Oral midazolam or intranasal dexmedetomidine in paediatric dental treatment

Phase 4

Completed

Conditions: restorative procedures (RCT, tooth extractions, fillings etc.) of less than 45mins of duration

Registration Number: CTRI/2014/01/004335

Lead Sponsor: Post Graduate Institute of Medical Education and Research

Brief Summary: Sedation is frequently desired in young childrenundergoing day-care dental treatments.Conscious sedation is a safe techniquewhich offers sedation, relief of pain and anxiety with minimal systemic risks.Midazolam is the conventionally used sedative in a wide variety of applications.exmedetomidine is a newer alpha-2 agonist which provides sedation, analgesiaand anxiolysis and has been used intravenously for pediatric proceduralsedation in a variety of settings such as radiological imaging (MRI, CT Scan),awake craniotomies and cardiac catheterization.We planned this study to comparethe efficacy of intranasal Dexmedetomidine with oral Midazolam for sedation inuncooperative children undergoing restorative dental procedures between 2-6years of age. After institutional ethics committee approval, and writteninformed consent from parents, uncooperative children aged 2-6years wereselected from the outpatient department of Oral Health Centre of our Institute.Only those children who were scheduled for restorative procedures (RCT, tooth extractions,fillings etc.) of less than 45mins of duration were enrolled for the study.Children were randomly assigned to two groups for premedication usingcomputer-generated random number chart 20 mins after EMLA cream application. **Group D** received intranasal Dexmedetomidine 2.5mcg/kg, (half thetotal dose loaded in a 2cc syringe undiluted in each nostril) and 5ml oralhoney, as control. **Group M** receivedoral Midazolam 0.5mg/kg mixed with 5 ml honey and sterile water nasal drops (ina 2cc syringe equal volume in both nostrils) as control. IV cannulation wasattempted 30 minutes after premedication at the site pre-treated with EMLAcream. The children were then shifted to the dental chair and the childâ€™sbehavior during dental procedure was assessed using Houptâ€™s behavior ratingscale of movement. A score of 3 was accepted as favourable. To score theoverall behavior and outcome of treatment The Houptâ€™s overall behavior ratingscale was used (Appendix 3).The optimum score which was to be achieved was >3.A score of 5/6 was considered as the best score. IV Ketamineboluses 0.5mg/kg were given till optimal sedation for the procedure is achieved*.* The duration of procedure and thetotal dose of the Ketamine administered was recorded.Intra-procedural vitals likeHR, ECG, NIBP and Oxygen Saturation were monitored continuously at regular 10minute intervals.The children were kept in observation area for a period of60minutes after the end of the procedure. At the end of procedure, thedentistâ€™s opinion was obtained for the overall experience in performing theprocedure as either Good/Fair/Bad. The children were then discharged accordingto the modified Aldrette scoring criteria (Appendix 4). A score of 9/10 wasconsidered as the sufficient criteria for discharge. The parents were contactedby making a telephone call in the evening to elicit any untoward effects orabnormality in the behaviour of their child. A note was made of the same, ifany of these was present.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

uncooperative children aged 2-6years who were scheduled for restorative procedures (RCT, tooth extractions, fillings etc.) of less than 45mins of duration.

Exclusion Criteria

Patients with previous exposure to dental sedation, neurodevelopmental anomalies, abnormal cardiac anatomy, Craniofacial anatomical defects , allergy to EMLA cream, allergy to study drugs.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose of ketamine required to keep acceptable Houpts scores for procedure	during the 20-30 minutes of proceudre

Secondary Outcome Measures

Name	Time	Method
Ramsay sedation Scores, Heart rate, non invasive blood pressure	Ramsay sedation score-before premedication, and 15 and 30 minutes after premedication, after procedure

Trial Locations

Locations (1): Department of oral health
🇮🇳
Chandigarh, CHANDIGARH, India
Department of oral health
🇮🇳Chandigarh, CHANDIGARH, India
Dr Babita Ghai
Principal investigator
9914209533
ghaibabita@hotmail.com