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Prevention of Emergence Agitation Using Ketofol as Adjunctive Therapy in Children Undergoing Strabismus Surgery: A Randomized Controlled Trial.

Prevention of Emergence Agitation Using Ketofol as Adjunctive Therapy in Children Undergoing Strabismus Surgery: A Randomized Controlled Trial.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20231102003
Enrollment
94
Registered
2023-11-02
Start date
2023-12-07
Completion date
Unknown
Last updated
2026-08-03

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

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&#039

Interventions

Group ketofol will receive ketamine 0.25 mg/kg with propofol 1 mg/kg in total volume 10 ml.,Group saline will receive a normal saline total volume of 10 ml.
Active Comparator Drug,No Intervention No treatment
ketofol group,saline group

Sponsors

Research Affairs, Faculty of Medicine, KKU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 5 Years

Inclusion criteria

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

Exclusion criteria: Patients with a history of allergy to propofol or ketamine Unable to follow the study protocol Developmental delay Neurological or psychological disorders

Design outcomes

Primary

MeasureTime frame
Emergence agitation On arrival at PACU and then every 15 minutes until 60 minutes Emergence agitation score

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactPrathana Wittayapairoch

Srinagarind Hospital

prathana@kku.ac.th0896222682

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026