NCT03806270 - 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)

Köner O, Türe H, Mercan A, Menda F, Sözübir S
Effects of hydroxyzine-midazolam premedication on sevoflurane-induced paediatric emergence agitation: a prospective randomised clinical trial. Eur J Anaesthesiol. 2011 Sep;28(9):640-5. doi: 10.1097/EJA.0b013e328344db1a.
Oh JN, Lee SY, Lee JH, Choi SR, Chin YJ
Effect of ketamine and midazolam on oculocardiac reflex in pediatric strabismus surgery. Korean J Anesthesiol. 2013 Jun;64(6):500-4. doi: 10.4097/kjae.2013.64.6.500. Epub 2013 Jun 24.

Hydroxyzine Dihydrochloride Premedication is a Necessity for Pediatric Patients Undergoing Strabismus Surgery; An Observational Clinical Trial Controlled With Midazolam

Details for clinical trial NCT03806270

Clinical trial NCT03806270 - References