Recruiting

Topical Lidocaine

Sponsor:

Brooke Army Medical Center

Code:

NCT02620501

Conditions

Dysphagia

GERD

Abdominal Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lidocaine

Placebo

Study Details

Brief summary:

Patients will be randomized to a placebo or study group who will receive topical lidocaine prior to EGD. Amount of medication used, recovery time, patient/endoscopist satisfaction will then be assessed.

Conditions

Dysphagia

GERD

Abdominal Pain

Study ID

NCT02620501

Start date

Jul, 2015

Status verified date

Dec, 2015

Completion date

May, 2016

Anticipated

Primary completion date

Feb, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • EGD alone performed by staff gastroenterologist as an outpatient
  • Between the age of 18 and 89
  • Not requiring anesthesia support or use of medications other than fentanyl and midazolam

Exclusion Criteria:

  • Prior history of head and neck surgery
  • Known hypersensitivity to local anesthetics, the amide type or any components of the topical lidocaine
  • Patients having interventions other than polypectomy performed
  • Pregnant or breast feeding females
  • Patients with severe liver impairment
  • Known hypersensitivity to benzodiazepine or fentanyl

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Patients will receive 10cc of 1/2 normal saline to gargle prior to EGD

experimental: Experimental

Patients will receive 10cc of 2% topical lidocaine to gargle prior to EGD

Interventions

Lidocaine

topical lidocaine

Placebo

0.45% Normal Saline

Primary outcome measure

  • Amount of sedation used [ Time Frame: 60 minutes ]

Central Contacts and Locations

Central contacts

Adam M Tritsch, MD

210-916-4367adam.m.tritsch.mil@mail.mil

Locations

Brooke Army Medical Center

Recruiting

Ft. Sam Houston, Texas, United States, 78219

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Dec 3, 2015

Last verified

Dec, 2015

Keywords

  • EGD
  • topical lidocaine
  • recovery time
  • intravenous sedation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2015-12-03.