N/A
N=200
Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy
Sedation · Endoscopy
Bottom Line
View on ClinicalTrials.gov: NCT01769586 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3) — 27; 65 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diphenhydramine (Drug); Midazolam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Connecticut Healthcare System
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3) |
27; 65 | <0.001 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01769586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.