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Postoperative Nausea and Vomiting and Acupuncture/Acupressure

This study has been completed.
Sponsor:
Collaborator:
Lovisenberg Diaconale Hospital
Information provided by:
National Research Centre of Complementary and Alternative Medicine, Norway
ClinicalTrials.gov Identifier:
NCT00965367
First received: August 24, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

Postoperative nausea and vomiting (PONV) remain a significant challenge in the investigators practice. However, pharmaceutical prophylaxis can imply unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and the adverse effects are minimal.

Consequently, the investigators will investigate if acupuncture and acupressure can be implemented as a supplementary to the ordinary treatment in children undergoing surgery for tonsillectomy and/or adenoidectomy. The study will also focus on the feasibility for acupuncture and acupressure in the operation theatre. The study and inclusion/exclusion decisions are conducted after the "intention-to-treat" principle. 126 patients are included, divided into two groups:

  1. Treatment Group - standard treatment and acupuncture performed after induction of anaesthesia, acupressure administered before awakening
  2. Control Group - standard treatment

The primarily endpoints in this study are nausea, retching and vomiting. The effect of acupuncture/acupressure will be studied with regard to any association with possible factors of predisposition to PONV, as well as with other factors registered during the study. Adverse effects from the acupuncture site and wristband will be registered.


Condition Intervention Phase
Postoperative Vomiting
Nausea
 Device: Acustimulation
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Can Acustimulation Attenuate Postoperative Nausea and Vomiting in Children Who Have Undergone Tonsillectomy/Adenoidectomy?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Research Centre of Complementary and Alternative Medicine, Norway:

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

Secondary Outcome Measures:
  • The effect of the intervention will be studied with regard to any association with possible factors of predisposition to PONV. Adverse effects will also be registered. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 154
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acustimulation Device: Acustimulation
Acupressure in P6 bilaterally given after induction of anaesthesia for 20 minutes, followed by acupressure wrist bands applied on the same acupoints for 24 hours.
No Intervention: Standard treatment group Device: Acustimulation
Acupressure in P6 bilaterally given after induction of anaesthesia for 20 minutes, followed by acupressure wrist bands applied on the same acupoints for 24 hours.

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children scheduled for tonsillectomy and/or adenoidectomy
  • Informed consent from the parents/guardians

Exclusion Criteria:

  • ASA grade greater than or equal to III (patients with severe systemic disease)
  • Rash or local infection over an acupuncture point
  • Emesis during the previous 24 hours
  • Use of medication with antiemetic effect and/or other antiemetic therapy within the 24 hours before surgery
  • Gastric or intestinal diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965367

Locations
Norway
Lovisenberg Diaconale Hospital
Oslo, Norway
Sponsors and Collaborators
National Research Centre of Complementary and Alternative Medicine, Norway
Lovisenberg Diaconale Hospital
Investigators
Principal Investigator: Arne Johan Norheim, MD Doctor phD National Research Centre of Complementary and Alternative Medicine, Norway
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00965367     History of Changes
Other Study ID Numbers: 125/2007
Study First Received: August 24, 2009
Last Updated: August 24, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by National Research Centre of Complementary and Alternative Medicine, Norway:
POV tonsillectomy adenoidectomy acupuncture acupressure child
Effectiveness of acupuncture on

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

ClinicalTrials.gov processed this record on May 16, 2013