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To study and compare efficacy of 3 drug groups given as a nasal spray used to reduce anxiety and parenteral separation in children before surgery

To study and compare efficacy of anaesthetic premedication in the form of intranasal dexmedetomidine and ketamine v/s intranasal midazolam v/s intranasal ketamine and midazolam in the paediatric age group - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066745
Enrollment
120
Registered
2024-05-03
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: Intranasal Midazolam: Group M Route-Intranasal Midazolam Dose-0.2mg/kg Frequency- using the atomiser, the prepared drug is administered cautiously in both nostrils Duration-given 30 m

Sponsors

Swami Rama Himalayan University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children in the age group of 2-10 years ASA grade 1 or 2 Either sex Undergoing elective surgery procedures requiring GA with either Endotracheal Tube/Laryngeal mask airway for those patients in which consent has been given

Exclusion criteria

Exclusion criteria: children less than 2 and more than 10 years ASA grade more than 2 emergency surgeries known allergies to the above mentioned drugs developmental delays/mental retardation history of sedative/analgesic intake history of congential heat disease/arrythmias case of URTI significant nasal discharge/obstruction severe trauma of nose

Design outcomes

Primary

MeasureTime frame
parental separation anxiety based on a 4 point scoring system Timepoint: time interval taken to achieve a parental separation score of more than or equal to 2 as a desirable parameter

Secondary

MeasureTime frame
mask acceptance intraop opiod use post op agitation post op emergence delirium post op nausea and vomitingTimepoint: intraop till end of surgery post op till 30 mins for agitation and 24 hours for rest

Countries

India

Contacts

Public ContactTanmaya Sachdeva

Swami Rama Himalayan University

priyarkrishnan@srhu.edu.in9149225153

Outcome results

None listed

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