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.
Phase 1
- Conditions
- Health Condition 1: N289- Disorder of kidney and ureter, unspecified
- Registration Number
- CTRI/2020/05/025229
- Lead Sponsor
- Dr Aarti Agarwal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
•Children between 2-12 years of age
•Weight < 20 kg
•ASA I and II
•Scheduled for elective surgery
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method separation anxiety via parental separation anxiety score <br/ ><br>Grade 1: Easy separation Grade 2: Whimpers, but is easily reassured, not clinging <br/ ><br>Grade 3: Cries and cannot be easily reassured, but not clinging <br/ ><br>Grade 4: Crying and clinging to parents <br/ ><br>Timepoint: 20 minutes after nasal drug instillation.
- Secondary Outcome Measures
Name Time Method Facemask acceptance <br/ ><br>1.With crying <br/ ><br>2.Without crying <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 20 minutes after nasal drug instillation.;IV Cannulation <br/ ><br>1: Poor (Terrified and Crying) <br/ ><br>2: Fair (Fear of needle, Not reassured) <br/ ><br>3: Good (slight fear of needle, easily reassured) <br/ ><br>4: Excellent (unafraid, accepts IV cannulation readily) <br/ ><br>Timepoint: 20 minutes after nasal drug instillation.;Salivation <br/ ><br>1. Requiring suctioning <br/ ><br>2. Not requiring suctioning <br/ ><br> <br/ ><br>Timepoint: 20 minutes after nasal drug instillation.;Sedation score <br/ ><br>1: Agitated <br/ ><br>2: Awake <br/ ><br>3: Drowsy <br/ ><br>4: Asleep <br/ ><br>Timepoint: 20 minutes after nasal drug instillation.