Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids
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|ClinicalTrials.gov Identifier: NCT01967433|
Recruitment Status : Unknown
Verified April 2017 by University of Oklahoma.
Recruitment status was: Active, not recruiting
First Posted : October 22, 2013
Last Update Posted : April 11, 2017
|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)|
|Estimated Enrollment :||150 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|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
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 and Midazolam [ Time Frame: Within 30 minutes of completion of colonoscopy ]
- 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. Patient will be asked to rate pain, sedation and amnesia on a 10 point scale 24 after discharge.
- Duration of Procedure [ Time Frame: Within 30 minutes of completion of colonoscopy ]Total time and time to reach cecum will be recorded.
- Adverse events [ Time Frame: During the colonoscopy and within 1 hour of completion of colonoscopy ]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 [ Time Frame: About 24 hours after the procedure ]Patient will be asked to rate the level of pain, amnesia and quality of sedation during the procedure using 10 point scale.
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|