what intranasal dexmedetomidine dose is better in sedation : 2mcg/kg or 3mcg/kg?

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2020/12/029649
• Lead Sponsor: All India Institute of Medical Sciences Raipur

Brief Summary

The importance ofprocedural sedation and analgesia (PSA) for children undergoing diagnostic proceduressuch as imaging studies in CT, MRI suite and for echocardiography has led to anincrease in demand for sedation outside of the operating room. Due to thisdemand, the role of pediatricians, physicians, anaesthesists and emergencyphysicians have also expanded to include PSA. For non-operating roomanesthesia, (NORA) dexmedetomidine offers a safety profile similar totraditional sedatives (i.e., ketamine and midazolam) and has been reported tobe efficacious even when administered intranasally (IN).

We plan to conduct this research as Intranasaladministration of dexmedetomidine may be advantageous for such procedures inpediatric population, as compared to intravenous route as it is shown tohave lesser hemodynamic changes and preserves the airway better, additionally,the fear and anxiety triggered by needles and closed environment are also less.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study Completion: 2021-12-18
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• pediatric patients aged between 1 years and 10 years who are undergoing non-invasive radiological procedures like CT scan, MRI, Ultrasound, echocardiography.
• Belonging to ASA PS grade 1 and 2.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Research Hypothesis: Intranasal Dexmedetomidine 3mcg/kg is more efficient than intranasal dexmedetomidine 2mcg/kg for non-invasive radiological procedural sedation in pediatric age group. Greater efficacy will be established based on sedation level and need of rescue doses of drug.	One year

Secondary Outcome Measures

Name	Time	Method
we assume that, physician’s satisfaction in performing the procedure is better with 3mcg/kg body weight	safety profile of 3mcg/kg body weight dose of Intranasal dexmedetomidine in terms of adverse events (bradycardia, hypotension, desaturation, excessive sedation) is better.

Trial Locations

Locations (1)

All India Institute of Medical Sciences Raipur; 🇮🇳 Raipur, CHHATTISGARH, India

All India Institute of Medical Sciences Raipur

🇮🇳Raipur, CHHATTISGARH, India

Dr Suresh

Principal investigator

9482289473

sureshnagalikar1@gmail.com