NCT01729052

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

  • 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

7 months

First QC Date

November 13, 2012

Last Update Submit

September 18, 2013

Conditions

Postoperative Nausea and VomitingPostoperative Pain

Keywords

AcupunctureChildrenPostoperative nausea and vomitingPostoperative painParental attitudesParental expectations

Outcome Measures

Primary Outcomes (1)

  • Postoperative nausea Postoperative vomiting Postoperative pain

    Within 24 hours postoperatively

Other Outcomes (1)

  • Parental attitudes Parental expectations

    Within 24 hours postoperatively

Study Arms (2)

Acupuncture and standard treatment

EXPERIMENTAL

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

Standard treatment

NO INTERVENTION

General anaesthesia

Interventions

AcupunctureDEVICE
Acupuncture and standard treatment

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children from two to eleven years of age
  • Children scheduled for tonsillectomy and/or adenoidectomy
  • Informed consent from the parents

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 29898710DERIVED

  • 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.

    PMID: 26840420DERIVED

  • 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.

    PMID: 25870177DERIVED

MeSH Terms

Conditions

Postoperative Nausea and VomitingPain, Postoperative

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomitingPainNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Arne Johan Norheim, dr.phil.

    NAFKAM, UiT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2012

First Posted

November 20, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 19, 2013

Record last verified: 2013-09