Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids

NCT01967433 | Completed Phase 4 Results DMC

• 1 other identifier: DAASIPCO
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy; Adjunct Anesthesia Medication

Keywords

Fentanyl; Midazolam; Sedation; Patient tolerance; Duration of colonoscopy

Outcome Measures

Primary Outcomes (1)

• Dosage of Fentanyl

  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.

  From induction (first dose of sedative) to end of procedure

Secondary Outcomes (6)

• Quality of Sedation

  During the colonoscopy and 24 hours after discharge

• Duration of Procedure

  Time from induction (first dose of sedative) to discharge

• Number of Participants With Adverse Events

  From induction (first dose of sedative) to discharge

• 24 Hour Follow up Pain Score

  About 24 hours after the procedure

• Dosage of Midazolam

  From induction (first dose of sedative) to end of procedure

Study Arms (2)

Diphenhydramine

EXPERIMENTAL

Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives

Drug: Diphenhydramine

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives

Drug: Placebo

Interventions

Diphenhydramine DRUG

Also known as: Benadryl

Diphenhydramine

Placebo DRUG

Also known as: Normal Saline, 0.9% sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Veterans Affairs Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (11)

• Abraham NS, Fallone CA, Mayrand S, Huang J, Wieczorek P, Barkun AN. Sedation versus no sedation in the performance of diagnostic upper gastrointestinal endoscopy: a Canadian randomized controlled cost-outcome study. Am J Gastroenterol. 2004 Sep;99(9):1692-9. doi: 10.1111/j.1572-0241.2004.40157.x.

  PMID: 15330904 BACKGROUND

• Zubarik R, Ganguly E, Benway D, Ferrentino N, Moses P, Vecchio J. Procedure-related abdominal discomfort in patients undergoing colorectal cancer screening: a comparison of colonoscopy and flexible sigmoidoscopy. Am J Gastroenterol. 2002 Dec;97(12):3056-61. doi: 10.1111/j.1572-0241.2002.07101.x.

  PMID: 12492190 BACKGROUND

• Bergeron P, Enns J, Delima L, Dupuis JY, Wynands JE. Effects of routine premedication for cardiac catheterization on sedation, level of anxiety and arterial oxygen saturation. Can J Cardiol. 1995 Mar;11(3):201-5.

  PMID: 7889437 BACKGROUND

• Cook PJ, Flanagan R, James IM. Diazepam tolerance: effect of age, regular sedation, and alcohol. Br Med J (Clin Res Ed). 1984 Aug 11;289(6441):351-3. doi: 10.1136/bmj.289.6441.351.

  PMID: 6432093 BACKGROUND

• Pena LR, Mardini HE, Nickl NJ. Development of an instrument to assess and predict satisfaction and poor tolerance among patients undergoing endoscopic procedures. Dig Dis Sci. 2005 Oct;50(10):1860-71. doi: 10.1007/s10620-005-2952-7.

  PMID: 16187188 BACKGROUND

• Keeffe EB, O'Connor KW. 1989 A/S/G/E survey of endoscopic sedation and monitoring practices. Gastrointest Endosc. 1990 May-Jun;36(3 Suppl):S13-8.

  PMID: 2351253 BACKGROUND

• Hirsh I, Vaissler A, Chernin J, Segol O, Pizov R. Fentanyl or tramadol, with midazolam, for outpatient colonoscopy: analgesia, sedation, and safety. Dig Dis Sci. 2006 Nov;51(11):1946-51. doi: 10.1007/s10620-006-9413-9. Epub 2006 Sep 29.

  PMID: 17009113 BACKGROUND

• Tu RH, Grewall P, Leung JW, Suryaprasad AG, Sheykhzadeh PI, Doan C, Garcia JC, Zhang N, Prindiville T, Mann S, Trudeau W. Diphenhydramine as an adjunct to sedation for colonoscopy: a double-blind randomized, placebo-controlled study. Gastrointest Endosc. 2006 Jan;63(1):87-94. doi: 10.1016/j.gie.2005.08.015.

  PMID: 16377322 BACKGROUND

• Roach CL, Husain N, Zabinsky J, Welch E, Garg R. Moderate sedation for echocardiography of preschoolers. Pediatr Cardiol. 2010 May;31(4):469-73. doi: 10.1007/s00246-009-9622-z. Epub 2010 Jan 3.

  PMID: 20047024 BACKGROUND

• Hofmeister EH, Egger CM. Evaluation of diphenhydramine as a sedative for dogs. J Am Vet Med Assoc. 2005 Apr 1;226(7):1092-4. doi: 10.2460/javma.2005.226.1092.

  PMID: 15825733 BACKGROUND

• Husain Z, Hussain K, Nair R, Steinman R. Diphenhydramine induced QT prolongation and torsade de pointes: An uncommon effect of a common drug. Cardiol J. 2010;17(5):509-11.

  PMID: 20865683 BACKGROUND

MeSH Terms

Interventions

Diphenhydramine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Salman Nusrat
• Organization: University of Oklahoma Health Sciences Center and VAMC, Oklahoma City

salman-nusrat@ouhsc.edu

4052715428

Study Officials

• Salman Nusrat, MD

  University of Oklahoma

  STUDY DIRECTOR

• Mohammad Madhoun, MD MS

  Univeristy of Oklahoma Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 22, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 11, 2020
• Results First Posted: March 11, 2020

Record last verified: 2020-03

Locations

US (1)