Effect of Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol on Recovery Profile in Pediatrics Undergoing Adenotonsillectomy.

Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol. Effect on Emergence Agitation and Recovery Profile After Pediatric Adenotonsillectomy: A Randomized Comparative Study.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06010927

Enrollment

140

Registered

2023-08-25

Start date

2023-08-25

Completion date

2023-12-31

Last updated

2023-09-15

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

Conditions

Emergence Delirium

Brief summary

An optimum recovery profile after AT includes a rapid, smooth awakening without emergence agitation (EA), stable vital signs and oxygenation, reduced postoperative nausea and vomiting (PONV), controlled postoperative pain, and patient or parents' satisfaction. Ketamine is a low-cost drug with a wide therapeutic window. Ketamine is a competitive N-methyl-D-aspartate receptor antagonist with good analgesic properties and periprocedural amnesia. The ketamine/midazolam combination was administered in different ways with controversial results about their effect on the EA and recovery profile. Ketofol, a mixture of ketamine and propofol, has been used in different favorable recovery profiles regarding postoperative EA and PONV. This study aims to evaluate the effect of premedication with an intramuscular ketamine/ midazolam combination versus pre-extubation ketofol on the EA and the recovery profile.

Interventions

DRUGketamine/midazolam

premedication

DRUGKetofol

Pre-extubation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 10 Years

Healthy volunteers

Inclusion criteria

* ASA physical status I or II * Children scheduled for AT under general anesthesia (GA).

Exclusion criteria

* Congenital cardiovascular anomalies * Behavioral changes * Delayed physical development * Children receiving sedatives or anticonvulsants therapy

Design outcomes

Primary

Measure	Time frame
incidence of Emergence agitation	starting from time of PACU admission after recover from anesthesia till 6 hours postoperative

Countries

Egypt

Contacts

Primary ContactAbeer Ahmed

abeer_ahmed@kasralainy.edu.eg01005244590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026