Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine

Emergence Delirium Clinical Trial

Official title:

Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04746079
• Other study ID #: 20-025
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: February 2023

Study information

• Verified date: May 2022
• Source: Mercy Health Ohio
• Contact: Todd Bolotin, MD
• Phone: (330) 219-3838
• Email: tbolotin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if positive imagery therapy while using ketamine in procedural sedation reduces the number of emergence reactions and impacts pre and post-procedural anxiety.

Description:

This is a multi-center, randomized controlled trial looking at if positive imagery therapy while using ketamine during procedural sedation will reduce the number of emergence reactions and impacts pre and post procedural anxiety. After informed consent has been established and the subject is determined to meet eligibility criteria, participants will be randomized into 2 groups. The interventional group will undergo positive imagery therapy during sedation and the control will not. The duration of subject participation will be from the onset of sedation beginning until the patient is recovered.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• at least 18 years of age

• requires procedural sedation in the emergency department for whom ketamine is selected by the provider as the medication for procedural sedation

Exclusion Criteria:

• age below 18 years of age

• any patient with a contraindication to the use of ketamine for the procedural sedation

• any prisoners

• pregnant females

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Procedural Sedation

Intervention

Behavioral:
• Positive Imagery Therapy
Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy.

Locations

Country	Name	City	State
United States	Mercy Health St Elizabeth Youngstown	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Mercy Health Ohio	Lake Erie College of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

References & Publications (19)

Akhlaghi N, Payandemehr P, Yaseri M, Akhlaghi AA, Abdolrazaghnejad A. Premedication With Midazolam or Haloperidol to Prevent Recovery Agitation in Adults Undergoing Procedural Sedation With Ketamine: A Randomized Double-Blind Clinical Trial. Ann Emerg Med. 2019 May;73(5):462-469. doi: 10.1016/j.annemergmed.2018.11.016. Epub 2019 Jan 3. — View Citation

Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12. — View Citation

Bergman SA. Ketamine: review of its pharmacology and its use in pediatric anesthesia. Anesth Prog. 1999 Winter;46(1):10-20. Review. — View Citation

Cheong SH, Lee KM, Lim SH, Cho KR, Kim MH, Ko MJ, Shim JC, Oh MK, Kim YH, Lee SE. Brief report: the effect of suggestion on unpleasant dreams induced by ketamine administration. Anesth Analg. 2011 May;112(5):1082-5. doi: 10.1213/ANE.0b013e31820eeb0e. Epub 2011 Feb 23. — View Citation

Green SM, Roback MG, Krauss B, Brown L, McGlone RG, Agrawal D, McKee M, Weiss M, Pitetti RD, Hostetler MA, Wathen JE, Treston G, Garcia Pena BM, Gerber AC, Losek JD; Emergency Department Ketamine Meta-Analysis Study Group. Predictors of emesis and recovery agitation with emergency department ketamine sedation: an individual-patient data meta-analysis of 8,282 children. Ann Emerg Med. 2009 Aug;54(2):171-80.e1-4. doi: 10.1016/j.annemergmed.2009.04.004. Epub 2009 Jun 6. — View Citation

Heilbrunn BR, Wittern RE, Lee JB, Pham PK, Hamilton AH, Nager AL. Reducing anxiety in the pediatric emergency department: a comparative trial. J Emerg Med. 2014 Dec;47(6):623-31. doi: 10.1016/j.jemermed.2014.06.052. Epub 2014 Sep 27. — View Citation

Huet A, Lucas-Polomeni MM, Robert JC, Sixou JL, Wodey E. Hypnosis and dental anesthesia in children: a prospective controlled study. Int J Clin Exp Hypn. 2011 Oct-Dec;59(4):424-40. doi: 10.1080/00207144.2011.594740. — View Citation

Newton A, Fitton L. Intravenous ketamine for adult procedural sedation in the emergency department: a prospective cohort study. Emerg Med J. 2008 Aug;25(8):498-501. doi: 10.1136/emj.2007.053421. — View Citation

