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Reducing Ketamine-Induced Agitation, by Midazolam or Haloperidol Premedication After Adult Procedural Sedation

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ClinicalTrials.gov Identifier: NCT02909465
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Pooya Payandemehr, Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE September 21, 2016
Last Update Posted Date November 7, 2017
Study Start Date  ICMJE July 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
  • agitation [ Time Frame: starts at the time of Ketamine injection through recovery period(maximum of 2 hours) ]
    assessed by Pittsburgh Agitation Scale(scoring 0 to 16). Pittsburgh Agitation Scale(scoring 0 to 16) is a valid and reliable instrument to assess agitation severity of inpatients.
  • level of sedation [ Time Frame: 5 minutes after Ketamine injection ]
    assessed by Richmond Agitation-Sedation Scale(scoring -5 to +4). Richmond Agitation-Sedation Scale(scoring -5 to +4) is a valid and reliable instrument to assess level of sedation and agitated behavior during sedation.
  • level of sedation [ Time Frame: 15 minutes after Ketamine injection ]
    assessed by Richmond Agitation-Sedation Scale(scoring -5 to +4). Richmond Agitation-Sedation Scale(scoring -5 to +4) is a valid and reliable instrument to assess level of sedation and agitated behavior during sedation.
  • level of sedation [ Time Frame: 30 minutes after Ketamine injection ]
    assessed by Richmond Agitation-Sedation Scale(scoring -5 to +4). Richmond Agitation-Sedation Scale(scoring -5 to +4) is a valid and reliable instrument to assess level of sedation and agitated behavior during sedation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
clinician's satisfaction [ Time Frame: starts at the time of Ketamine injection through recovery period(maximum of 2 hours) ]
assessed by a Clinician Satisfaction with Sedation Instrument(CSSI) questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Ketamine-Induced Agitation, by Midazolam or Haloperidol Premedication After Adult Procedural Sedation
Official Title  ICMJE A Comparison of Midazolam or Haloperidol Premedication Versus Placebo for Reducing Ketamine Induced Agitation After Adult Procedural Sedation in the Emergency Department
Brief Summary Ketamine is the cornerstone of procedural sedation in emergency department but ketamine induced agitation has limited its usage by many physicians. As a solution, some propose using midazolam or haloperidol before ketamine injection. In this randomized double blind clinical trial, patients who are eligible for sedation by ketamine are allocated in 3 groups. In first group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg of haloperidol and in 3rd group a placebo five minutes before receiving the sedative dose of ketamine (1 mg/kg). The patients are assessed for agitation during and after the procedure the clinician's satisfaction with sedation instrument is evaluated after the procedure.
Detailed Description Ketamine is the cornerstone of procedural sedation in emergency department but ketamine induced agitation has limited its usage by many physicians. As a solution, some propose using midazolam or haloperidol before ketamine injection. In this randomized double blind clinical trial, patients who are eligible for sedation by ketamine are allocated in 3 groups. In first group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg of haloperidol and in 3rd group a placebo five minutes before receiving the sedative dose of ketamine (1 mg/kg). The patients are assessed for agitation during and after the procedure the clinician's satisfaction with sedation instrument is evaluated after the procedure. The investigator will fill standard questionnaires for agitation assessment (Richmond Agitation-Sedation Scale and Pittsburgh Agitation Scale).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ketamine Induced Agitation
Intervention  ICMJE
  • Drug: Midazolam
    Using Midazolam as a premedication for reducing ketamine-induced agitation
    Other Name: verdes
  • Drug: Haloperidol
    Using Haloperidol as a premedication for reducing ketamine-induced agitation
    Other Name: haldol
  • Drug: placebo
    distilled water
  • Drug: Ketamine
    Ketamine is routinely used for all procedural sedation in the patients.
    Other Name: ketalar
Study Arms  ICMJE
  • Placebo Comparator: placebo
    To do procedural sedation and analgesia in this group, the patients will receive 2 intravenous injections of distilled water (one 2 ml and the other 0.05 cc/kg) 5 minutes before receiving a sedative dose of 1 mg/kg IV ketamine.
    Interventions:
    • Drug: placebo
    • Drug: Ketamine
  • Experimental: midazolam
    To do procedural sedation and analgesia in this group, the patients will receive 2 intravenous injections. one will be 2 ml of distilled water and the other 0.05 mg/kg midazolam, 5 minutes before receiving a sedative dose of 1 mg/kg IV ketamine.
    Interventions:
    • Drug: Midazolam
    • Drug: placebo
    • Drug: Ketamine
  • Experimental: haloperidol
    To do procedural sedation and analgesia in this group, the patients will receive 2 intravenous injections. One will be 0.05 cc/kg of distilled water and the other 5 mg of haloperidol (in 2 cc syringes), 5 minutes before receiving a sedative dose of 1 mg/kg IV ketamine.
    Interventions:
    • Drug: Haloperidol
    • Drug: placebo
    • Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2017)
185
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2016)
180
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patient older than 18, who need to sedate in Emergency Department

Exclusion Criteria:

  • age younger than 18 years,
  • patients with significant cardiovascular disease,congestive heart failure (CHF)
  • central nervous system lesions or injuries, increased intracranial pressure (ICP)
  • ocular pathology, increased intraocular pressure (IOP)
  • thyroid disease,
  • acute pulmonary infections,
  • conditions requiring stimulation of the posterior pharynx,
  • had ingested solid food in the previous 4 hours or clear liquids in the previous 2 hours.
  • Acute intermittent porphyria
  • Alcoholism
  • Hepatic Impairment
  • Myasthenia gravis
  • Respiratory depression
  • allergy to haloperidol as established by direct questioning of family members and available medical history,
  • moderate to severe dementia as documented by medical history,
  • Parkinson's disease,
  • corrected QTc interval (QTc) greater than 500 ms,
  • usage of drugs prolonging QT-interval,
  • history of torsades de pointes,
  • history of neuroleptic malignant syndrome,
  • family history of dystonic reactions to drugs,
  • epilepsy or history of seizures
  • chronic psychiatric disease,
  • intoxication
  • bone marrow suppression
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02909465
Other Study ID Numbers  ICMJE TehranUMS-ketamine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Pooya Payandemehr, Tehran University of Medical Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tehran University of Medical Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tehran University of Medical Sciences
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP