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Comparison of nasal administration of two sedative drugs dexmedetomidine and fentanyl for sedation before surgery in children

Comparison of intranasal dexmedetomidine versus intranasal fentanyl premedication in pediatric patients posted for elective surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013050
Enrollment
88
Registered
2018-04-04
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: null- ASA I/II Patients posted For Elective Surgery

Interventions

Intervention1: Comparison of Intranasal premedication -dexmeditomidine or fentanyl in children: Premedication is given 45 minutes prior to surgery Control Intervention1: Comparison between intranasal

Sponsors

Bhagat Phool Singh Government Medical College For Women
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children of American society of Anesthesiologists (ASA) grade I/II/ patients 2. Age group:- 2 to 10 yrs of age of all genders. 3. Weight 4. Elective surgical procedures under General Anesthesia. 5. Parents and guardian willing to provide their voluntary written informed consent form for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Parents and guardian not willing to participate in the present study. 2. History of allergy and hypersensitivity to dexmedetomidine / fentanyl. 3. Presence of upper respiratory tract infection and nasal pathology. 4. Patients having delayed milestones and who are mentally challenged. 5. Patients with any cardiac/respiratory disease. 6. Surgery lasting for more than 90 minutes will be excluded.

Design outcomes

Primary

MeasureTime frame
1.To determine the time of onset and duration of sedation. 2.To determine the level of anxiety by child parent separation score. 3.To determine post-operative sedation and behavior score Timepoint: 1.Time of onset and duration of sedation in 45 minutes of premedication and 3 hours of post surgery 2.Anxiety by child parent separation score at end of 45 minutes of premedication 3.Post-operative behaviour score at end of surgery 4.post-operative sedation score at the end of surgery and till 3 hours after surgery—

Secondary

MeasureTime frame
1.To determine hemodynamic parameter like heart rate, blood pressure, mean arterial pressure, SpO2 in each group. 2.To determine the side effect in each group if any. Timepoint: In 45 minutes before surgery and intraoperative of maximum 90 minutes—

Countries

India

Contacts

Public ContactMohit Parihar

Bhagat Phool Singh Government Medical College For Women

pranavbansal1@gmail.com8222007555

Outcome results

None listed

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