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A clinical trial to compare the premedication effect of dexmedetomidine in children by two different routes

Comparison of inhalational versus intranasal dexmedetomidine for premedication in children undergoing elective surgery under general anaesthesia : A prospective , randomised, double blinded study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041448
Enrollment
52
Registered
2022-03-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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: inhalational dexmedetomidine: Children under going elective minor surgeries are divided into two group, study group will receive Dexmedetomidine nebulisation(2ug/kg) using jet nebuliser

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 2 â?? 6 years of both genders 2. American Society of Anesthesiology physical Status (ASA PS) I-II 3. Children undergoing elective minor surgeries under general anaesthesia.

Exclusion criteria

Exclusion criteria: 1.Children with hypotension and bradycardia 2.Known allergy or hypersensitive reaction to study drug 3.Children having congenital heart disease 4.Pre-existing hepatic or renal impairment 5.Children with raised intracranial pressure 6.Children with raised intraocular pressure 7.Children with mental retardation and developmental delay 8. Children with history of prematurity 9.Children guardianâ??s refusal for consent

Design outcomes

Primary

MeasureTime frame
1.To compare the number of children with successful Mask acceptance score between the study groups Timepoint: 1.Assessed 30min after administration of premedication

Secondary

MeasureTime frame
1.To compare level of sedation at the end of 30 minutes after premedication administration 2.To compare premedication acceptance among the study groups 3.To compare parental separation anxiety scale among the study groups 4.To compare the postoperative emergence agitation among the study groups. 5.To compare the side effects between the study groups. Timepoint: 1.Assessed at the end of 30 minutes after premedication administration 2.Assessed at the time of administration of drugs 3.Assessed at the end of 30min while shifting of child to operation room 4.Assessed after shifting the child to PACU at 15 and 30 min in the presence of parents 5.Assessed from the time of administration of drugs and to shifting the child back to the ward.

Countries

India

Contacts

Public ContactDr Priyanka gupta

All India Institute Of Medical Sciences , Rishikesh

priyanka.anaes@aiimsrishikesh.edu.in9811894899

Outcome results

None listed

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