Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes
NCT ID: NCT01729052
Last Updated: 2013-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
282 participants
INTERVENTIONAL
2012-11-30
2013-06-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Acupuncture
Standard treatment
General anaesthesia
No interventions assigned to this group
Interventions
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Acupuncture
Eligibility Criteria
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Inclusion Criteria
* Children scheduled for tonsillectomy and/or adenoidectomy
* Informed consent from the parents
Exclusion Criteria
* 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
2 Years
11 Years
ALL
No
Sponsors
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Norwegian Foundation for Health and Rehabilitation
OTHER
University of Tromso
OTHER
Responsible Party
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Principal Investigators
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Arne Johan Norheim, dr.phil.
Role: PRINCIPAL_INVESTIGATOR
NAFKAM, UiT
References
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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.
Other Identifiers
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2012/631
Identifier Type: -
Identifier Source: org_study_id