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Comparing the effect of drug combinations Dexmedetomidine and Fentanyl with Midazolam and Fentanyl through intranasal route in children to make them calm and comfortable before surgery

Comparison of premedication with intranasal Dexmedetomidine and Fentanyl combination with Midazolam and Fentanyl combination in children - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067484
Enrollment
60
Registered
2024-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Fentanyl and Dexmedetomidine: dose-Fentanyl-2mcg/kg, Dexmedetomidine-1 mcg/kg frequency-once before surgery route of administration- Intranasal total duration of intervention- (30-60)mi

Sponsors

Dr Nishtha Vij
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients of age group (2-6) years ASA grade 1 undergoing elective surgery under general anesthesia with supraglottic airway device or endotracheal tube

Exclusion criteria

Exclusion criteria: 1. Patients with active upper airway disease 2. Patients with known allergy to study drug 3. Patients at risk for airway obstruction 4. Patients with neurodevelopmental delay

Design outcomes

Primary

MeasureTime frame
To compare ease of parental separation in children undergoing elective surgery by premedication with intranasal combinations of Fentanyl and Dexmedetomidine with intranasal Fentanyl and Midazolam.Timepoint: Parental separation assessed once at (30-60) minutes post drug intervention.

Secondary

MeasureTime frame
Assessment of: 1. Preoperative sedation using 4 point sedation scale 2. Mask acceptance using mask acceptance scale 3. Post operative analgesia using FLACC Scale 4. Recovery profileTimepoint: 1.Pre op sedation scale measured once at baseline pre-operatively. 2. Mask acceptance scale measured once at baseline during induction. 3.FLACC Scale measured post operatively at baseline, 15 minutes,30 minutes, 45 minutes, 60 minutes. 4. Recovery profile once post operatively.

Countries

India

Contacts

Public ContactDr Nishtha Vij

VMMC and Safdarjung Hospital

jeetendrabajaj@gmail.com9810465070

Outcome results

None listed

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