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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01729052
Enrollment
282
Registered
2012-11-20
Start date
2012-11-30
Completion date
2013-06-30
Last updated
2013-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting, Postoperative Pain

Keywords

Acupuncture, Children, Postoperative nausea and vomiting, Postoperative pain, Parental attitudes, Parental expectations

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

Interventions

DEVICEAcupuncture

Sponsors

Norwegian Foundation for Health and Rehabilitation
CollaboratorOTHER
University of Tromso
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Postoperative nausea Postoperative vomiting Postoperative painWithin 24 hours postoperatively

Other

MeasureTime frame
Parental attitudes Parental expectationsWithin 24 hours postoperatively

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026