Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes
|ClinicalTrials.gov Identifier: NCT01729052|
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : September 19, 2013
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
- Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during anaesthesia and standard treatment
- 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
|Condition or disease||Intervention/treatment|
|Postoperative Nausea and Vomiting Postoperative Pain||Device: Acupuncture|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Acupuncture for Alleviation of Postoperative Nausea, Vomiting, and Pain in Children: The Implications of Parental Attitudes and Expectations|
|Study Start Date :||November 2012|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
Experimental: Acupuncture and standard treatment
Acupuncture at Neiguan (Pericardium-6) bilaterally with Seirin needles no 3 (0.20x15 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed before they are fully awake.
Standard treatment: general anaesthesia
No Intervention: Standard treatment
- Postoperative nausea Postoperative vomiting Postoperative pain [ Time Frame: Within 24 hours postoperatively ]
- Parental attitudes Parental expectations [ Time Frame: Within 24 hours postoperatively ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729052
|Principal Investigator:||Arne Johan Norheim, dr.phil.||NAFKAM, UiT|