Postoperative Nausea and Vomiting and Acupuncture/Acupressure

NCT00965367 | Completed Phase 2

• 1 other identifier: 125/2007
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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:

1. 1.Treatment Group - standard treatment and acupuncture performed after induction of anaesthesia, acupressure administered before awakening
2. 2.Control Group - standard treatment

Conditions

Postoperative Vomiting; Nausea

Keywords

POV tonsillectomy adenoidectomy acupuncture acupressure child; Effectiveness of acupuncture on

Outcome Measures

Primary Outcomes (1)

• Postoperative nausea and vomiting

  24 hours

Secondary Outcomes (1)

• 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.

  24 hours

Study Arms (2)

Acustimulation

EXPERIMENTAL

Device: Acustimulation

Standard treatment group

NO INTERVENTION

Device: Acustimulation

Interventions

Acustimulation DEVICE

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.

Acustimulation; Standard treatment group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children scheduled for tonsillectomy and/or adenoidectomy
• Informed consent from the parents/guardians

You may not qualify if:

• 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

Sponsors & Collaborators

• National Research Centre of Complementary and Alternative Medicine, Norway: lead
• Lovisenberg Diaconale Hospital: collaborator

Study Sites (1)

Lovisenberg Diaconale Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Arne Johan Norheim, MD Doctor phD

  National Research Centre of Complementary and Alternative Medicine, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: May 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: August 25, 2009

Record last verified: 2009-08

Locations

NO (1)