Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy

VA Connecticut Healthcare System

Status: Completed

Conditions: Sedation; Endoscopy

Treatments: Drug: Midazolam; Drug: Diphenhydramine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01769586

0003

Details and patient eligibility

About

Patients who are undergoing colonoscopy and are not adequately sedated after initial standard sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive diphenhydramine vs. continued midazolam, and their level of sedation will be assessed. Our hypothesis is that diphenhydramine will provide better sedation than continued administration of midazolam during colonoscopy in patients not achieving adequate sedation with standard doses of midazolam plus fentanyl.

Full description

Patients who are undergoing colonoscopy and are not adequately sedated after initial standard sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive diphenhydramine (up to 3 incremental doses of 25 mcg each) vs. continued midazolam (up to 3 incremental doses of 1.5 mg each). the level of sedation will be assessed using the MOAA/S scale 2-3 minutes after each administration to determine if they are sufficiently sedated to begin colonoscopy. The patient, the healthcare team involved in performing the endoscopy, and the investigator assessing sedation will be blinded to the therapy. Our hypothesis is that diphenhydramine will provide better sedation than continued administration of midazolam during colonoscopy in patients not achieving adequate sedation with standard doses of midazolam plus fentanyl.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients >18 years-old who are undergoing elective colonoscopy with conscious sedation

Exclusion criteria

• allergy or prior adverse reactions to diphenhydramine
• medical contraindications to use of diphenhydramine (e.g. closed angle glaucoma)
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Diphenhydramine

Active Comparator group

Description:

Increments of 25 mcg to maximum of 3 times (total 75 mcg)

Treatment:

Drug: Diphenhydramine

Midazolam

Active Comparator group

Description:

1.5 mg increments up to 3 times (maximum 4.5 mg)

Treatment:

Drug: Midazolam