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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.
 
ClinicalTrials.gov Identifier: NCT00240123
Recruitment Status : Withdrawn
First Posted : October 17, 2005
Last Update Posted : September 18, 2015
Sponsor:
Information provided by:
University of Rochester

Study Description
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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
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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
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Recovery score

Secondary Outcome Measures :
  1. Quality of sedation

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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 ClinicalTrials.gov identifier (NCT number): NCT00240123


Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Benedict Maliakkal, MD University of Rochester Medical Center, Digestive and Liver Disease Unit
More Information
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ClinicalTrials.gov Identifier: NCT00240123    
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:
ERCP
EUS
Additional relevant MeSH terms:
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Pancreatitis
Gallstones
Gallbladder Diseases
Abdominal Pain
Jaundice
Pancreatic Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Cholelithiasis
Biliary Tract Diseases
 Cholecystolithiasis
Calculi
Pathological Conditions, Anatomical
Diphenhydramine
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents