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

Completed

• Conditions: Diseases of the eye and adnexa,

• Registration Number: CTRI/2021/04/032511

Brief Summary

Children prefer pain free, irritation-free methods for administration of premedication. Different drugs with different formulations have been used as premedication like midazolam, clonidine, dexmedetomidine, chloral hydrate, etc. Dexmedetomidine is a highly selective alpha-2-adrenergic agonist with potent anxiolytic sedative and analgesic effects. Dexmedetomidine has been used via buccal, nebulization, sublingual, intranasal, oral, etc, routes for premedication. We are planning to evaluate and compare the pharmacokinetics and sedative effect of sublingual dexmedetomidine with intranasal dexmedetomidine in children.

After doing pre-anaesthetic check-up and obtaining consent, patient will be taken up for study. Intravenous cannulation will be done first to take blood samples at various intervals. Then According to the randomization, 30 minutes before the induction of anaesthesia, anaesthesiologist not involved in the study will administer dexmedetomidine at the dose of 2mcg/kg via the sublingual route in the group sublingual or intranasal route in group intranasal and saline will be administered via intranasal route in the group sublingual or via sublingual route in the group intranasal to maintain blinding. Time and duration of sedation, separation from parents, face mask acceptance for anaesthesia, recovery after anaesthesia and pain relief will be observed at various time intervals.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-04
• Study Completion: 2022-08-19
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1. ASA Grade 1 and 2 Patients.
• 2)Weight 10 to 30 kg.

Exclusion Criteria

1)Parental refusal 2)ASA III, IV 3)OSA 4)Difficult airway.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the pharmacokinetics of 2 mcg/kg sublingual and intranasal dexmedetomidine in children	Forty-five minutes before the induction of anaesthesia up to 120 minutes after surgery.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AIIMS, New Delhi; 🇮🇳 Delhi, DELHI, India

AIIMS, New Delhi

🇮🇳Delhi, DELHI, India

Renu Sinha

Principal investigator

9810305156

renusinhaagarwal@gmail.com