Ketodex Efficacy for adult procedural sedation

Ketamine-Dexmedetomidine (Ketodex) versus Ketamine and ketofol for adult procedural sedation in Emergency Department

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130108012072N13

Enrollment

135

Registered

2022-08-30

Start date

2022-09-23

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Adult procedural sedation.

Interventions

Intervention 1: Intervention group 1: 1 mg/kg diluted Ketamine in 20 ml normal saline. Intervention 2: Intervention group 2: 0.5 mg/kg diluted Ketofol in 20 ml normal saline. Intervention 3: Intervent

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with pain severity status of Anesthesiology physical status I to III (ASA I-III), Visual Analog Scale>4

Exclusion criteria

Exclusion criteria: ?Addiction to drugs and analgesics Use of analgesics in 24 hours ego Underlying disease such as hypertension, liver and kidney disease) Pregnancy Psychiatric disease such as psychosis Severe verbal or hearing disability Sensitivity to Ketamine, Ketofol and Ketodex

Design outcomes

Primary

Measure	Time frame
Pain severity score with Visual Analog Scale. Timepoint: Study beginning, 30 minutes and 1 hour and 2 hours after treatment. Method of measurement: Visual Analog Scale.;Sedation level with Ramsay Sedation Score (RASS). Timepoint: Study beginning, 30 minutes and 1 hour and 2 hours after treatment. Method of measurement: Ramsay Sedation Score (RASS).	—

Secondary

Measure	Time frame
Hemodynamic changes. Timepoint: Study beginning, 30 minutes and 1 hour and 2 hours after treatment. Method of measurement: Manometer; Heart rate; Pulseoximetry.;Agitation. Timepoint: Study beginning, 30 minutes and 1 hour and 2 hours after treatment. Method of measurement: Checklist.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Esmailian

Esfahan University of Medical Sciences

m_esmailian@med.mui.ac.ir+98 31 3629 3482

Outcome results

None listed

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