Procedural Sedation Using Propofol Versus Midazolam/Ketamine in the Adult Emergency Department

Procedural Sedation for Painful Orthopedic Manipulations With Propofol vs. Midazolam/Ketamine in the Adult Emergency Department

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00784498

Enrollment

Registered

2008-11-04

Start date

2008-11-30

Completion date

2009-09-30

Last updated

2010-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural Sedation

Keywords

Procedural sedation and analgesia, Emergency Department, propofol versus ketamine and midazolam, painful orthopedic manipulations

Brief summary

The use of procedural sedation and analgesia (PSA) to accomplish painful procedures in the emergency department (ED) has become a standard of practice over the last decade. Substantial variance exists regarding usage of medication for PSA, and many anesthetic agents have been proposed for this use. To our knowledge no head to head study compared the clinical effectiveness, safety profile and amnestic properties of midazolam/ketamine vs. propofol regimens for PSA in the adult ED setting. This prospective randomized trail can will help to evaluate the effectiveness and safety profile of Midazolam/katamine regimen for ED PSA in adults and will contribute to the discussion regarding propofol roll in the ED.

Interventions

DRUGKetamine/Midazolam

Intravenous bolus of midazolam 0.1mg/kg in titrated dose of 1 mg/min until spontaneous eye closure or up to 5mg (whichever comes first) followed by ketamine 0.5-1mg/kg (up to 100mg) in titrated dose of 10mg/30 seconds, to achieve the desired level of sedation

DRUGPropofol

Intravenous bolus of propofol 0.5-1mg/kg in titrated dose of 10mg/30seconds (up to 100mg) to achieve the desired level of sedation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients with orthopedic injuries requiring painful manipulation (i.e. reduction of fracture or dislocation, drainage of abscess, suture of extensive laceration) * Age between18-65 years * American Society of Anesthesiologists (ASA) score of 1 or 2 * Systolic blood pressure higher than 90 mmHg and lower than 160 mmHg before initiating sedation * Willingness and ability to provide an informed consent * No known hypersensitivity to either medication * No evidence of intoxication * No recent heavy meal.

Exclusion criteria

* Pregnant women and patients who do not meet the above criteria will be excluded.

Design outcomes

Primary

Measure	Time frame
The effectiveness and safety profile of procedural sedation using propofol versus midazolam/ketamine.	outcome measures will be monitored continuously and will be documented every few minutes from initiating sedation until the patient returns to his/her basic mental status

Secondary

Measure	Time frame
The amnestic properties of procedural sedation with propofol versus midazolam/ketamine.	Recall issues will be assessed after the patient returns to his/her basic mental status and within 72 hours from the procedure (either on a follow up visit or by a phone call)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026