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Recovery Agitation after Administration of Ketadex, Ketofol and Ketamine

The Comparison of Post-Operative Recovery Agitation after Three Analgesic Methods: Ketadex; Ketofol and Ketamine administration in the Emergency Departments in Iran

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190422043340N1
Enrollment
90
Registered
2019-05-14
Start date
2019-06-22
Completion date
Unknown
Last updated
2019-05-21

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

Conditions

"recovery agitation". Restlessness and agitation

Interventions

Intervention 1: Intervention group: Ketodex. Intervention 2: Intervention group: Ketofol. Intervention 3: Control group: Ketamine.

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 65 Years

Inclusion criteria

Inclusion criteria: Female/Male age over 3 years American Society of Anesthesiology physical status I to III (ASA I-III) VAS score of pain equal to or higher than 4 need for painful procedures in Emergency Department such as: Reduction of extremity fracture or dislocation and repair of skin lacerations

Exclusion criteria

Exclusion criteria: Patients showing serious adverse events of the drugs

Design outcomes

Primary

MeasureTime frame
Patient’s agitation and sedation consistency, assessed by RASS score (e.g. Richmond Agitation Sedation Scale). Timepoint: Patient’s agitation score and sedation consistency will be assessed by RASS score (Richmond Agitation Sedation Scale) within two minutes from induction of sedation and during recovery until 2 hours. Method of measurement: RASS score (Richmond Agitation Sedation Scale).

Secondary

MeasureTime frame
Heart Rate, oxygen saturation, systolic and diastolic blood pressure. Timepoint: Every five minutes from the start point of analgesia induction until 2 two hours after full recovery. Method of measurement: sphygmomonometer for blood pressure, pulse oxymeter for heart rate and blood oxygen saturation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSoheila Kouhestani

Esfahan University of Medical Sciences

dr_kouhestani@yahoo.com+98 31 3661 7840

Outcome results

None listed

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