Clinical Trials Directory

Trials / Completed

CompletedNCT00965367

Postoperative Nausea and Vomiting and Acupuncture/Acupressure

Can Acustimulation Attenuate Postoperative Nausea and Vomiting in Children Who Have Undergone Tonsillectomy/Adenoidectomy?

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
154 (actual)
Sponsor
National Research Centre of Complementary and Alternative Medicine, Norway · Academic / Other
Sex
All
Age
2 Years – 12 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEAcustimulationAcupressure in P6 bilaterally given after induction of anaesthesia for 20 minutes, followed by acupressure wrist bands applied on the same acupoints for 24 hours.

Timeline

Start date
2008-05-01
Primary completion
2008-11-01
Completion
2008-11-01
First posted
2009-08-25
Last updated
2009-08-25

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT00965367. Inclusion in this directory is not an endorsement.