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

This study has been completed.
Sponsor:
Collaborator:
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
University of Tromso
ClinicalTrials.gov Identifier:
NCT01729052
First received: November 13, 2012
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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 Intervention
Postoperative Nausea and Vomiting
Postoperative Pain
Device: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Tromso:

Primary Outcome Measures:
  • Postoperative nausea Postoperative vomiting Postoperative pain [ Time Frame: Within 24 hours postoperatively ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Parental attitudes Parental expectations [ Time Frame: Within 24 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 282
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729052

Sponsors and Collaborators
University of Tromso
Norwegian Foundation for Health and Rehabilitation
Investigators
Principal Investigator: Arne Johan Norheim, dr.phil. NAFKAM, UiT
  More Information

No publications provided

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT01729052     History of Changes
Other Study ID Numbers: 2012/631
Study First Received: November 13, 2012
Last Updated: September 18, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority
Norway: Directorate of Health

Keywords provided by University of Tromso:
Acupuncture
Children
Postoperative nausea and vomiting
Postoperative pain
Parental attitudes
Parental expectations

Additional relevant MeSH terms:
Nausea
Pain, Postoperative
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain

ClinicalTrials.gov processed this record on July 28, 2014