Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes

Postoperative Pain Clinical Trial

Official title:

The Effect of Acupuncture for Alleviation of Postoperative Nausea, Vomiting, and Pain in Children: The Implications of Parental Attitudes and Expectations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729052
• Other study ID #: 2012/631
• Status: Completed
• Phase: N/A
• First received: November 13, 2012
• Last updated: September 18, 2013
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Data Protection AuthorityNorway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice. However, pharmaceutical prophylaxis is only partially effective and can imply unpleasant adverse effects. Accordingly, the use of non-pharmacological methods in preventing PONV is appropriate. Acupuncture is reported to reduce PONV and pain, and the adverse events are minimal.

The objective of this multicentre, double-blinded, randomized, controlled trial is to investigate whether acupuncture can be a supplementary to the ordinary treatment in children undergoing tonsillectomy and/or adenoidectomy. In addition, the non-specific effect of parental attitudes and expectations on the outcomes will be explored.

Two hundred and eighty patients will be included and randomized into two groups

1. Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during anaesthesia and standard treatment

2. Control group: standard treatment

The primary endpoints in the intervention study are nausea, retching, vomiting and pain during 24 hours postoperatively. The effect of acupuncture 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 events from acupuncture will be registered.

The objective of the self-report questionnaires is to

• investigate parental attitudes and expectations to the acupuncture treatment pre- and postoperatively

• compare data of the outcomes from the intervention trial with data from the questionnaires, in order to find any correlation between parental beliefs, attitudes and expectations, and the effect of the acupuncture treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

Inclusion Criteria:

• Children from two to eleven years of age

• Children scheduled for tonsillectomy and/or adenoidectomy

• Informed consent from the parents

Exclusion Criteria:

• American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease)

• Patients/parents in need of an interpreter

• Rash or local infection over an acupuncture point

• Emesis during the previous 24 hours

• Use of medication with antiemetic effect within the 24 hours before surgery

• Gastric or intestinal diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vomiting

Intervention

Device:
• Acupuncture

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Tromso	Norwegian Foundation for Health and Rehabilitation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental attitudes Parental expectations		Within 24 hours postoperatively	No
Primary	Postoperative nausea Postoperative vomiting Postoperative pain		Within 24 hours postoperatively	No