Procedural SedationNCT04746079
Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine
A study testing Positive Imagery Therapy in people with Procedural Sedation and Emergence Delirium, run by Mercy Health Ohio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Procedural Sedation, Emergence Delirium
- What is being tested?
- Positive Imagery Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2021to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age below 18 years of age
- any patient with a contraindication to the use of ketamine for the procedural sedation
- any prisoners
- pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mercy Health St Elizabeth Youngstown
Youngstown, Ohio, 44504
Todd Bolotin, MD, 330-219-3838, tbolotin@gmail.com
Chad Donley, MD, 740-607-6318, chad.donley@alteonhealth.com
About this study
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.
Read the detailed 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.
- Conditions
- Procedural Sedation, Emergence Delirium
- Being tested
- Positive Imagery Therapy
- Keywords
- ketamine
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Imagery TherapyBehavioural
Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy.
| Study group | Role | What they receive |
|---|---|---|
| Positive Imagery Therapy | Experimental | Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy below:
"Relax and close your eyes. Take deep breaths in through your nose and out through your mouth as you listen to the sound of my voice. (Three second pause.) I want you to picture yourself lying on a towel on a soft sandy beach. (Three second pause.) You can see a palm trees swaying in the wind beneath a bright blue sky with a few white puffy clouds. (Three second pause.) You can feel the sand between your toes, the warm sunlight on your skin and a cool breeze. (Three second pause) You can smell coconut lotion in the breeze. (Three second pause.) You can hear the sound of waves gently crashing on the beach and seagulls crying in the distance. End of vignette Receives: Behavioral: Positive Imagery Therapy |
| Control | No intervention | Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds with no positive imagery therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.
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.
Measured: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start5 Feb 2021
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sealed envelope method.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy Health Ohio
- Sponsor type
- University, hospital or other
- Collaborators
- Lake Erie College of Osteopathic Medicine
- Responsible party
- Sponsor
- Investigators
- Todd Bolotin, MD, Principal investigator, Bon Secours Mercy Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746079
- Sponsor's protocol ID
- 20-025
- Status last verified
- May 2022
- First submitted
- 8 Feb 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20970888Akhlaghi 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.
PubMed 30611640Stoker 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.
PubMed 31920366Schwenk 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.
PubMed 27281730Sherwin 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. doi: 10.1016/s0196-0644(00)70073-4.
PubMed 10692189Vardy 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.
PubMed 18723707Newton 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.
PubMed 18660398Strayer 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.
PubMed 19091264Green 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.
PubMed 19501426Treston 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.
PubMed 19682018Somashekara 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.
PubMed 24825990Trivedi 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.
PubMed 27656531Perumal 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.
PubMed 25984547Bergman SA. Ketamine: review of its pharmacology and its use in pediatric anesthesia. Anesth Prog. 1999 Winter;46(1):10-20.
PubMed 10551055Roback 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. doi: 10.1197/j.aem.2004.12.009.
PubMed 15930401
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine
- ClinicalTrials.gov ID
- NCT04746079
- Acronym / sponsor ID
- 20-025
- Conditions
- Procedural Sedation, Emergence Delirium
- Keywords
- ketamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Mercy Health OhioUniversity, hospital or other
- Collaborators
- Lake Erie College of Osteopathic Medicine
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sealed envelope method.
| Arm | Type | Receives |
|---|---|---|
| Positive Imagery Therapy | Experimental | Behavioral: Positive Imagery TherapyPerform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy below: "Relax and close your eyes. Take deep breaths in through your nose and out through your mouth as you listen to the sound of my voice. (Three second pause.) I want you to picture yourself lying on a towel on a soft sandy beach. (Three second pause.) You can see a palm trees swaying in the wind beneath a bright blue sky with a few white puffy clouds. (Three second pause.) You can feel the sand between your toes, the warm sunlight on your skin and a cool breeze. (Three second pause) You can smell coconut lotion in the breeze. (Three second pause.) You can hear the sound of waves gently crashing on the beach and seagulls crying in the distance. End of vignette |
| Control | No intervention | –Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds with no positive imagery therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- age below 18 years of age
- any patient with a contraindication to the use of ketamine for the procedural sedation
- any prisoners
- pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Imagery TherapyPerform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy. | Behavioural | Positive Imagery Therapy |
Primary outcome
Richmond Agitation Sedation Score (RASS) for those receiving procedural sedation with and without ketamine
Time frame: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.
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.
Pittsburgh Agitation Score for those receiving procedural sedation with and without ketamine
Time frame: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.
PAS is measures from 0-16. A lower score indicated no agitation or emergence reaction while a higher score does.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Background: PubMed 20970888Sener 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.
- Background: PubMed 30611640Akhlaghi 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.
- Background: PubMed 31920366Stoker 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.
- Background: PubMed 27281730Schwenk 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.
- Background: PubMed 10692189Sherwin 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. doi: 10.1016/s0196-0644(00)70073-4.
- Background: PubMed 18723707Vardy 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.
- Background: PubMed 18660398Newton 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.
- Background: PubMed 19091264Strayer 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.
- Background: PubMed 19501426Green 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.
- Background: PubMed 19682018Treston 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.
- Background: PubMed 24825990Somashekara 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.
- Background: PubMed 27656531Trivedi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Bolotin, MD principal investigator
Bon Secours Mercy Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Imagery Therapy in people with Procedural Sedation and Emergence Delirium, run by Mercy Health Ohio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Todd Bolotin, MD ((330) 219-3838, tbolotin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richmond Agitation Sedation Score (RASS) for those receiving procedural sedation with and without ketamine (time frame: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04746079, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.