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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

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.

Condition or disease Intervention/treatment Phase
Ketamine Induced Agitation Drug: Midazolam Drug: Haloperidol Drug: placebo Drug: Ketamine Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Midazolam or Haloperidol Premedication Versus Placebo for Reducing Ketamine Induced Agitation After Adult Procedural Sedation in the Emergency Department
Study Start Date : July 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: placebo
distilled water

Drug: Ketamine
Ketamine is routinely used for all procedural sedation in the patients.
Other Name: ketalar

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.
Drug: Midazolam
Using Midazolam as a premedication for reducing ketamine-induced agitation
Other Name: verdes

Drug: placebo
distilled water

Drug: Ketamine
Ketamine is routinely used for all procedural sedation in the patients.
Other Name: ketalar

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.
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




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.



Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT02909465


Locations
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Iran, Islamic Republic of
Sina Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences

Publications:
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Responsible Party: Pooya Payandemehr, assistant professor of emergency medicine, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02909465     History of Changes
Other Study ID Numbers: TehranUMS-ketamine
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Ketamine
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Midazolam
Haloperidol
Haloperidol decanoate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators