Ketofol versus midazolam/fentanyl for Procedural Sedation and Analgesia in the Emergency Department: a Randomized, Prospective, Double-Blind Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201009204784N1

Enrollment

Registered

2010-11-28

Start date

2008-12-30

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

orthopedic procedures in the ED.

Interventions

Intervention 1: A single dose of Midazolam, 0.03mg/kg, IV as well as Phentanyl, 2 microgram/kg, IV, 3 minutes before the procedure. The next doses will be administered with half dose, if needed. Inter

Treatment - Drugs

A single dose of Midazolam, 0.03mg/kg, IV as well as Phentanyl, 2 microgram/kg, IV, 3 minutes before the procedure. The next doses will be administered with half dose, if needed

A single dose of Propofol, 1mg/kg, IV as well as Ketamine 1mg/kg, 2 microgram/kg, IV, 1.5 minutes before the procedure. The next doses will be administered with half dose, if needed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients requiring PSA for mainly orthopedic procedures in the ED Exclusion criteria: American Society of Anesthesia (ASA) physical status = 3; a history of adverse reaction to Ketamine, Propofol, Midazolam, Fentanyl or egg; pregnancy; increased intracranial pressure; multiple trauma and psychiatric diseases

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sedation. Timepoint: before and after procedure. Method of measurement: Ramsay Sedation Score.;Severity of Pain. Timepoint: before and after procedure. Method of measurement: VAS.	—

Secondary

Measure	Time frame
Blood pressure. Timepoint: before and after procedure. Method of measurement: checking blood pressure (non invasive).;Practitioner’s satisfaction. Timepoint: after the procedure. Method of measurement: Physician’s satisfaction ratings were recorded on a Visual Analog Scale (VAS), with 0= “very unsatisfied” and 10 = “completely satisfied”. Pain intensity was assessed by using a 10-cm VAS, with 0 = “no pain” and 10 = “worst possible pain.”.;Arterial oxygen saturation. Timepoint: before and after procedure. Method of measurement: pulse oximetry monitoring.;Heart rate. Timepoint: before and after procedure. Method of measurement: checking the pulse for one minute.;Side effects of prescribed drugs. Timepoint: before, during and after procedure. Method of measurement: observation.	—

Measure

Time frame

Blood pressure. Timepoint: before and after procedure. Method of measurement: checking blood pressure (non invasive).;Practitioner’s satisfaction. Timepoint: after the procedure. Method of measurement: Physician’s satisfaction ratings were recorded on a Visual Analog Scale (VAS), with 0= “very unsatisfied” and 10 = “completely satisfied”. Pain intensity was assessed by using a 10-cm VAS, with 0 = “no pain” and 10 = “worst possible pain.”.;Arterial oxygen saturation. Timepoint: before and after procedure. Method of measurement: pulse oximetry monitoring.;Heart rate. Timepoint: before and after procedure. Method of measurement: checking the pulse for one minute.;Side effects of prescribed drugs. Timepoint: before, during and after procedure. Method of measurement: observation.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Shariat Moharari

Tehran University of Medical Sciences

moharari@sina.tums.ac.ir+98 911 331 2758

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026