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Effect of Benadryl Sedation During ERCP or EUS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00240123
Recruitment Status : Withdrawn
First Posted : October 17, 2005
Last Update Posted : September 18, 2015
Information provided by:
University of Rochester

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 Type : Interventional  (Clinical Trial)
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 : July 2005
Estimated Study Completion Date : July 2007

Primary Outcome Measures :
  1. Recovery score

Secondary Outcome Measures :
  1. Quality of sedation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00240123

Sponsors and Collaborators
University of Rochester
Principal Investigator: Benedict Maliakkal, MD University of Rochester Medical Center, Digestive and Liver Disease Unit Identifier: NCT00240123     History of Changes
Other Study ID Numbers: 10454
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: September 18, 2015
Last Verified: September 2015

Keywords provided by University of Rochester:

Additional relevant MeSH terms:
Abdominal Pain
Gallbladder Diseases
Pancreatic Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Pathologic Processes
Skin Manifestations
Biliary Tract Diseases
Pathological Conditions, Anatomical
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents