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WithdrawnNCT00240123Updated Sep 18, 2015

Effect of Benadryl Sedation During ERCP or EUS

A Phase 1 interventional study of Benadryl versus Placebo in Gallbladder Disease, Gallstones and Pancreatitis, sponsored by University of Rochester. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-18.

Sponsored by University of Rochester · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Gallbladder Disease
  • Gallstones
  • Pancreatitis
  • Abdominal Pain
  • Jaundice

Keywords

  • ERCP
  • EUS
03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

Browse Pancreatitis studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Allergy to diphenhydramine, narrow angle glaucoma, or inability to consent
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
0 participants (actual)

Interventions

  • DrugBenadryl versus Placebo
06

What researchers measure

Primary outcomes

  1. Recovery score

Secondary outcomes

  1. Quality of sedation

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00240123
Lead sponsor
University of Rochester
First posted
Oct 17, 2005
Start date
Jul 2005
Completion
Jul 2007
Last update
Sep 18, 2015

Study contacts

Benedict Maliakkal, MD
principal investigator · University of Rochester Medical Center, Digestive and Liver Disease Unit
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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