Comparing the effect of drug combinations Dexmedetomidine and Fentanyl with Midazolam and Fentanyl through intranasal route in children to make them calm and comfortable before surgery
Phase 4
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/05/067484
- Lead Sponsor
- Dr Nishtha Vij
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All patients of age group (2-6) years ASA grade 1 undergoing elective surgery under general anesthesia with supraglottic airway device or endotracheal tube
Exclusion Criteria
1. Patients with active upper airway disease
2. Patients with known allergy to study drug
3. Patients at risk for airway obstruction
4. Patients with neurodevelopmental delay
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare ease of parental separation in children undergoing elective surgery by premedication with intranasal combinations of Fentanyl and Dexmedetomidine with intranasal Fentanyl and Midazolam.Timepoint: Parental separation assessed once at (30-60) minutes post drug intervention.
- Secondary Outcome Measures
Name Time Method Assessment of: <br/ ><br>1. Preoperative sedation using 4 point sedation scale <br/ ><br>2. Mask acceptance using mask acceptance scale <br/ ><br>3. Post operative analgesia using FLACC Scale <br/ ><br>4. Recovery profileTimepoint: 1.Pre op sedation scale measured once at baseline pre-operatively. <br/ ><br>2. Mask acceptance scale measured once at baseline during induction. <br/ ><br>3.FLACC Scale measured post operatively at baseline, 15 minutes,30 minutes, 45 minutes, 60 minutes. <br/ ><br>4. Recovery profile once post operatively.