A comparison of the sedative effect of oral versus nasal midazolam combined with nitrous oxide in uncooperative children.
OBJECTIVE
To compare a combination of oral midazolam (0.2 mg/kg body weight) and nitrous oxide-oxygen sedation with a combination of intranasal midazolam (0.1 mg/kg body weight) and nitrous oxide-oxygen sedation for effectiveness, patient acceptability and safety profile in controlling the behaviour of uncooperative children.


METHODS
Thirty children, 4-10 years of age, referred for dental treatment were included in the study with a crossover design. Each patient was sedated with a combination of either oral midazolam and nitrous oxide-oxygen sedation or intranasal midazolam and nitrous oxide-oxygen sedation at subsequent dental treatment visits. During the treatment procedure, the study recorded scales for drug acceptability, onset of sedation, acceptance of nasal mask, sedation, behavioural, safety, overall behaviour and alertness.


RESULTS
The grade of acceptability of midazolam in both groups was consistently good. There was a significant difference (p < 0.001) in the time of onset of sedation, which was significantly quicker with the intranasal administration of midazolam. The mean time of onset for oral midazolam was 20.1 (17-25) min and for intranasal midazolam 12.1 (8-18) min. The efficacy profile of the present study included: acceptance of nasal mask, sedation score, crying levels, motor movements and overall behaviour scores. The results did not show any statistically significant differences. All the parameters were highly satisfactory. The difference in alertness was statistically significant (p value <0.05), being higher in the intranasal group than the oral group and suggestive of faster recovery using intranasal midazolam.


CONCLUSIONS
The intranasal route of midazolam administration has a quick onset of action and a quick recovery of the patient from sedation as compared to the oral route of midazolam administration. Midazolam administered through the intranasal route is as effective as the oral route at a lower dosage. Therefore, it is an effective alternative to oral route for a paediatric dental situation.
Department of Pediatric and Preventive Dentistry, M.A. Rangoonwala Dental College and Research Centre, Pune, 2390-B, K.B. Hidayatullah Road, Azam Campus, Camp, Pune, 411001, Maharashtra, India.
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Musani
Department of Pediatric and Preventive Dentistry, M.A. Rangoonwala Dental College and Research Centre, Pune, 2390-B, K.B. Hidayatullah Road, Azam Campus, Camp, Pune, 411001, Maharashtra, India. neha.chandan@hotmail.com.
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http://orcid.org/0000-0001-8804-5710
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Chandan
D000281:Administration, Intranasal; D000284:Administration, Oral; D000762:Anesthesia Recovery Period; D000766:Anesthesia, Dental / Q000295:instrumentation; D018685:Anesthetics, Inhalation / Q000008:administration & dosage*; D032763:Behavior Control; D002648:Child; D002652:Child Behavior / Q000187:drug effects; D002675:Child, Preschool; D016292:Procedural Sedation / Q000295:instrumentation / Q000379:methods*; D003299:Cooperative Behavior; D018592:Cross-Over Studies; D003448:Crying; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D008297:Male; D008397:Masks; D008874:Midazolam / Q000008:administration & dosage*; D009068:Movement; D009609:Nitrous Oxide / Q000008:administration & dosage*; D012449:Safety; D013997:Time Factors; D014851:Wakefulness / Q000187:drug effects
D018685:Anesthetics, Inhalation; D006993:Hypnotics and Sedatives; D009609:Nitrous Oxide; D008874:Midazolam
Behaviour management; Intranasal midazolam; Local anaesthetic; Nitrous oxide; Oral midazolam; Uncooperative children