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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Postoperative Nausea and Vomiting
• Intervention / Treatment: Device: Acupuncture

• Study Type: Interventional
• Enrollment (Actual): 282
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: Acupuncture
No Intervention: Standard treatment; General anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative nausea Postoperative vomiting Postoperative pain	Within 24 hours postoperatively

Other Outcome Measures

Outcome Measure	Time Frame
Parental attitudes Parental expectations	Within 24 hours postoperatively

Collaborators and Investigators

• Sponsor: University of Tromso
• Collaborators: Norwegian Foundation for Health and Rehabilitation
• Investigators: Principal Investigator: Arne Johan Norheim, dr.phil., NAFKAM, UiT

Publications and helpful links

General Publications

• Liodden I, Pripp AH, Norheim AJ. Placebo by proxy expectations toward acupuncture change over time: a survey comparing parental expectations to acupuncture pre- and postoperatively. BMC Complement Altern Med. 2018 Jun 14;18(1):183. doi: 10.1186/s12906-018-2248-z.
• Liodden I, Sandvik L, Norheim AJ. Placebo by Proxy--the Influence of Parental Anxiety and Expectancy on Postoperative Morbidities in Children. Forsch Komplementmed. 2015;22(6):381-7. doi: 10.1159/000442565. Epub 2015 Dec 7.
• Liodden I, Sandvik L, Valeberg BT, Borud E, Norheim AJ. Acupuncture versus usual care for postoperative nausea and vomiting in children after tonsillectomy/adenoidectomy: a pragmatic, multicentre, double-blinded, randomised trial. Acupunct Med. 2015 Jun;33(3):196-203. doi: 10.1136/acupmed-2014-010738. Epub 2015 Apr 13.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 13, 2012
• First Submitted That Met QC Criteria: November 13, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Estimate): September 19, 2013
• Last Update Submitted That Met QC Criteria: September 18, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Acupuncture; Children; Postoperative nausea and vomiting; Postoperative pain; Parental attitudes; Parental expectations
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 2012/631