NCT02350504 - 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)

Alexander M
Managing patient stress in pediatric radiology. Radiol Technol. 2012 Jul-Aug;83(6):549-60. Review.
de Amorim e Silva CJ, Mackenzie A, Hallowell LM, Stewart SE, Ditchfield MR
Practice MRI: reducing the need for sedation and general anaesthesia in children undergoing MRI. Australas Radiol. 2006 Aug;50(4):319-23.
Marshall SP, Smith MS, Weinberger E
Perceived anxiety of pediatric patients to magnetic resonance. Clin Pediatr (Phila). 1995 Jan;34(1):59-60.
Törnqvist E, Månsson Å, Hallström I
Children having magnetic resonance imaging: A preparatory storybook and audio/visual media are preferable to anesthesia or deep sedation. J Child Health Care. 2015 Sep;19(3):359-69. doi: 10.1177/1367493513518374. Epub 2014 Jan 31.
Tyc VL, Fairclough D, Fletcher B, Leigh L, Mulhern RK
Children's distress during magnetic resonance imaging procedures. Child Health Care. 1995 Winter;24(1):5-19.

IMPACT OF CHILDREN&Apos;S PREPARATION BEFORE MRI ON ANXIETY AND NEED FOR ANESTHESIA: A PROSPECTIVE RANDOMIZED CLINICAL TRIAL.

Clinical trial NCT02350504 - References