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Effect of Benadryl Sedation During ERCP or EUS

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00240123
First received: September 13, 2005
Last updated: September 16, 2015
Last verified: September 2015
  Purpose
The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Effect of Diphenhydramine Sedation During Endoscopic Retrograde Cholangio-pancreatography (ERCP) or Endoscopic Ultrasound (EUS)

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Recovery score

Secondary Outcome Measures:
  • Quality of sedation

Enrollment: 0
Study Start Date: July 2005
Estimated Study Completion Date: July 2007
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240123

Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Benedict Maliakkal, MD University of Rochester Medical Center, Digestive and Liver Disease Unit
  More Information

ClinicalTrials.gov Identifier: NCT00240123     History of Changes
Other Study ID Numbers: 10454 
Study First Received: September 13, 2005
Last Updated: September 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
ERCP
EUS

Additional relevant MeSH terms:
Pancreatitis
Abdominal Pain
Jaundice
Gallstones
Gallbladder Diseases
Pancreatic Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Cholelithiasis
Biliary Tract Diseases
Cholecystolithiasis
Calculi
Pathological Conditions, Anatomical
Diphenhydramine
Promethazine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on September 28, 2016