Clinical trial NCT01729052: Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes
Official title: The Effect of Acupuncture for Alleviation of Postoperative Nausea, Vomiting, and Pain in Children: The Implications of Parental Attitudes and Expectations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Postoperative Pain
Keywords: Acupuncture
Children
Postoperative nausea and vomiting
Postoperative pain
Parental attitudes
Parental expectations
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: Norwegian Foundation for Health and Rehabilitation
First posted: 2012-11-20
Enrollment: 282
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative nausea Postoperative vomiting Postoperative pain
timeFrame: Within 24 hours postoperatively
Secondary outcomes:
Other outcomes:
measure: Parental attitudes Parental expectations
timeFrame: Within 24 hours postoperatively
Locations:
Study officials:
affiliation: NAFKAM, UiT
name: Arne Johan Norheim, dr.phil.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liodden I, Pripp AH, Norheim AJ. Placebo by proxy expectations toward acupuncture change over time: a survey comparing parental expectations to acupuncture pre- and postoperatively. BMC Complement Altern Med. 2018 Jun 14;18(1):183. doi: 10.1186/s12906-018-2248-z.
citation: Liodden I, Sandvik L, Norheim AJ. Placebo by Proxy--the Influence of Parental Anxiety and Expectancy on Postoperative Morbidities in Children. Forsch Komplementmed. 2015;22(6):381-7. doi: 10.1159/000442565. Epub 2015 Dec 7.
citation: Liodden I, Sandvik L, Valeberg BT, Borud E, Norheim AJ. Acupuncture versus usual care for postoperative nausea and vomiting in children after tonsillectomy/adenoidectomy: a pragmatic, multicentre, double-blinded, randomised trial. Acupunct Med. 2015 Jun;33(3):196-203. doi: 10.1136/acupmed-2014-010738. Epub 2015 Apr 13.