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

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

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

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:

MedlinePlus related topics: Abdominal Pain Endoscopy Gallbladder Diseases Gallstones Pancreatitis

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

U.S. FDA Resources

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

No publications provided

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

Keywords provided by University of Rochester:

ERCP
EUS

Additional relevant MeSH terms:

Abdominal Pain
Gallstones
Cholelithiasis
Cholecystolithiasis
Gallbladder Diseases
Jaundice
Pancreatitis
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical
Hyperbilirubinemia

Pathologic Processes
Skin Manifestations
Pancreatic Diseases
Diphenhydramine
Promethazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists

ClinicalTrials.gov processed this record on February 09, 2012