Perumal DK, Adhimoolam M, Selvaraj N, Lazarus SP, Mohammed MA. Midazolam premedication for Ketamine-induced emergence phenomenon: A prospective observational study. J Res Pharm Pract. 2015 Apr-Jun;4(2):89-93. doi: 10.4103/2279-042X.155758. — View Citation

Roback MG, Wathen JE, Bajaj L, Bothner JP. Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs. Acad Emerg Med. 2005 Jun;12(6):508-13. — View Citation

Schwenk ES, Goldberg SF, Patel RD, Zhou J, Adams DR, Baratta JL, Viscusi ER, Epstein RH. Adverse Drug Effects and Preoperative Medication Factors Related to Perioperative Low-Dose Ketamine Infusions. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):482-7. doi: 10.1097/AAP.0000000000000416. — View Citation

Sener S, Eken C, Schultz CH, Serinken M, Ozsarac M. Ketamine with and without midazolam for emergency department sedation in adults: a randomized controlled trial. Ann Emerg Med. 2011 Feb;57(2):109-114.e2. doi: 10.1016/j.annemergmed.2010.09.010. — View Citation

Sherwin TS, Green SM, Khan A, Chapman DS, Dannenberg B. Does adjunctive midazolam reduce recovery agitation after ketamine sedation for pediatric procedures? A randomized, double-blind, placebo-controlled trial. Ann Emerg Med. 2000 Mar;35(3):229-38. — View Citation

Somashekara SC, Govindadas D, Devashankaraiah G, Mahato R, Deepalaxmi S, Srinivas V, Murugesh JV, Devanand. Midazolam premedication in attenuating ketamine psychic sequelae. J Basic Clin Pharm. 2010 Sep;1(4):209-13. Epub 2010 Nov 15. — View Citation

Stoker AD, Rosenfeld DM, Buras MR, Alvord JM, Gorlin AW. Evaluation of Clinical Factors Associated with Adverse Drug Events in Patients Receiving Sub-Anesthetic Ketamine Infusions. J Pain Res. 2019 Dec 23;12:3413-3421. doi: 10.2147/JPR.S217005. eCollection 2019. — View Citation

Strayer RJ, Nelson LS. Adverse events associated with ketamine for procedural sedation in adults. Am J Emerg Med. 2008 Nov;26(9):985-1028. doi: 10.1016/j.ajem.2007.12.005. Review. Erratum in: Am J Emerg Med. 2009 May;27(4):512. — View Citation

Treston G, Bell A, Cardwell R, Fincher G, Chand D, Cashion G. What is the nature of the emergence phenomenon when using intravenous or intramuscular ketamine for paediatric procedural sedation? Emerg Med Australas. 2009 Aug;21(4):315-22. doi: 10.1111/j.1742-6723.2009.01203.x. — View Citation

Trivedi S, Kumar R, Tripathi AK, Mehta RK. A Comparative Study of Dexmedetomidine and Midazolam in Reducing Delirium Caused by Ketamine. J Clin Diagn Res. 2016 Aug;10(8):UC01-4. doi: 10.7860/JCDR/2016/18397.8225. Epub 2016 Aug 1. — View Citation

Vardy JM, Dignon N, Mukherjee N, Sami DM, Balachandran G, Taylor S. Audit of the safety and effectiveness of ketamine for procedural sedation in the emergency department. Emerg Med J. 2008 Sep;25(9):579-82. doi: 10.1136/emj.2007.056200. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Richmond Agitation Sedation Score (RASS) for those receiving procedural sedation with and without ketamine	RASS score measured is -5 to +4. A lower score indicates someone is more alert, calm, drowsy indicating the patient has no emergence reaction. Higher score indicates an emergence reaction occurred.	From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.
Primary	Pittsburgh Agitation Score for those receiving procedural sedation with and without ketamine	PAS is measures from 0-16. A lower score indicated no agitation or emergence reaction while a higher score does.	From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.