COMPARISON OF TWO MILD SLEEP MEDICINES (DEXMEDETOMIDINE GIVEN UNDER THE TONGUE AND MIDAZOLAM GIVEN AS AN ORAL SYRUP)TO CALM CHILDREN JUST BEFORE SURGERY
- Conditions
- Health Condition 1: null- Any child between the ages of 3 years to 7 years, weighing between 10-20 kilograms, undergoing elective minor surgery.
- Registration Number
- CTRI/2017/12/010925
- Lead Sponsor
- Kasturba Hopsital Manipal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
American Society of Anaesthesiologists Physical Status (ASA PS) 1 and 2, Weight 10 to 20 kg, Elective minor surgery under general anesthesia
American Society of Anesthesiologists Physical Status (ASA PS) 3 and 4, Weight < 10 kg or > 20 kg, Known allergy or hypersensitivity to dexmedetomidine, Parental/ Guardian refusal, Severe developmental delay or behavioural problems, Emergency cases, Cardiac arrhythmia or congenital heart disease, Surgeries more than 4 hour duration, Haemodynamic or respiratory instability, Children at risk for airway obstruction (obstructive sleep apnoea or a craniofacial syndrome), Any treatment with sedatives or anticonvulsants, Children who spit, vomited or refused sublingual administration of medication will also be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Behaviour of the child on separation from parent (Modified Observer assessment of alertness and sedation scale- MOAA/S of 3 or 4)Timepoint: At 2 years
- Secondary Outcome Measures
Name Time Method - Acceptability of the drug via sublingual route <br/ ><br>- Mask acceptance (Mask acceptance score of 1 or 2) <br/ ><br>- Behaviour at time of wake-up from anaesthesia (Wake up behaviour score 1 or2) <br/ ><br>Timepoint: At 2 years