Comparing the effect of drug combinations Dexmedetomidine and ketamine with midazolam and ketamine through intranasal route in children to make them calm and comfortable before surgery.
Phase 4
- Registration Number
- CTRI/2024/08/071944
- Lead Sponsor
- Vardhman Mahavir medical college and Safdarjung hospital
- 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 between2 to 6 years belonging to ASA 1 undergoing elective surgery under general Anaesthesia with supraglottic wirway device or endo tracheal tube
Exclusion Criteria
1.Active upper respiratory tract infection
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 dexmedetomidine and ketamine combination with intranasal midazolam and ketamine.Timepoint: Parental separation assesed onceat (30-60) minutes Post drug intervention
- Secondary Outcome Measures
Name Time Method To assess <br/ ><br>1. Preoperative sedation using 4 point sedation scale <br/ ><br>2. Mask acceptance using mask acceptance scale <br/ ><br>3. Emergence delirium after waking up using emergence agitation scale <br/ ><br>4. Post operative analgesia using FLACC scale <br/ ><br>5. Recovery profileTimepoint: 1.Preoperative sedation will be measured once at baseline preoperatively. <br/ ><br>2.Mask acceptance scale measured once at baseline during induction. <br/ ><br>3.FLACC scale measured postoperative at base line ,15 minutes, 30 minutes, 45 minutes, 60 minutes <br/ ><br>4.Emergence agitation scale measured postoperative at baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes <br/ ><br>5.Recovery profile once postoperatively