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Effect of Benadryl Sedation During ERCP or EUS

Information source: University of Rochester
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gallbladder Disease; Gallstones; Pancreatitis; Abdominal Pain; Jaundice

Intervention: Benadryl versus Placebo (Drug)

Phase: Phase 1

Status: Withdrawn

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Benedict Maliakkal, MD, Principal Investigator, Affiliation: University of Rochester Medical Center, Digestive and Liver Disease Unit


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

Clinical Details

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

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

Primary outcome: Recovery score

Secondary outcome: Quality of sedation

Detailed 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: July 2005
Last updated: July 8, 2008

Page last updated: August 23, 2015

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