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Postoperative Nausea and Vomiting and Acupuncture/Acupressure

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ClinicalTrials.gov Identifier: NCT00965367
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : August 25, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Postoperative Vomiting Nausea Device: Acustimulation Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Can Acustimulation Attenuate Postoperative Nausea and Vomiting in Children Who Have Undergone Tonsillectomy/Adenoidectomy?
Study Start Date : May 2008
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Postoperative nausea and vomiting [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

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): 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

ClinicalTrials.gov Identifier: NCT00965367     History of Changes
Other Study ID Numbers: 125/2007
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009

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