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Comparison of two different routes of administration of dexmedetomidine with oral ketamine to relieve anxiety before operation in young children

Comparison of two different routes of administration of dexmedetomidine (intranasal and nebulised ) alongwith oral ketamine as a premedication in Children 1-5 years of age undergoing elective surgery - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038091
Enrollment
70
Registered
2021-11-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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: dexmedetomidine (intranasal and nebulised ) alongwith oral ketamine as a premedication: Comparison of two different routes of administration of dexmedetomidine (intranasal-2ug/kg, and n

Sponsors

Adesh institute of Medical sciences ResearchBathinda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 1-5 years 2. Both genders 3. ASA grade 1,2 4. Paediatric patient undergoing below umbilical surgery 5. Non-emergency surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: 1. Age >5 years 2. Non assenting parents for their child 3. Known sensitivity to ketamine or dexmedetomidine, 4. Paediatric patient of ASA Grade 3,4 5. Any known congenital heart diseases, raised intracranial pressure, raised intraocular pressure or mental retardation.

Design outcomes

Primary

MeasureTime frame
1. Sedation score 2. Parental separation anxiety scale 3. Medication and mask acceptance scale 4. Recovery time 5. FLACC scale 6. Consolability scale 7. Emergence agitation scale 8. Wong baker scale 9. Modified aldrete score Timepoint: Intranasal or nebulised dexmedetomidine will be given with ketamine and time will be noted at that time and after every 10 min till 30 min T0- time just before giving premedication and noting down vital parameters T1- time of giving premedication T2- time after 10 minutes of premedication and assessing sedation scale T3- time after 20 minutes of premedication T4- time after 30 minutes of premedication and shifting the patient to OT—

Secondary

MeasureTime frame
1. Sedation score 2. Parental separation anxiety scale 3. Medication and mask acceptance scale 4. Recovery time 5. FLACC scale 6. Consolability scale 7. Emergence agitation scale 8. Wong baker scale 9. Modified aldrete score Timepoint: T5- time 4 hours after completion of surgery, see for any post operative pain and adverse event T6- time 8 hours after completion of surgery, see for any post operative pain and adverse event T7- time 12 hours after completion of surgery, see for any post operative pain and adverse event—

Countries

India

Contacts

Public ContactDr Upinder kaur

Adesh institute of Medical sciences & Research,Bathinda

upindermander01@gmail.com9815033776

Outcome results

None listed

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