A clinical trial to study the effects of four combinations of drugs for Procedural Sedation and Analgesia in Paediatric dental patients.

Phase 4

• Conditions: Health Condition 1: K00-K14- Diseases of oral cavity and salivary glands

• Registration Number: CTRI/2021/02/030932
• Lead Sponsor: Dr Agarwal Abhilasha Kishanlal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Patients requiring any invasive dental treatment.

2)Patients who are rated as positive and negative on Frankelâ??s behaviour rating scale.

3)Patients of physical status American Society of Anesthesiologists (ASA) class I and II.

4)Signed informed consent by the parents/guardians.

Exclusion Criteria

1)Patients of physical status American Society of Anesthesiologists (ASA) Class III and IV.

2)Patients who have a history of any systemic diseases, like cardiorespiratory dysfunction and CNS dysfunction.

3)Patients who are allergic to any of the drugs considered for the present study or history of any adverse reactions to anesthetic/ sedative agents.

4)Patients with any intranasal pathology, nasal obstruction (obstructive sleep apnea) or with any congenital anomaly.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Evaluation of the onset of sedation and duration of action of different combinations of drugs used for procedural sedation and analgesia. <br/ ><br>2)Evaluation of the depth of sedation in patients during treatment under procedural sedation and analgesia.Timepoint: During the time of treatment.

Secondary Outcome Measures

Name	Time	Method
1)Evaluation of hemodynamic parameters (like blood pressure, heart rate and oxygen saturation) of patients before, during and after undergoing dental treatment under procedural sedation and analgesia. <br/ ><br>2)Behaviour changes in patients during treatment under procedural sedation and analgesia. <br/ ><br>3)Observing relief in pain of patients during invasive dental procedure under procedure sedation and analgesia. <br/ ><br>4)Comparing the ease of treatment completion under procedural sedation and analgesia.Timepoint: During the time of treatment.