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Comparison of blood levels and Sedation of Dexmedetomidine through mouth and nose in Children

Comparison of Pharmacokinetics and Sedative Effect of Sublingual and Intranasal Dexmedetomidine in Children: A Double-Blind Randomised Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032511
Enrollment
30
Registered
2021-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa

Interventions

Intervention1: Sublingual Dexmedetomidine: 30 minutes Before anaesthesia sublingual dexmedetomidine will be given Control Intervention1: Intransal Dexmedetomidine: 30 minutes Before anaesthesia intran

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) ASA Grade 1 and 2 Patients. 2)Weight 10 to 30 kg.

Exclusion criteria

Exclusion criteria: 1)Parental refusal 2)ASA III, IV 3)OSA 4)Difficult airway

Design outcomes

Primary

MeasureTime frame
To compare the pharmacokinetics of 2 mcg/kg sublingual and intranasal dexmedetomidine in childrenTimepoint: Forty-five minutes before the induction of anaesthesia up to 120 minutes after surgery.

Secondary

MeasureTime frame
1)To evaluate the onset and duration of sedation with sublingual and intranasal Dexmedetomidine. 2)To evaluate the quality of parental separation and the mask acceptance with sublingual and intranasal Dexmedetomidine 3)To evaluate perioperative operative vitals (HR, SpO2, MAP) with sublingual and intranasal Dexmedetomidine 4)To evaluate perioperative analgesia with sublingual ad intranasal Dexmedetomidine and post-operative recovery score with sublingual and intranasal DexmedetomidineTimepoint: Forty-five minutes before the induction of anaesthesia upto 120 minutes after surgery.

Countries

India

Contacts

Public ContactArmanullah Khan

All India Institute of Medical Sciences

renusinhaagarwal@gmail.com9810305156

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026