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To study the efficacy of Midazolam and its combination with ketamine through the nasal route before transferring children from parent company to the operation theatre, who are scheduled for surgery.

Evaluation of efficacy of Intranasal Midazolam and its combination with Intranasal Ketamine as premedication of children scheduled for elective surgery.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025229
Enrollment
72
Registered
2020-05-18
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: N289- Disorder of kidney and ureter, unspecified

Interventions

Intervention1: Group 1 Intranasal Midazolam : Intranasal Midazolam 0.25mg/kg will be given with as nasal instillation, half dose in each nostril. Each instillation will be given at a gap of 30 second

Sponsors

Dr Aarti Agarwal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Children between 2-12 years of age • Weight • ASA I and II • Scheduled for elective surgery

Exclusion criteria

Exclusion criteria: 1. Patientâ??s parent consent refusal 2. Patients with known allergy to any medications, running nose, upper respiratory tract infections, mental retardation, or neurobehavioral problems. 3. Emergency surgery 4. Patient belonging to ASA 3 or 4 group.

Design outcomes

Primary

MeasureTime frame
separation anxiety via parental separation anxiety score Grade 1: Easy separation Grade 2: Whimpers, but is easily reassured, not clinging Grade 3: Cries and cannot be easily reassured, but not clinging Grade 4: Crying and clinging to parents Timepoint: 20 minutes after nasal drug instillation.

Secondary

MeasureTime frame
Facemask acceptance 1.With crying 2.Without crying Timepoint: 20 minutes after nasal drug instillation.;IV Cannulation 1: Poor (Terrified and Crying) 2: Fair (Fear of needle, Not reassured) 3: Good (slight fear of needle, easily reassured) 4: Excellent (unafraid, accepts IV cannulation readily) Timepoint: 20 minutes after nasal drug instillation.;Salivation 1. Requiring suctioning 2. Not requiring suctioning Timepoint: 20 minutes after nasal drug instillation.;Sedation score 1: Agitated 2: Awake 3: Drowsy 4: Asleep Timepoint: 20 minutes after nasal drug instillation.

Countries

India

Contacts

Public ContactDr Neeraj Pal Singh

SGPGIMS, LUCKNOW

aarti_agarwal000@yahoo.co.uk8765974039

Outcome results

None listed

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