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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380182
• Other study ID #: 987983
• Status: Completed
• Phase: N/A
• Start date: April 5, 2017
• Est. completion date: February 6, 2019

Study information

• Verified date: April 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 6, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• PONV
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Other:
• Acupressure Band
These bands use pressure to stimulate the P6 acupuncture point.
• Sham Band
These sham bands are used to make it seem like the band is using pressure to stimulate the P6 acupuncture point.

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The evaluation of post operative nausea and vomiting at different time points during and after hospital stay.	number of emesis events	24 hours
Secondary	number of antiemetics administered during the study period,	number of antiemetics administered	24 hrs
Secondary	time to oral intake tolerance	time measured in minutes	24 hrs
Secondary	duration of recovery room stay	time measured in minutes	24 hours
Secondary	nausea requiring admission to hospital, emergency room or another medical care providers	Desc: number of events requiring ER visit, hospitalization or care from another medical care provider	24 hrs