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.
Reducing Ketamine-Induced Agitation, by Midazolam or Haloperidol Premedication After Adult Procedural Sedation
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.
Intervention / Treatment
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Midazolam (DRUG)Using Midazolam as a premedication for reducing ketamine-induced agitation
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Haloperidol (DRUG)Using Haloperidol as a premedication for reducing ketamine-induced agitation
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Placebo (DRUG)distilled water
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Ketamine (DRUG)Ketamine is routinely used for all procedural sedation in the patients.
Condition or Disease
- Ketamine Induced Agitation
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 185 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | Jul 01, 2016 | |
|---|---|---|
| Primary Completion: | Apr 01, 2017 | ACTUAL |
| Completion Date: | Jul 01, 2017 | ACTUAL |
| Study First Posted: | Sep 21, 2016 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Nov 04, 2017 |
Sponsors / Collaborators
Lead Sponsor:
Tehran University of Medical Sciences
Responsible Party:
N/A
Location
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).
Participant Groups
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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.
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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.
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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.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
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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.
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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.
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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 Outcomes
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assessed by a Clinician Satisfaction with Sedation Instrument(CSSI) questionnaire
More Details
| NCT Number: | NCT02909465 |
|---|---|
| Other IDs: | TehranUMS-ketamine |
| Study URL: | https://clinicaltrials.gov/study/NCT02909465 |
Last updated: Sep 29, 2023