Prevention of Emergence Agitation Using Ketofol as Adjunctive Therapy in Children Undergoing Strabismus Surgery: A Randomized Controlled Trial.
Phase 2
Recruiting
- Conditions
- Emergence agitation (EA) is common in pediatric patients after general anesthesia, particularly in high-risk operations like strabismus surgery. EA is characterized by disturbances in a child's awareness, leading to symptoms such as irritability, uncontrolled movements, and inconsolable crying. Excessive movement from EA will cause complications, including self-injury, dislodging intravenous catheters, dislodging surgical drains or tubes, surgical site damage, increasing costs of extra nursing care, and increased dissatisfaction among caregivers. EA causes very real distress to the child, parents, staff, and other postoperative children in the recovery ward.emergence agitation, ketofol, strabismus
- Registration Number
- TCTR20231102003
- Lead Sponsor
- Research Affairs, Faculty of Medicine, KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 94
Inclusion Criteria
Pediatric patient
Age from 2 to 5 years
Schedule for elective strabismus surgery under general anesthesia
American Society of Anesthesiologists (ASA) physical status class I, II
Parents give written informed consent
Exclusion Criteria
Patients with a history of allergy to propofol or ketamine
Unable to follow the study protocol
Developmental delay
Neurological or psychological disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Emergence agitation On arrival at PACU and then every 15 minutes until 60 minutes Emergence agitation score
- Secondary Outcome Measures
Name Time Method Pain score every 15 minutes until 60 minutes FLACC score,Nausea and vomiting at PACU The events of nausea and vomiting,Hypotension every 2 minutes after receiving the intervention until 10 minutes Blood pressure,Bradycardia every 2 minutes after receiving the intervention until 10 minutes Heart rate,Oxygen desaturation every 2 minutes after receiving the intervention until 10 minutes Oxygen saturation,Emergence times from time form discontinues anesthetic agent to awake time,PACU times from admit PACU until discharge from PACU time,Parent satisfaction before discharge from PACU numeric rating scale from 0 to 10