Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids

Completed · Phase 4 · Has a placebo group

Conditions studied: Colonoscopy, Adjunct Anesthesia Medication

In brief

To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to reduce the amount of standard sedatives used during colonoscopy in patients on chronic opioids.

Key facts

Study ID

NCT01967433

Run by

University of Oklahoma

People needed

120

Starts

2013-12-01

Expected to finish

2018-07-01

Last updated by the study team

2020-03-11

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18-64 years undergoing screening, surveillance, diagnostic and therapeutic colonoscopy
• Patient on chronic opioids defined as at least 5 mg of morphine or its equivalent at least 3 days per week for more than 3 months

You may not qualify if…

• Inability to execute informed consent
• Allergy to Diphenhydramine, fentanyl or midazolam
• Known or suspected pregnancy
• Endoscopic procedure without sedation
• Patient scheduled to have other endoscopic procedures on the same day
• Prior alimentary tract surgery
• Severe cardiopulmonary disease (ASA IV)
• Monoamine Oxidase Inhibitors (MOI) use within 2 weeks of procedure

Where it is running

• Veterans Affairs Medical Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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