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

Primary Purpose

Ketamine Induced Agitation

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Midazolam
Haloperidol
placebo
Ketamine
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ketamine Induced Agitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sina Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

placebo

midazolam

haloperidol

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

agitation
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
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
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
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

clinician's satisfaction
assessed by a Clinician Satisfaction with Sedation Instrument(CSSI) questionnaire

Full Information

First Posted
July 28, 2016
Last Updated
November 4, 2017
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02909465
Brief Title
Reducing Ketamine-Induced Agitation, by Midazolam or Haloperidol Premedication After Adult Procedural Sedation
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketamine Induced Agitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
midazolam
Arm Type
Experimental
Arm Description
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.
Arm Title
haloperidol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
verdes
Intervention Description
Using Midazolam as a premedication for reducing ketamine-induced agitation
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Other Intervention Name(s)
haldol
Intervention Description
Using Haloperidol as a premedication for reducing ketamine-induced agitation
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
distilled water
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
ketalar
Intervention Description
Ketamine is routinely used for all procedural sedation in the patients.
Primary Outcome Measure Information:
Title
agitation
Description
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.
Time Frame
starts at the time of Ketamine injection through recovery period(maximum of 2 hours)
Title
level of sedation
Description
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.
Time Frame
5 minutes after Ketamine injection
Title
level of sedation
Description
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.
Time Frame
15 minutes after Ketamine injection
Title
level of sedation
Description
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.
Time Frame
30 minutes after Ketamine injection
Secondary Outcome Measure Information:
Title
clinician's satisfaction
Description
assessed by a Clinician Satisfaction with Sedation Instrument(CSSI) questionnaire
Time Frame
starts at the time of Ketamine injection through recovery period(maximum of 2 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Sina Hospital
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20970888
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.
Results Reference
background
PubMed Identifier
18660398
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.
Results Reference
background
PubMed Identifier
23862031
Citation
Amr MA, Shams T, Al-Wadani H. Does haloperidol prophylaxis reduce ketamine-induced emergence delirium in children? Sultan Qaboos Univ Med J. 2013 May;13(2):256-62. doi: 10.12816/0003231. Epub 2013 May 9.
Results Reference
background
PubMed Identifier
10730829
Citation
Chudnofsky CR, Weber JE, Stoyanoff PJ, Colone PD, Wilkerson MD, Hallinen DL, Jaggi FM, Boczar ME, Perry MA. A combination of midazolam and ketamine for procedural sedation and analgesia in adult emergency department patients. Acad Emerg Med. 2000 Mar;7(3):228-35. doi: 10.1111/j.1553-2712.2000.tb01064.x.
Results Reference
background
PubMed Identifier
30611640
Citation
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.
Results Reference
derived

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

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