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

• ClinicalTrials.gov Identifier: NCT01729052
• Recruitment Status: Completed
• First Posted: November 20, 2012
• Last Update Posted: September 19, 2013
• Sponsor: University of Tromso
• Collaborator: Norwegian Foundation for Health and Rehabilitation
• Information provided by (Responsible Party): University of Tromso

Study Description

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

Condition or disease	Intervention/treatment	Phase
Postoperative Nausea and Vomiting; Postoperative Pain	Device: Acupuncture	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 282 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Acupuncture for Alleviation of Postoperative Nausea, Vomiting, and Pain in Children: The Implications of Parental Attitudes and Expectations
• Study Start Date: November 2012
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Postoperative nausea Postoperative vomiting Postoperative pain [ Time Frame: Within 24 hours postoperatively ]

Other Outcome Measures:

1. Parental attitudes Parental expectations [ Time Frame: Within 24 hours postoperatively ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

University of Tromso

Norwegian Foundation for Health and Rehabilitation

Investigators

• Principal Investigator: Arne Johan Norheim, dr.phil.; NAFKAM, UiT

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Tromso
• ClinicalTrials.gov Identifier: NCT01729052
• Other Study ID Numbers: 2012/631
• First Posted: November 20, 2012
• Last Update Posted: September 19, 2013
• Last Verified: September 2013

Keywords provided by University of Tromso:

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

Additional relevant MeSH terms:

Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive