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Comparing the effect of Dexmedetomidine via two different routes of administration namely intranasal and buccal to help children feel at ease before surgery

Comparison of Intranasal Dexmedetomidine with Buccal Dexmedetomidine for premedication in children undergoing elective surgery - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066909
Enrollment
80
Registered
2024-05-07
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: Dexmedetomidine: Administration and comparison of 1 microgram/kg Intranasal Dexmedetomidine with 1 microgram/kg Buccal Dexmedetomidine 30 to 40 minutes before shifting to operation thea

Sponsors

VMMC and Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients of age between 2-6years belonging to ASA I and II undergoing elective surgery under general anaesthesia with Supraglottic airway device or Endotracheal tube

Exclusion criteria

Exclusion criteria: 1. Patients with known allergy to the study drug 2. Patients with developmental delay 3. Anticipated difficult airway

Design outcomes

Primary

MeasureTime frame
Ease of Parental Separation as primary outcome in children undergoing elective surgery by premedication with Intranasal and Buccal dexmedetomidineTimepoint: At Baseline, 30-40 minutes before surgery—

Secondary

MeasureTime frame
Mask Acceptance ScoreTimepoint: At baseline i.e when patient will be shifted to operation theatre table;Sedation scoreTimepoint: 5 minutes, 10 minutes, 20 minutes,30 minutes after administation of study drug, on arrival in operation theatre, every 15 minutes uptill 1 hour postoperatively—

Countries

India

Contacts

Public ContactDr Sapna Bathla

VMMC and Safdarjung Hospital

sapnapearl@gmail.com9582358200

Outcome results

None listed

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