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

University of Tromso (UiT)

Status: Completed

Conditions: Postoperative Pain; Postoperative Nausea and Vomiting

Treatments: Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01729052

2012/631

Details and patient eligibility

About

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

Enrollment: 282 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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282 participants in 2 patient groups

Acupuncture and standard treatment

Experimental group

Description:

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

Treatment:

Device: Acupuncture

Standard treatment

No Intervention group

Description:

General anaesthesia