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Dexmedetomidine versus Fentanyl as Premedication in Pediatric Patients in general anaesthesia

A comparative study of the efficacy of Dexmedetomidine versus Fentanyl as Premedication in Pediatric Patients via intranasal mucosal atomization device. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080412
Enrollment
60
Registered
2025-02-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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: 1.5 ug/kg dose given to the patient 30 min prior surgery and observe the response Control Intervention1: Fentanyl: 1 ug/kg dose given to patient 30 min prior to surgery

Sponsors

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children in the age group 3–12 years ASA I and II. Children undergoing elective surgery under general anesthesia.

Exclusion criteria

Exclusion criteria: Children with ASA physical status Classes III and IV Allergy to the drugs under study Patients with any intranasal pathology/congenital anomaly of upper airway tract Patients on anticonvulsant therapy or other sedative medications Patients undergoing emergency surgeries. Children with bradycardia Patient fulfilling the above said inclusion criteria will be subjected to study.

Design outcomes

Primary

MeasureTime frame
This study will help us to know which drug out of two drugs - intranasal fentanyl or dexmedetomidine is a better premedication to achieve the better-quality sedation and reducing preoperative anxiety in childrenTimepoint: every 5 min till 30 min (pre ot) every 30 min till 2 hours (intra ot)

Secondary

MeasureTime frame
following parameters will be assessed. 1)Anxiety score 2)acceptance of drug 3)level of sedation 4)behaviour at the time of parent separation Timepoint: every 5 min till 30 min (pre ot) every 30 min till 2 hours (intra ot)

Countries

India

Contacts

Public ContactDr Priya Kishnani

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

drpriya0809@gmail.com9898076139

Outcome results

None listed

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