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Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery

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ClinicalTrials.gov Identifier: NCT03380182
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
The specific aim of this study is to determine the incidence of post-operative nausea and vomiting (PONV) in the pediatric population undergoing outpatient middle ear surgery.

Condition or disease Intervention/treatment Phase
Nausea Vomiting PONV Other: Acupressure Band Other: Sham Band Not Applicable

Detailed Description:
The specific aim of this study is to determine the incidence of post-operative nausea and vomiting (PONV) in the pediatric population undergoing outpatient middle ear surgery receiving our institution's standard dual prophylactic antiemetic therapy in combination with intraoperative acupuncture and postoperative acupressure compared to those receiving only the standard dual prophylactic antiemetic therapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : March 14, 2019
Estimated Study Completion Date : March 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture/Acupressure Group
Bilateral P6 point acupuncture will be performed intra-operatively by the PI, who has UC Davis Medical Center privilege for this specific acupuncture, while the patient is under anesthesia. Patient will be sent home with an acupressure band, which is to remain on for 24 hours post operatively.
Other: Acupressure Band
These bands use pressure to stimulate the P6 acupuncture point.

Sham Comparator: Control Group
Bilateral sham point acupuncture will be performed intra-operatively. Patient will be sent home with a wrist sham band matching in appearance of acupressure bands without the acupressure function, which is to remain on for 24 hours post operatively.
Other: Sham Band
These sham bands are used to make it seem like the band is using pressure to stimulate the P6 acupuncture point.




Primary Outcome Measures :
  1. The evaluation of post operative nausea and vomiting at different time points during and after hospital stay. [ Time Frame: 24 hours ]
    number of emesis events


Secondary Outcome Measures :
  1. number of antiemetics administered during the study period, [ Time Frame: 24 hrs ]
    number of antiemetics administered

  2. time to oral intake tolerance [ Time Frame: 24 hrs ]
    time measured in minutes

  3. duration of recovery room stay [ Time Frame: 24 hours ]
    time measured in minutes

  4. nausea requiring admission to hospital, emergency room or another medical care providers [ Time Frame: 24 hrs ]
    Desc: number of events requiring ER visit, hospitalization or care from another medical care provider



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy ASA 1 and 2 Patients
  • Age 2 to 18 years old
  • Undergoing Outpatient Middle ear surgery

Exclusion Criteria:

  • ASA 3 and above
  • Patients with underlying pro-emetogenic disease
  • Patients currently taking antiemetic agents
  • pregnant women
  • Cognitively impaired adults
  • prisoners
  • History of bleeding disorder
  • Age less than 2 or greater than 18

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 ClinicalTrials.gov identifier (NCT number): NCT03380182


Contacts
Contact: Sungeun Lee 916-734-5028 geulee@ucdavis.edu
Contact: Ana Arias, 91 916-703-5456 apaarias@ucdavis.edu

Locations
United States, California
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Sungeun Lee    916-734-5028    geulee@ucdavis.edu   
Contact: Ana Arias    916-703-5456    apaarias@ucdavis.edu   
Principal Investigator: Sungeun Lee, MD         
Sponsors and Collaborators
University of California, Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03380182     History of Changes
Other Study ID Numbers: 987983
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:
acupuncture
acupressure

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