Effect of Benadryl Sedation During ERCP or EUS

• Sponsor: University of Rochester (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00240123
• Collaborator: (none)
• Enrollment: 0
• Duration (Months): 24

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gallbladder Disease; Gallstones; Pancreatitis; Abdominal Pain; Jaundice	Drug: Benadryl versus Placebo	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Diagnostic
• Official Title: Effect of Diphenhydramine Sedation During Endoscopic Retrograde Cholangio-pancreatography (ERCP) or Endoscopic Ultrasound (EUS)
• Study Start Date: Jul 1, 2005
• Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. Recovery score []

Secondary Outcome Measures

1. Quality of sedation []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Rochester

Investigators

• Principal Investigator: Benedict Maliakkal, MD, University of Rochester Medical Center, Digestive and Liver Disease Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00240123
• Other Study ID Numbers: 10454
• First Posted: Oct 17, 2005
• Last Update Posted: Sep 18, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by , ,: ERCP; EUS
• Additional relevant MeSH terms: Pancreatitis; Gallstones; Gallbladder Diseases; Abdominal Pain; Jaundice; Diphenhydramine

Study Results

No Results Posted as of Sep 18, 2015