Back to resultsPostoperative Nausea and Vomiting and Acupuncture/Acupressure
Primary Purpose
Postoperative Vomiting, Nausea
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Acustimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Vomiting focused on measuring POV tonsillectomy adenoidectomy acupuncture acupressure child, Effectiveness of acupuncture on
Eligibility Criteria
Inclusion Criteria:
- Children scheduled for tonsillectomy and/or adenoidectomy
- Informed consent from the parents/guardians
Exclusion Criteria:
- ASA grade greater than or equal to III (patients with severe systemic disease)
- Rash or local infection over an acupuncture point
- Emesis during the previous 24 hours
- Use of medication with antiemetic effect and/or other antiemetic therapy within the 24 hours before surgery
- Gastric or intestinal diseases
Sites / Locations
- Lovisenberg Diaconale Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acustimulation
Standard treatment group
Arm Description
Outcomes
Primary Outcome Measures
Postoperative nausea and vomiting
Secondary Outcome Measures
The effect of the intervention will be studied with regard to any association with possible factors of predisposition to PONV. Adverse effects will also be registered.
Full Information
NCT ID
NCT00965367
First Posted
August 24, 2009
Last Updated
August 24, 2009
Sponsor
National Research Centre of Complementary and Alternative Medicine, Norway
Collaborators
Lovisenberg Diaconale Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00965367
Brief Title
Postoperative Nausea and Vomiting and Acupuncture/Acupressure
Official Title
Can Acustimulation Attenuate Postoperative Nausea and Vomiting in Children Who Have Undergone Tonsillectomy/Adenoidectomy?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Research Centre of Complementary and Alternative Medicine, Norway
Collaborators
Lovisenberg Diaconale Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Postoperative nausea and vomiting (PONV) remain a significant challenge in the investigators practice. However, pharmaceutical prophylaxis can imply unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and the adverse effects are minimal.
Consequently, the investigators will investigate if acupuncture and acupressure can be implemented as a supplementary to the ordinary treatment in children undergoing surgery for tonsillectomy and/or adenoidectomy. The study will also focus on the feasibility for acupuncture and acupressure in the operation theatre. The study and inclusion/exclusion decisions are conducted after the "intention-to-treat" principle. 126 patients are included, divided into two groups:
Treatment Group - standard treatment and acupuncture performed after induction of anaesthesia, acupressure administered before awakening
Control Group - standard treatment
The primarily endpoints in this study are nausea, retching and vomiting. The effect of acupuncture/acupressure 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 effects from the acupuncture site and wristband will be registered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Vomiting, Nausea
Keywords
POV tonsillectomy adenoidectomy acupuncture acupressure child, Effectiveness of acupuncture on
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acustimulation
Arm Type
Experimental
Arm Title
Standard treatment group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Acustimulation
Intervention Description
Acupressure in P6 bilaterally given after induction of anaesthesia for 20 minutes, followed by acupressure wrist bands applied on the same acupoints for 24 hours.
Primary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The effect of the intervention will be studied with regard to any association with possible factors of predisposition to PONV. Adverse effects will also be registered.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children scheduled for tonsillectomy and/or adenoidectomy
Informed consent from the parents/guardians
Exclusion Criteria:
ASA grade greater than or equal to III (patients with severe systemic disease)
Rash or local infection over an acupuncture point
Emesis during the previous 24 hours
Use of medication with antiemetic effect and/or other antiemetic therapy within the 24 hours before surgery
Gastric or intestinal diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Johan Norheim, MD Doctor phD
Organizational Affiliation
National Research Centre of Complementary and Alternative Medicine, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lovisenberg Diaconale Hospital
City
Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Postoperative Nausea and Vomiting and Acupuncture/Acupressure
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