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NCT00240123 Clinical Trial

Effect of Benadryl Sedation During ERCP or EUS

Abdominal Pain Clinical Trial

Official title:
Effect of Diphenhydramine Sedation During Endoscopic Retrograde Cholangio-pancreatography (ERCP) or Endoscopic Ultrasound (EUS)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00240123
Other study ID # 10454
Secondary ID
Status Withdrawn
Phase Phase 1
First received September 13, 2005
Last updated September 16, 2015
Start date July 2005
Est. completion date July 2007

Study information
Verified date September 2015
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.

Description:

The usual sedatives used for endoscopy are meperidine (Demerol) and midazolam (Versed). Benadryl (Diphenhydramine) is often used in addition to these medications in an effort to improve sedation. There is little published information regarding the use of diphenhydramine in conscious sedation. It is recognized that certain patients have features that predict difficult sedation such as prescription sedative use or heavy alcohol use. In addition, prolonged procedures like ERCP and EUS require higher doses of sedatives. Diphenhydramine may improve the quality of sedation in patients undergoing endoscopic retrograde cholangio-pancreatography (ERCP) or endoscopic ultrasound (EUS) procedures. You are being asked to participate because you are already scheduled to undergo one of these procedures.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients between 18 and 65 years of age who present for outpatient ERCP or EUS at Strong Memorial Hospital Endoscopy Center will be included

Exclusion Criteria:

- Allergy to diphenhydramine, narrow angle glaucoma, or inability to consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Benadryl versus Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Rochester

Outcome
Type Measure Description Time frame Safety issue
Primary Recovery score
Secondary Quality of sedation
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