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Clinical Trial Summary

This is a concept elicitation study to identify important aspects of acute pain assessment, treatment, and response to treatment in infants and young children, age 0 to 3 years old, from a clinician's perspective.


Clinical Trial Description

The purpose of this study is to identify important endpoints and outcomes for use in pediatric trials of acute pain therapeutics in children who are 0 to <3 years of age from a clinician's perspective. To identify these endpoints and outcomes the investigators will conduct remote qualitative concept elicitation interviews with 27 clinicians who treat pediatric patients. These interviews will include verbal consent to participate, a demographics questionnaire, and a semi-structured interview which will last approximately one hour. Interview questions will address the participant's professional experience recognizing and managing pain in children between 0 and 3 years of age. Interviews will be audio recorded and transcribed with the participant's permission. Transcripts and notes will be coded and analyzed. This is a minimal risk study; the investigators are only using standard interview procedures and are not collecting any protected health information from participants. While the investigators do not believe that any information collected would jeopardize the personal or professional standing of participants, all information will be kept strictly confidential per Good Clinical Practice guidelines. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04380246
Study type Observational
Source Duke University
Contact
Status Completed
Phase
Start date August 6, 2020
Completion date December 21, 2020

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