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Postoperative Nausea and Vomiting and Acupuncture/Acupressure

NCT00965367 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2009-08-25

No results posted yet for this study

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.

Conditions

  • Postoperative Vomiting
  • Nausea

Interventions

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.

Sponsors & Collaborators

  • Lovisenberg Diaconale Hospital

    collaborator UNKNOWN

  • National Research Centre of Complementary and Alternative Medicine, Norway

    lead OTHER

Principal Investigators

  • Arne Johan Norheim, MD Doctor phD · National Research Centre of Complementary and Alternative Medicine, Norway

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00965367 on ClinicalTrials.gov