Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01967433
Recruitment Status : Completed
First Posted : October 22, 2013
Results First Posted : March 11, 2020
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Brief 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.

Condition or disease Intervention/treatment Phase
Colonoscopy Adjunct Anesthesia Medication Drug: Diphenhydramine Drug: Placebo Phase 4

Detailed Description:

Specific Aims:

The primary aim of our study is to determine if addition of Diphenhydramine to Fentanyl and Midazolam will decrease the dose of Fentanyl and Midazolam used during colonoscopy in individuals on chronic opioids. Secondarily we will be looking at quality of sedation, duration of colonoscopy, time to reach cecum and adverse effects (hypoxia defined as O2 saturation less than 89% lasting for more than 30 seconds, hypotension defined as systolic BP less than 90 mmhg and use of reversal agents i.e Naloxone or Flumazenil).

Day of Procedure:

After consent is obtained the medical records of the patients will be reviewed and demographic information, co-morbidities, current medication will be extracted and recorded.

On the day of colonoscopy Alcohol use disorder inventory (AUDIT) will be used to screen for alcohol abuse. AUDIT was developed by World Health Organization and has been validated over a period of 2 decades. It consist of 10 questions, each question is scored 0-4 on the basis of subjects alcohol use. It takes about 2-4 minutes to complete. A score 10 or greater is highly specific or alcohol use.

Subjects will be checked in and prepared according to routine protocols of the VA medical center. Participants will be randomly assigned to receive either 50 mg of diphenhydramine or 10 ml of 0.9% sodium chloride. On the day of colonoscopy randomization will be performed by an independent investigator who is a pharmacist at VA medical center using the website http://www.randomization.com. She will also prepare and dispense medication. Each endoscopy team will consist of an attending gastroenterologist, gastroenterology fellow and two nurses. Medications will be administered by one of the nurses under the direct supervision of the physician.

At the start of procedure baseline vitals will be recorded as per our unit's policy. Research medication will be administered 3 minutes prior to administration of other medications. Neither the patient nor the medical staff including the endoscopist will be aware of the contents of the vial. Conscious sedation will be achieved using a combination of intravenous midazolam and fentanyl as standard sedative. Rarely, additional diphenhydramine will be given, on the basis of the judgment of the endoscopist. During the procedure vital signs including oxygen saturation will be monitored at 3-5 minute interval. Procedure related complications, including hypotension, desaturation and cardiac arrhythmia will be managed according to our endoscopy unit policy and protocols.

Following the procedure, the nurse and the fellow or the attending will individually rate the quality if sedation on a ten-point Likert scale. Qualitative assessment will also be made (Under-sedated, adequately sedated, or over-sedated).

Recovery time will be recorded.

Day Following the Colonoscopy Twenty-four hour discharge a follow up call will be made and the patients will be asked to evaluate the level of sedation on a 10-point scale (1, inadequate; 10 completely without discomfort); pain (1, no pain; 10 severe pain), and amnesia (10, no memory of the procedure; 1 complete memory).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Use of Diphenhydramine as an Adjunctive Sedative for Colonoscopy in Patients Chronically on Opioids
Study Start Date : December 2013
Actual Primary Completion Date : March 2018
Actual Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Diphenhydramine
Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives
Drug: Diphenhydramine
Other Name: Benadryl

Placebo Comparator: Placebo
0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives
Drug: Placebo
Other Names:
  • Normal Saline
  • 0.9% sodium chloride




Primary Outcome Measures :
  1. Dosage of Fentanyl [ Time Frame: From induction (first dose of sedative) to end of procedure ]
    Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.


Secondary Outcome Measures :
  1. Quality of Sedation [ Time Frame: During the colonoscopy and 24 hours after discharge ]

    Quality of sedation will be accessed by the nurse and the physician at the end of procedure.

    Name: 10 point visual analogue scale Minimum score: 1 (worse) Maximum score: 10 (better)


  2. Duration of Procedure [ Time Frame: Time from induction (first dose of sedative) to discharge ]
    Induction period (time from first dose of fentanyl to scope insertion), procedural time (time from scope insertion to scope out), and recovery time (time from scope out to discharge) were recorded by the nursing staff in their standard documentation.

  3. Number of Participants With Adverse Events [ Time Frame: From induction (first dose of sedative) to discharge ]
    Following adverse events will be recorded: (1)Hypoxia defined as O2 saturation less than 89% lasting for more than 30 seconds, (2)hypotension defined as systolic BP less than 90 mmhg and (3)use of reversal agents i.e Naloxone or Flumazenil

  4. 24 Hour Follow up Pain Score [ Time Frame: About 24 hours after the procedure ]

    At 24 hr follow up patients were asked to rate the level of pain during the procedure using 10 point scale.

    10 point visual analogue scale minimum= 0 (better) maximum =10 (worse)


  5. Dosage of Midazolam [ Time Frame: From induction (first dose of sedative) to end of procedure ]
    Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.

  6. 24 Hour Follow up Amnesia Score [ Time Frame: At about 24 after the procedure ]
    Patient were also asked to rate amnesia on a 10 point scale 24 after discharge. minimum= 0 (worse) maximum =10 (better)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967433


Locations
Layout table for location information
United States, Oklahoma
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Layout table for investigator information
Study Director: Salman Nusrat, MD University of Oklahoma
Principal Investigator: Mohammad Madhoun, MD MS Univeristy of Oklahoma Health Sciences Center
  Study Documents (Full-Text)

Documents provided by University of Oklahoma:
Publications:

Layout table for additonal information
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01967433    
Other Study ID Numbers: DAASIPCO
First Posted: October 22, 2013    Key Record Dates
Results First Posted: March 11, 2020
Last Update Posted: March 11, 2020
Last Verified: March 2020
Keywords provided by University of Oklahoma:
Fentanyl
Midazolam
Sedation
Patient tolerance
Duration of colonoscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Diphenhydramine
Promethazine
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Antipruritics
Dermatologic Agents