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| Sponsored by: |
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: | 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) |
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | July 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | 10454 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00240123 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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ERCP EUS |
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Gallbladder Diseases Cholecystolithiasis Pathological Conditions, Anatomical Neurotransmitter Agents Signs and Symptoms, Digestive Abdominal Pain Anesthetics Antiemetics Pain Calculi Signs and Symptoms Promethazine Biliary Tract Diseases Hyperbilirubinemia Hypnotics and Sedatives |
Jaundice Cholelithiasis Gallstones Central Nervous System Depressants Anti-Allergic Agents Anesthetics, Local Histamine Digestive System Diseases Histamine Antagonists Pancreatic Diseases Histamine H1 Antagonists Histamine phosphate Peripheral Nervous System Agents Pancreatitis Diphenhydramine |
|
Cholecystolithiasis Gallbladder Diseases Pathological Conditions, Anatomical Skin Manifestations Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Abdominal Pain Physiological Effects of Drugs Anesthetics Antiemetics Pain Calculi Signs and Symptoms Pathologic Processes |
Sensory System Agents Therapeutic Uses Biliary Tract Diseases Hyperbilirubinemia Hypnotics and Sedatives Jaundice Cholelithiasis Gallstones Gastrointestinal Agents Central Nervous System Depressants Histamine Agents Anti-Allergic Agents Anesthetics, Local Pharmacologic Actions Digestive System Diseases |
