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Acupuncture and Nausea/Vomiting in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT01417741
Recruitment Status : Unknown
Verified April 2014 by Angela Kendrick, Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : August 16, 2011
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Angela Kendrick, Oregon Health and Science University

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.


Condition or disease Intervention/treatment Phase
Postoperative Vomiting and Nausea Device: Acupuncture Needle Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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?
Study Start Date : August 2011
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Postoperative Nausea and Vomiting [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Angela Kendrick, associate professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01417741     History of Changes
Other Study ID Numbers: APOM-7605
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes