Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Benadryl Sedation During ERCP or EUS

This study has been withdrawn prior to enrollment.
Information provided by:
University of Rochester Identifier:
First received: September 13, 2005
Last updated: July 8, 2008
Last verified: July 2008

September 13, 2005
July 8, 2008
July 2005
Not Provided
Recovery score
Same as current
Complete list of historical versions of study NCT00240123 on Archive Site
Quality of sedation
Same as current
Not Provided
Not Provided
Effect of Benadryl Sedation During ERCP or EUS
Effect of Diphenhydramine Sedation During Endoscopic Retrograde Cholangio-Pancreatography (ERCP) or Endoscopic Ultrasound (EUS)

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

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.

Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
  • Gallbladder Disease
  • Gallstones
  • Pancreatitis
  • Abdominal Pain
  • Jaundice
Drug: Benadryl versus Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2007
Not Provided

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
Not Provided
Not Provided
University of Rochester
Not Provided
Principal Investigator: Benedict Maliakkal, MD University of Rochester Medical Center, Digestive and Liver Disease Unit
University of Rochester
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP