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Giving midazolam drug which is used to calm and sedate vs fentanyl drug which is used for pain relieving and sedation through nebulisation for those who is undergoing general Aneasthesia surgery in age group of 2 to 8 years

Comparison of effects of nebulised midazolam versus nebulised fentanyl as a premedication in the age group of 2 to 8 years of children undergoing general Aneasthesia - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/12/078654
Enrollment
60
Registered
2024-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: K318- Other specified diseases of stomach and duodenum

Interventions

Control Intervention1: Drug Midazolam Vs Drug Fentanyl: comparing the agent drug Midazolam versus Fentanyl in nebulized format as a premedication agent before undergoing the general anesthesia procedu

Sponsors

Dr Poornima Sonkamble
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children of age group 2 to 8 years with physical status American Association of Anesthesiology (ASA) Class I and Class II. 2. Children belonging to either sex. 3. Children not having a history of: a. Upper airway disease b. CNS dysfunction 4. No Allergy to the drugs under study 5. Children’s undergoing general anesthesia 5. All children with guardian/parents who give consent to take the premedication. 6. Patients with no intranasal pathology or children with airway congenital anomaly.

Exclusion criteria

Exclusion criteria: 1. Children physical status American Association of Anesthesiology (ASA) Class III and Class IV 2. Children with pre-existing cardiovascular, renal, and hepatic disorders, Diabetes mellitus 3. Children known to have allergic reaction to opioids drugs. a. Children allergic to either of study drugs b. Patients with any intranasal pathology or children with any congenital anomaly. c. Children refused to take the premedication due to any reasons.

Design outcomes

Primary

MeasureTime frame
Primary objective- to evaluate. i.Onset and Duration of Sedation. ii.Acceptance of Mask and Other Non-Invasive Maneuver. iii.Onset of Decrease of the Stress Response. Timepoint: Primary objective- to evaluate. i.Onset and Duration of Sedation. ii.Acceptance of Mask and Other Non-Invasive Maneuver. iii.Onset of Decrease of the Stress Response. Secondary objective- to evaluate. i.Hemodynamic variables (Heart Rate, Blood Pressure, O2 saturation)

Secondary

MeasureTime frame
Secondary objective- to evaluate. i. Hemodynamic variables (Heart Rate, Blood Pressure, O2 saturation) Timepoint: Every 10 min

Countries

India

Contacts

Public ContactDr Poornima Sonkamble

JJ Hospital

pathadepoornima@rediffmail.com9850961195

Outcome results

None listed

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