Phase 4 N=120 Randomized Triple-blind Supportive Care

Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids

Colonoscopy · Adjunct Anesthesia Medication

Bottom Line

View on ClinicalTrials.gov: NCT01967433 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Dosage of Fentanyl — 125.4; 126.9 (μg)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Diphenhydramine (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Oklahoma
Primary completion: Mar 2018

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	—

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.

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

View full record on ClinicalTrials.gov →

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.