To check for acceptance of midazolam and lignocaine through nasal route

Completed

Conditions: Patients who require at least one restoration or extraction of grade II/III mobile primary tooth

Registration Number: CTRI/2020/05/025073

Lead Sponsor: Dr Bhavana I

Brief Summary: Very young children often lack cooperative ability and need to be sedated for extensive dental treatment. Hence a needless and painless route of drug administration may be useful to obtain short-term sedation for diagnostic and painful procedures in uncooperative children which can be achieved by INM which is successfully used in a variety of Pediatric clinical situations.By INM with Lignocaine we can enhance the patientâ€™s physical comfort and safety and to control anxiety and behavior, as well as to allow for the completion of the procedure this will lead better patient compliance

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Frankle behaviour rating scale Class III or IV children will be included Patient without any systemic illness Preoperative heart rate of 55 to 100 beats per minute and Respiratory rate of 14 to 16 beats per minute Maximum blood pressure reading of 140 100 mmHg Patients who require at least one restoration or extraction of grade II or III mobile primary tooth Parents giving consent for the study.

Exclusion Criteria

A history of any systemic disease where benzodiazepam is contraindicated An upper respiratory tract infection with nasal discharge or respiratory distress A history of allergy or intolerance to benzodiazepines.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The results of the present study will provide the dental professionals, the best evidence for co-relation of mode of intranasal sedation using INM with MAD	outcome will be assessed/estimated at the time of adminstration of drug and post op with one day follow up

Secondary Outcome Measures

Name	Time	Method
evaluate and acceptance of INM	outcome will be assessed/estimated at the time of adminstration of drug and post op with one day follow up

Trial Locations

Locations (1): KM Shah Dental College And Hospital
🇮🇳
Vadodara, GUJARAT, India
KM Shah Dental College And Hospital
🇮🇳Vadodara, GUJARAT, India
Dr Bhavana I
Principal investigator
7200330083
bhavana.601@gmail.com