Effect of Benadryl Sedation During ERCP or EUS - Full Text View

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 I

MedlinePlus related topics:

Abdominal Pain Endoscopy Gallbladder Diseases Gallstones

ChemIDplus related topics:

Diphenhydramine Diphenhydramine citrate Diphenhydramine hydrochloride Promethazine Promethazine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Effect of Diphenhydramine Sedation During Endoscopic Retrograde Cholangio-Pancreatography (ERCP) or Endoscopic Ultrasound (EUS)

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Recovery score

Secondary Outcome Measures:

Quality of sedation

Estimated Enrollment:	100
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
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

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

Study ID Numbers:	10454
First Received:	September 13, 2005
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00240123
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Rochester:

ERCP

EUS

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Cholecystolithiasis

Gallbladder Diseases

Cholelithiasis

Signs and Symptoms, Digestive

Gallstones

Abdominal Pain

Pain

Calculi

Histamine

Signs and Symptoms

Promethazine

Digestive System Diseases

Hyperbilirubinemia

Biliary Tract Diseases

Histamine phosphate

Pancreatic Diseases

Diphenhydramine

Pancreatitis

Jaundice

Additional relevant MeSH terms:

Skin Manifestations

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Gastrointestinal Agents

Anesthetics

Central Nervous System Depressants

Antiemetics

Histamine Agents

Anti-Allergic Agents

Anesthetics, Local

Pharmacologic Actions

Pathologic Processes

Histamine Antagonists

Sensory System Agents

Autonomic Agents

Therapeutic Uses

Hypnotics and Sedatives

Histamine H1 Antagonists

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00240123