Phase 4
Completed N=120
Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids
Colonoscopy · Adjunct Anesthesia Medication
Source: ClinicalTrials.gov NCT01967433 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Dosage of Fentanyl — 125.4; 126.9 (μg)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dosage of Fentanyl |
125.4; 126.9 | — |
| SECONDARY Quality of Sedation |
6.2; 5.3; 5.6; 5.1 | — |
| SECONDARY Duration of Procedure |
34.8; 34.7; 34.4; 32.4; 6.4; 6.3 | — |
| SECONDARY Number of Participants With Adverse Events |
12; 22; 5; 3; 0; 0 | — |
| SECONDARY 24 Hour Follow up Pain Score |
2.0; 3.09 | — |
| SECONDARY Dosage of Midazolam |
4.9; 5.0 | — |
| SECONDARY 24 Hour Follow up Amnesia Score |
7.8; 6.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01967433). 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. Informational only — not medical advice.