Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids
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|ClinicalTrials.gov Identifier: NCT01967433|
Recruitment Status : Completed
First Posted : October 22, 2013
Results First Posted : March 11, 2020
Last Update Posted : March 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy Adjunct Anesthesia Medication||Drug: Diphenhydramine Drug: Placebo||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|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|
Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives
Other Name: Benadryl
Placebo Comparator: Placebo
0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives
- 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.
- 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)
- 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.
- 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
- 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)
- 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.
- 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)
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
|United States, Oklahoma|
|Veterans Affairs Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Study Director:||Salman Nusrat, MD||University of Oklahoma|
|Principal Investigator:||Mohammad Madhoun, MD MS||Univeristy of Oklahoma Health Sciences Center|