Trials Sponsors Conditions Drugs Pricing

Conditions

Emergence Delirium in Pediatric Anesthesia

Keywords

DexmedetomidineBurn Procedural sedation

Outcome Measures

Primary Outcomes (1)

Incidence of emergence delirium
Incidence of emergence delirium within 30 minutes after the end of anesthesia, defined as a Pediatric Anesthesia Emergence Delirium (PAED) Scale score ≥ 10 at any assessment point. The Pediatric Anesthesia Emergence Delirium (PAED) Scale is a validated instrument ranging from 0 to 20, where higher scores indicate more severe emergence delirium (worse outcome).
within 30 minutes after end of anesthesia

Secondary Outcomes (3)

Total Opiod requirments
Perioperative period
Hemodynamic stability
Baseline (pre-sedation), intraoperative period (every 5 minutes), and up to 30 minutes postoperatively
The duration of stay in PACU
Within 30 minutes after the end of anesthesia, with assessment performed during recovery ( every 5 minutes)

Study Arms (2)

Midazolam - Ketamine Group

EXPERIMENTAL

Drug

Drug: Midazolam + Ketamine

Dexmedetomidine

EXPERIMENTAL

Drug

Drug: Dexmedetomidine (DEX)

Interventions

Midazolam + KetamineDrug

Participants will receive intravenous midazolam (0.05 mg/kg) combined with ketamine (1 mg/kg). Supplemental ketamine doses (0.5 mg/kg) will be administered as needed to maintain adequate deep sedation during burn-related procedures.

Midazolam - Ketamine Group

Dexmedetomidine (DEX)Drug

Participants will receive intravenous dexmedetomidine (loading dose 1 mcg/kg over 15 minutes, followed by infusion 0.5-1 mcg/kg/hour) adjusted to maintain adequate deep sedation during burn-related procedures.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Midazolam + Ketamine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age3 Years - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Age from 3 to 16 years
Both sexes

Sponsors & Collaborators

Ain Shams University
Otherlead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

Hebatalla M Ahmed, Masters degreeCONTACT00201155859990 hebatallamaged@med.asu.edu.eg

Hebatalla M Ahmed, Masters DegreePRINCIPAL INVESTIGATOR

MeSH Terms

Interventions

MidazolamKetamineDexmedetomidine

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazoles

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

April 9, 2026

Study Start

November 20, 2025

Actual (reported)

Primary Completion

November 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Midazolam - Ketamine Group

Dexmedetomidine

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Midazolam - Ketamine Group

Dexmedetomidine

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations