NCT03421795 - 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)

Breau LM, MacLaren J, McGrath PJ, Camfield CS, Finley GA
Caregivers' beliefs regarding pain in children with cognitive impairment: relation between pain sensation and reaction increases with severity of impairment. Clin J Pain. 2003 Nov-Dec;19(6):335-44.
Chen-Lim ML, Zarnowsky C, Green R, Shaffer S, Holtzer B, Ely E
Optimizing the assessment of pain in children who are cognitively impaired through the quality improvement process. J Pediatr Nurs. 2012 Dec;27(6):750-9. doi: 10.1016/j.pedn.2012.03.023. Epub 2012 Apr 10. Review.
Dubois A, Capdevila X, Bringuier S, Pry R
Pain expression in children with an intellectual disability. Eur J Pain. 2010 Jul;14(6):654-60. doi: 10.1016/j.ejpain.2009.10.013. Epub 2009 Dec 5.
Genik LM, McMurtry CM, Breau LM, Lewis SP, Freedman-Kalchman T
Pain in Children With Developmental Disabilities: Development and Preliminary Effectiveness of a Pain Training Workshop for Respite Workers. Clin J Pain. 2018 May;34(5):428-437. doi: 10.1097/AJP.0000000000000554.
Genik LM, McMurtry CM, Breau LM
Caring for children with intellectual disabilities part 1: Experience with the population, pain-related beliefs, and care decisions. Res Dev Disabil. 2017 Mar;62:197-208. doi: 10.1016/j.ridd.2017.01.020. Epub 2017 Feb 14.
Twycross A, Williams A
Establishing the validity and reliability of a pediatric pain knowledge and attitudes questionnaire. Pain Manag Nurs. 2013 Sep;14(3):e47-53. doi: 10.1016/j.pmn.2011.03.001. Epub 2011 Apr 17.

Let's Talk About Pain: A Randomized Controlled Trial Testing the Effectiveness of a Pain Assessment and Management Training Program for Respite Workers Supporting Children With Intellectual and Developmental Disabilities

Details for clinical trial NCT03421795

Clinical trial NCT03421795 - References