NCT04608734 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

al-Rakaf H, Bello LL, Turkustani A, Adenubi JO
Intra-nasal midazolam in conscious sedation of young paediatric dental patients. Int J Paediatr Dent. 2001 Jan;11(1):33-40.
Chopra R, Marwaha M
Assessment of buccal aerosolized midazolam for pediatric conscious sedation. J Investig Clin Dent. 2015 Feb;6(1):40-4. doi: 10.1111/jicd.12062. Epub 2013 Dec 20.
Houpt MI, Weiss NJ, Koenigsberg SR, Desjardins PJ
Comparison of chloral hydrate with and without promethazine in the sedation of young children. Pediatr Dent. 1985 Mar;7(1):41-6.
Kupietzky A, Holan G, Shapira J
Intranasal midazolam better at effecting amnesia after sedation than oral hydroxyzine: a pilot study. Pediatr Dent. 1996 Jan-Feb;18(1):32-4.
Kupietzky A, Houpt MI
Midazolam: a review of its use for conscious sedation of children. Pediatr Dent. 1993 Jul-Aug;15(4):237-41. Review.
Primosch RE, Guelmann M
Comparison of drops versus spray administration of intranasal midazolam in two- and three-year-old children for dental sedation. Pediatr Dent. 2005 Sep-Oct;27(5):401-8.

Efficacy of Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Dental Patients

Clinical trial NCT04608734 - References