Skip to content

Comparison between two drugs fentanyl and dexmedetomidine given from nose before surgery in pediatric patients undergoing general anaesthesia to alleviate anxiety.

Comparison of fentanyl v/s dexmedetomidine intranasally as premedication in pediatric patients undergoing general anaesthesia:Randomised,double blind,interventional study in S.M.S hospital Jaipur during 2019-2020

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026763
Enrollment
60
Registered
2020-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa

Interventions

Intervention1: Injection fentanyl: fentanyl 1.5 microgram/kg body weight total calculated dose of which 0.5 ml will be given in each nostril once 30 minutes before starting surgery Control Interventio

Sponsors

Department of anaesthesia SMS medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I and II Patients willing to give written informed consent. Body weight 9-16kg. Patients scheduled to undergo surgery under general anaesthesia.

Exclusion criteria

Exclusion criteria: Patients having known allergy to drugs used in study. Patients having intranasal pathology or congenital anomaly. Children who refused to take premedication. Insane patients Patients taking any medication for sedation, anxiety, analgesia.

Design outcomes

Primary

MeasureTime frame
To determine the difference in duration of onset of anxiolysis and sedation in both groupsTimepoint: Effect of the two drugs on anxiolysis and sedation will be observed from 30 minutes before starting surgery to 2 hours after completion of surgery

Secondary

MeasureTime frame
To determine the difference in hemodynamic parameters(HR,BP) and respiratory depression(SpO2 and RR) induced by two different groups(fentanyl and dexmedetomidine)Timepoint: Observing effect of the drug on hemodynamic and respiratory parameters from 30 minutes before starting surgery to 2 hours after completion of surgery.

Countries

India

Contacts

Public ContactDr Alaka Purohit

SMS medical college

purohitalaka@gmail.com8003399995

Outcome results

None listed

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