Effect of Benadryl Sedation During ERCP or EUS
Information source: University of Rochester
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gallbladder Disease; Gallstones; Pancreatitis; Abdominal Pain; Jaundice
Intervention: Benadryl versus Placebo (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: University of Rochester Official(s) and/or principal investigator(s):
Benedict Maliakkal, MD, Principal Investigator, Affiliation: University of Rochester Medical Center, Digestive and Liver Disease Unit
Summary
The purpose of the study is to determine if adding Benadryl improves sedation for patients
scheduled to undergo ERCP or EUS procedures.
Clinical Details
Official title: Effect of Diphenhydramine Sedation During Endoscopic Retrograde Cholangio-Pancreatography (ERCP) or Endoscopic Ultrasound (EUS)
Study design: Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Recovery score
Secondary outcome: Quality of sedation
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Rochester Medical Center, Rochester, New York 14642, United States
Additional Information
Starting date: July 2005
Last updated: April 17, 2007
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