Skip to content

Propofol-ketamine versus midazolam-ketamine for pediatric sedation during endoscopic exam

Comparison of midazolam-ketamine and propofol-ketamine as sedatives for gastrointestinal endoscopic exam in children: a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0006216
Enrollment
126
Registered
2021-06-02
Start date
2021-10-12
Completion date
Unknown
Last updated
2022-03-08

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

Conditions

None listed

Interventions

Drug : As sedative for gastrointestinal endoscopy in children, midazolam and ketamine are used for children in one group, while propofol and ketamine are used for children in the other group.

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children aged between 3 and 17 years old who are planned to undergo gastrointestinal endoscopy under monitored anesthesia care

Exclusion criteria

Exclusion criteria: ? Presence of upper respiratory tract infection or pulmonary disease ? Underlying airway compromise such as laryngomalacia, tracheomalacia or subglottic stenosis ? History of hypersensitivity to midazolam, ketamine or propofol ? Presence of allergy to beans or peanuts ? History of seizure attack ? Presence of arrhythmia, tachycardia, or bradycardia ? Decline to enroll from one of the patient's parents or legal guardians ? Other conditions that are regarded as inappropriate for the study

Design outcomes

Primary

MeasureTime frame
Length of stay at the postanesthesia care unit;Rate of appearance of any adverse events at the postanesthesia care unit

Secondary

MeasureTime frame
Pediatric sedation state scale during the procedure;Modified Aldrete score on arrival at the postanesthesia care unit;Satisfaction of the patient's guardian after discharge from the postanesthesia care unit;Occurrence of adverse events during sedation;Occurrence rate of adverse events during sedation;Proportion of the patients who required rescue ventilation during sedation;Kind of rescue ventilation;Maximal decrement of the mean blood pressure

Countries

Korea, Republic of

Contacts

Public ContactSang-Hwan Ji

Seoul National University Hospital

taepoongshin@gmail.com+82-2-2072-3661

Outcome results

None listed

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