Postoperative Nausea and Vomiting and Acupuncture/Acupressure

National Research Centre of Complementary and Alternative Medicine, Norway

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nausea; Postoperative Vomiting

Treatments: Device: Acustimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00965367

125/2007

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Acustimulation

Experimental group

Treatment:

Device: Acustimulation

Standard treatment group

No Intervention group

Treatment:

Device: Acustimulation