Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes
Primary Purpose
Postoperative Nausea and Vomiting, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Acupuncture, Children, Postoperative nausea and vomiting, Postoperative pain, Parental attitudes, Parental expectations
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acupuncture and standard treatment
Standard treatment
Arm 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
General anaesthesia
Outcomes
Primary Outcome Measures
Postoperative nausea Postoperative vomiting Postoperative pain
Secondary Outcome Measures
Full Information
NCT ID
NCT01729052
First Posted
November 13, 2012
Last Updated
September 18, 2013
Sponsor
University of Tromso
Collaborators
Norwegian Foundation for Health and Rehabilitation
1. Study Identification
Unique Protocol Identification Number
NCT01729052
Brief Title
Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes
Official Title
The Effect of Acupuncture for Alleviation of Postoperative Nausea, Vomiting, and Pain in Children: The Implications of Parental Attitudes and Expectations
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tromso
Collaborators
Norwegian Foundation for Health and Rehabilitation
4. Oversight
Data Monitoring Committee
No
5. 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
Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during anaesthesia and standard treatment
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Postoperative Pain
Keywords
Acupuncture, Children, Postoperative nausea and vomiting, Postoperative pain, Parental attitudes, Parental expectations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture and standard treatment
Arm Type
Experimental
Arm 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
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
General anaesthesia
Intervention Type
Device
Intervention Name(s)
Acupuncture
Primary Outcome Measure Information:
Title
Postoperative nausea Postoperative vomiting Postoperative pain
Time Frame
Within 24 hours postoperatively
Other Pre-specified Outcome Measures:
Title
Parental attitudes Parental expectations
Time Frame
Within 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Johan Norheim, dr.phil.
Organizational Affiliation
NAFKAM, UiT
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
29898710
Citation
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.
Results Reference
derived
PubMed Identifier
26840420
Citation
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.
Results Reference
derived
PubMed Identifier
25870177
Citation
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.
Results Reference
derived
Learn more about this trial
Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes
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