist
Other Name: Seirin Pyonex

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417741

Contacts
Contact: Angela Kendrick, MD 503-494-4919 Kendrick@ohsu.edu

Locations
United States, Oregon
Oregon Health and Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Angela Kendrick, MD    503-494-4919    kendrick@ohsu.edu   
Principal Investigator: Angela Kendrick, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Angela Kendrick, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Angela Kendrick, associate professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01417741     History of Changes
Other Study ID Numbers: APOM-7605
Study First Received: August 15, 2011
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 21, 2014