A clinical trial to study the effects of two drugs, oral midazolam and intranasal dexmedetomidine as premedication in children.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Sedative and anxiolytic effect of oral midazolam syrup and nasal dexmedetomedine on children undergoing minor surgeries will be studied.
- Registration Number
- CTRI/2013/10/004066
- Lead Sponsor
- okamanya Tilak Muncipal Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1.ASA - I & II
2.Minor surgical procedures like Herniotomy, Orchidopexy, Hypospadiasis repair, Split skin grafting, Excision of lumps, Circumcision, Cystoscopy, Excision of lymph nodes etc.
3.Parent consenting for the study
Exclusion Criteria
1.Age < 1 year and age > 12 years
2.ASA III and above
3.Hypersensitivity to midazolam or dexmedetomidine
4.Patients with airway problems
5.Patients with respiratory disorders
6.Patients with cardiovascular disorders
7.Patients with central nervous system disorders
8.Patients with liver, renal and gastrointestinal disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Preoperative sedation <br/ ><br>2.Ease of separation from parents <br/ ><br>3.Quality of mask acceptance <br/ ><br>4.Hemodynamic status <br/ ><br>5.Ease of induction <br/ ><br>6.Post operative sedation <br/ ><br>7.Post operative analgesia <br/ ><br>8.Incidence of post operative nausea, vomiting, agitation and shivering.Timepoint: Preop every 10 min after giving premedication <br/ ><br> <br/ ><br>Intraop at the time of induction & every 5 minutes for first 30 minutes & thence every 10 minutes till the end of surgery: <br/ ><br> <br/ ><br>Post- operatively every 15 minutes for 1st hour & every 30 minutes for another 2 hours. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method OT APPLICABLETimepoint: NOT APPLICABLE