Clinical trial NCT00965367: Postoperative Nausea and Vomiting and Acupuncture/Acupressure
Official title: Can Acustimulation Attenuate Postoperative Nausea and Vomiting in Children Who Have Undergone Tonsillectomy/Adenoidectomy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Vomiting
Nausea
Keywords: POV tonsillectomy adenoidectomy acupuncture acupressure child
Effectiveness of acupuncture on
Lead sponsor: National Research Centre of Complementary and Alternative Medicine, Norway
Sponsor class: OTHER
Collaborators: name: Lovisenberg Diaconale Hospital
First posted: 2009-08-25
Enrollment: 154
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Postoperative nausea and vomiting (PONV) remain a significant challenge in the investigators practice. However, pharmaceutical prophylaxis can imply unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and the adverse effects are minimal.

Consequently, the investigators will investigate if acupuncture and acupressure can be implemented as a supplementary to the ordinary treatment in children undergoing surgery for tonsillectomy and/or adenoidectomy. The study will also focus on the feasibility for acupuncture and acupressure in the operation theatre. The study and inclusion/exclusion decisions are conducted after the "intention-to-treat" principle. 126 patients are included, divided into two groups:

1. Treatment Group - standard treatment and acupuncture performed after induction of anaesthesia, acupressure administered before awakening
2. Control Group - standard treatment

The primarily endpoints in this study are nausea, retching and vomiting. The effect of acupuncture/acupressure 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 effects from the acupuncture site and wristband will be registered.


Eligibility criteria: Inclusion Criteria:

* Children scheduled for tonsillectomy and/or adenoidectomy
* Informed consent from the parents/guardians

Exclusion Criteria:

* ASA grade greater than or equal to III (patients with severe systemic disease)
* Rash or local infection over an acupuncture point
* Emesis during the previous 24 hours
* Use of medication with antiemetic effect and/or other antiemetic therapy within the 24 hours before surgery
* Gastric or intestinal diseases

Primary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
Secondary outcomes:
measure: The effect of the intervention will be studied with regard to any association with possible factors of predisposition to PONV. Adverse effects will also be registered.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diaconale Hospital
Study officials:
affiliation: National Research Centre of Complementary and Alternative Medicine, Norway
name: Arne Johan Norheim, MD Doctor phD
role: PRINCIPAL_INVESTIGATOR
References: