Postoperative Nausea and Vomiting and Acupuncture/Acupressure

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965367
• Other study ID #: 125/2007
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 24, 2009
• Last updated: August 24, 2009
• Start date: May 2008
• Est. completion date: November 2008

Study information

• Verified date: August 2009
• Source: National Research Centre of Complementary and Alternative Medicine, Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Postoperative Vomiting
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
Norway	Lovisenberg Diaconale Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
National Research Centre of Complementary and Alternative Medicine, Norway	Lovisenberg Diaconale Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative nausea and vomiting		24 hours	No
Secondary	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.		24 hours	No