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This study has been withdrawn prior to enrollment.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

History of Changes

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 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:

Genetics Home Reference related topics: hereditary pancreatitis

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Diphenhydramine hydrochloride Diphenhydramine citrate

U.S. FDA Resources

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)
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

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

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 June 23, 2017

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