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Evaluation of buccal midazolam in comparison with intranasal midazolam sedation in uncooperative children during dental treatment.

Evaluation of the efficacy of buccal midazolam in comparison with intranasal midazolam sedation in uncooperative children during dental treatment.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000945527
Enrollment
40
Registered
2024-08-05
Start date
2021-05-12
Completion date
2022-06-30
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Behavioral management techniques are not always sufficient, and then it is necessary to use pharmacological management methods. Intranasal midazolam sedation is effective in the management of children during dental treatment, buccal midazolam sedation is more tolerated and acceptable by children than intranasal way. To compare the effectiveness of buccal midazolam sedation with intranasal midazolam in uncooperative children during dental treatment, a sample consisted of 40 children aged 3 to 6 years who were divided randomly into two groups: Group A intranasal midazolam and Group B buccal midazolam. The onset time of action and recovery time from sedation were compared between the two groups, the efficacy of sedation was evaluated by Houpt behavior scale. There were no statistically significant differences in the onset time of action and recovery time from sedation. There were no statically significant differences between the two groups in sleep, crying, and movement categories, or in the overall Houpt scale, there were statistically significant differences in the sleep variable between the two studied phases in the intranasal group (p=0.014), and in the movement variable in the buccal group (p=0.039). Conclusion: both intranasal and buccal midazolam sedation were effective in the management of uncooperative children during dental treatment, in a percent of 85% in the buccal group and 80% in the intranasal group.

Interventions

Brief name: midazolam sedation. The children received undiluted midazolam (5mg/ml) in a dose of 0.3 mg/kg. In group A, intranasal midazolam was sprayed into both nostrils using a mucosal atomizing device (MAD) (MAD 300, Teleflex medical Inc., USA). the intervention is applied relative to dental treatment: before dental treatment, the level of sedation was considered appropriate for treatment when the patient seemed relaxed or when he showed delaying in speech and in response for commands. the i

Brief name: midazolam sedation. The children received undiluted midazolam (5mg/ml) in a dose of 0.3 mg/kg. In group A, intranasal midazolam was sprayed into both nostrils using a mucosal atomizing device (MAD) (MAD 300, Teleflex medical Inc., USA). the intervention is applied relative to dental treatment: before dental treatment, the level of sedation was considered appropriate for treatment when the patient seemed relaxed or when he showed delaying in speech and in response for commands. the intervention drug administered by the dentist, strategies used to monitor adherence : direct observation.

Sponsors

University of Damascus
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

The patient is classified as The American Society of Anesthesiologists (ASA) physical status classification system (I and II), patient’s behavior is within the second degree (negative) of the Frankle scale, and the patient needs a dental treatment which includes pulpotomy for a lower molar.

Exclusion criteria

A patient who refused to participate in the study, the known hypersensitivity to midazolam, upper respiratory tract infection or tonsillar hypertrophy, children with aggressive behavior or high resistance for treatment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026