Postoperative Nausea and Vomiting and Acupuncture/Acupressure

NCT ID: NCT00965367

Last Updated: 2009-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-11-30

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.

Conditions

Postoperative Vomiting; Nausea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Acustimulation

Group Type: EXPERIMENTAL

Acustimulation

Intervention Type: DEVICE

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.

Standard treatment group

Group Type: NO_INTERVENTION

Acustimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lovisenberg Diaconale Hospital

UNKNOWN

Sponsor Role: collaborator

National Research Centre of Complementary and Alternative Medicine, Norway

OTHER

Sponsor Role: lead

Principal Investigators

Arne Johan Norheim, MD Doctor phD

Role: PRINCIPAL_INVESTIGATOR

National Research Centre of Complementary and Alternative Medicine, Norway

Locations

Lovisenberg Diaconale Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

125/2007

Identifier Type: -

Identifier Source: org_study_id