Recovery Agitation after Administration of Ketadex, Ketofol and Ketamine

Phase 3

• Conditions: recovery agitation.; Restlessness and agitation; R45.1

• Registration Number: IRCT20190422043340N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 May 2019

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 90

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

Patients showing serious adverse events of the drugs

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.