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Comparison of Drugs Dexmedetomidine and Fentanyl Through Nasal Route for Anxiolysis in Children Undergoing Hernia Surgery.

Comparison of Intranasal Dexmedetomidine to the Intranasal Fentanyl as a Premedication in the Children Undergoing Herniotomy- A RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/05/005818
Enrollment
40
Registered
2015-05-26
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- children between age of 2 to 8 years of age with the inguinal hernia posted for elective herniotomy surgery under general anaesthesia.

Interventions

Intervention1: Premedication with intranasal Midazolam or intranasal Dexmedetomidine administered once, 30 minutes before the operation.: Fentanyl Group: The children will be premedicated with Fenta

Sponsors

Dr Rajendra Prasad Medical CollegeTanda Kangra HP
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: children who are ASA1 and ASA2 who are posted for elective herniotomy under general anaesthesia.

Exclusion criteria

Exclusion criteria: • Known allergy to the studied drugs. • Organ dysfunction. • Cardiac dysrrhythmia • Congenital heart disease • Psychotropic medication use and mental retardation • Any nasal disorder that may interfere with nasal administration of drugs as • Recurrent nasal bleeding or nasal masses. • Patients who spit, sniffed or refused intranasal administration of medication were excluded.

Design outcomes

Primary

MeasureTime frame
1.The degree of sedation is assessed by using a 4 point sedation scale. 2. The response to the childâ??parent separation will be assessed.Timepoint: 1. The sedation score assessed every 5 minutes for first 30 minutes after admnstration of drug. 2 child parent separation assessed once at 30 minutes after adminstration of drug.—

Secondary

MeasureTime frame
Heart rate (HR), respiratory rate, oxygen saturation (SpO2), and non invasive blood pressure (NIBP) will be measured. Postoperative adverse effects as nausea, vomiting, increased secretion and bradycardia will be reported.Timepoint: Baseline heart rate (HR), respiratory rate, oxygen saturation (SpO2), and non invasive blood pressure (NIBP) will be measured before and every 5 min after intranasal drug administration for 30 min until transfer to the operating room.—

Countries

India

Contacts

Public ContactUsha Kumari Chaudhary

Dr. Rajendra Prasad Medical College,Tanda,Kangra,HP

chaudhary.ushaarvind@gmail.com9459301813

Outcome results

None listed

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