Comparison of three sedative agents; intranasal dexmedetomidine, intranasal midazolam and inhalation nitrous oxide for children undergoing dental treatment

Phase 3

Completed

• Conditions: Dental caries, unspecified,

• Registration Number: CTRI/2022/03/041180
• Lead Sponsor: Janiani Palak Ramesh

Brief Summary

Dental treatment has always been considered as an anxiety-provoking experience for many children. For these children, many different forms and different drugs have been used by operators for their sedation and dental treatment. These commonly include midazolam (i.v, oral or intranasally), dexmedetomidine or nitrous oxide-oxygen. Midazolam is considered as the “ potentially idel sedative agent† with a wide toxic/therapeutic ratio and safety margin. Dexmedetomidine is one of the safest drugs causing least respiratory depression. Nitrous oxide-oxygen is the “standard technique’†used in dental operatories for concious sedation. All 3 agents have their own advantages and comparing them will help us to conclude which is the most effective and safest for paediatric dental treatment. Moreover, intranasal route allows patient to maintain nil per oral and therefore chances of aspiration are very less.

**Aim:**To compare the efficacy of intranasal atomized intranasal dexmedetomidine, atomized midazolam and nitrous oxide-oxygen inhalation for conscious sedation of 6-8 year old anxious children undergoing dental treatment

**Objectives :**

To evaluate & compare:

1. the sedative efficacy of atomized intranasal dexmedetomidine, atomized midazolam and nitrous oxide-oxygen for concious sedation in pediatric dental treatment.

2. the effect on behaviour after the use of atomized intranasal dexmedetomidine, atomized intranasal midazolam and nitrous oxide-oxygen for concious sedation in pediatric dental treatment.

3. the recovery time after administration of  atomized intranasal dexmedetomidine, atomized intranasal midazolam and nitrous oxide- oxygen for concious sedation in pediatric dental treatment.

4. the intra- & post-op pain during treatment after administration of atomized intranasal dexmedetomidine, atomized midazolam and nitrous oxide-oxygen for concious sedation in pediatric dental treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-04
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1.ASA I Category 2.Behavior category: Frankl Scale 2 negative 3.Requiring pulpectomy in at least three posterior teeth in the lower arch 4.No cognitive impairment.

Exclusion Criteria

• 1.Patients who recently used medications like erythromycin or anticonvulsants that may interfere with the pharmacokinetics of midazolam.
• 2.Children with any condition that predisposes them to airway obstruction or difficulties (eg adenoid hyperplasia, nasal septum problems, enlarged turbinates or nasal polyp).
• 3.Frankl scale #1 (definitely negative) 4.Children with upper or lower respiratory tract infections 5.
• Children with special health care needs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra- and Post-op pain	Assessment of sedation and behaviour | Intra- and Post-op pain
Assessment of sedation and behaviour	Assessment of sedation and behaviour | Intra- and Post-op pain

Secondary Outcome Measures

Name	Time	Method
Physiologic signs (Blood pressure, SPO2, Pulse rate)	Recovery time

Trial Locations

Locations (1)

Clinic Number 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College; 🇮🇳 Thiruvallur, TAMIL NADU, India

Clinic Number 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College

🇮🇳Thiruvallur, TAMIL NADU, India

Dr Janiani Palak Ramesh

Principal investigator

9820775554

palakjaniani@gmail.com