NCT04156334 - 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)

Patini R, Staderini E, Cantiani M, Camodeca A, Guglielmi F, Gallenzi P
Dental anaesthesia for children - effects of a computer-controlled delivery system on pain and heart rate: a randomised clinical trial. Br J Oral Maxillofac Surg. 2018 Oct;56(8):744-7
Townsend JA, Ganzberg S, Thikkurissy S
The effect of local anesthetic on quality of recovery characteristics following dental rehabilitation under general anesthesia in children. Anesth Prog. 2009 Winter;56(4):115-22. doi: 10.2344/0003-3006-56.4.115.

The Effect of Two Local Anaesthesia Techniques on the Paediatric Patient's Recovery After Dental Treatment in General Anaesthesia

Clinical trial NCT04156334 - References