Effect of Benadryl Sedation During ERCP or EUS

Effect of Diphenhydramine Sedation During Endoscopic Retrograde Cholangio-pancreatography (ERCP) or Endoscopic Ultrasound (EUS)

The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.

Study Overview

• Status: Withdrawn
• Conditions: Abdominal Pain; Pancreatitis; Gallstones; Jaundice; Gallbladder Disease
• Intervention / Treatment: Drug: Benadryl versus Placebo

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 Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Recovery score

Secondary Outcome Measures

Outcome Measure
Quality of sedation

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Benedict Maliakkal, MD, University of Rochester Medical Center, Digestive and Liver Disease Unit

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Study Completion: July 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: October 13, 2005
• First Posted (Estimate): October 17, 2005

Study Record Updates

• Last Update Posted (Estimate): September 18, 2015
• Last Update Submitted That Met QC Criteria: September 16, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: ERCP; EUS
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pathological Conditions, Anatomical; Skin Manifestations; Biliary Tract Diseases; Pancreatic Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Hyperbilirubinemia; Abdominal Pain; Pancreatitis; Gallstones; Jaundice; Gallbladder Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Diphenhydramine
• Other Study ID Numbers: 10454 (UCSF-Mount Zion)