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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01729052
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : September 19, 2013
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
University of Tromso

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

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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

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01729052

Sponsors and Collaborators
University of Tromso
Norwegian Foundation for Health and Rehabilitation
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Principal Investigator: Arne Johan Norheim, dr.phil. NAFKAM, UiT
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Tromso Identifier: NCT01729052    
Other Study ID Numbers: 2012/631
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013
Keywords provided by University of Tromso:
Postoperative nausea and vomiting
Postoperative pain
Parental attitudes
Parental expectations
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms, Digestive