NCT Number: NCT01729052
Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes
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
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Notify MeKey information
Conditions
Age range
2 year–11 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Postoperative nausea Postoperative vomiting Postoperative pain
Time frame: Within 24 hours postoperatively
Other outcomes
-
Parental attitudes Parental expectations
Time frame: Within 24 hours postoperatively
Sponsors and collaborators
Lead sponsor
University of Tromso
Other
Collaborators
- Norwegian Foundation for Health and Rehabilitation
Registry information
Official study title
The Effect of Acupuncture for Alleviation of Postoperative Nausea, Vomiting, and Pain in Children: The Implications of Parental Attitudes and Expectations
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Nov 20, 2012
- Registry last updated
- Sep 19, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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