Notice of Intent to Publish a Notice of Funding Opportunity for the HEAL Initiative: KIDS Acute Pain Clinical Trials (APCT) Program (U01 Clinical Trial Required)

Key Dates

• May 25, 2023 - Notice of Intent to Publish a Notice of Funding Opportunity for the HEAL Initiative: KIDS Acute Pain Clinical Trials (APCT) Program (U24 Clinical Trial Required). See Notice NOT-HD-23-016

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

As part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and participating NIH Institutes and Centers (ICs) intend to publish a Notice of Funding Opportunity (NOFO) to support research that aligns with one of the research goals of the NIH HEAL Initiative to support new clinical trial programs and the expansion of existing programs to evaluate innovative therapies for pain management. The HEAL KIDS (Knowledge, Innovation and Discovery Studies) Pain initiative will be comprised of interrelated programs addressing critical needs in pediatric pain research. This Notice of Intent to Publish announces plans to support the Acute Pain Clinical Trials (APCT) program, focusing on research to improve the assessment, management, and treatment of acute pain in pediatric patients in various health care settings through innovative multi-site clinical trials while integrating relevant behavioral and social influences and contexts on pain experience. 

NICHD intends to utilize a cooperative agreement activity code (U01) for this NOFO. The HEAL KIDS Pain NOFO is anticipated to be published in Summer 2023 with an expected application due date in Fall 2023. Anticipated details of the planned APCT Program are provided below.

Pain in infants, children, and adolescents is common, often under-recognized, inconsistently assessed or measured, and inadequately treated. Moreover, the relationship between pain and human development and any potential effects of repeated pain experiences and opioid pain management on future pain and opioid physical dependency remain largely understudied. Few guidelines related to acute pain in pediatric populations exist, mainly due to a lack of rigorous generalizable data to inform evidence-based practice guidelines, especially in pre-verbal, non-verbal, and unconscious/unresponsive pediatric patients.  Integration of behavioral and social sciences in pain research is also critical to fully understanding pain experiences, addressing disparities, and developing effective interventions. The overall goal of the HEAL KIDS Pain initiative is to move the field of pediatric pain research forward, including fostering a team science approach to addressing knowledge gaps in pediatric pain research.  This Notice encourages investigators with the experience, knowledge, and skills needed to assess, manage, and treat acute pain in pediatric patients through clinical trials to begin to consider applying for the NOFO. 

The overall goal of the APCT Program is to support multi-site clinical trials that seek to establish or implement systematic and/or multimodal approaches for the diagnosis, assessment, and effective treatment of acute pain for pediatric patients across the continuum of care (including pre-hospital settings, outpatient clinic or urgent care, dental clinics, emergency departments, neonatal and pediatric intensive care units, and acute care/hospital facilities). Innovative, groundbreaking, large-scale, multi-site clinical trials focused on improving the assessment, management, and treatment of acute pain in pediatric patients, including acute flares of chronic conditions, are of high programmatic interest.

Proposed APCT trials may include the entire age spectrum of pediatric patients that experience acute pain and may include randomized controlled efficacy, effectiveness, or pragmatic designs and include patient and/or parent-reported outcomes using validated measures. Pharmacological studies to address the limited evidence for the dosing and efficacy of different classes of analgesics to manage acute pain in pediatric patients, as well as dissemination and implementation research clinical trials that could inform acute pain treatment consensus guidelines through the continuum of care are also considered within scope.

As part of the HEAL KIDS Pain initiative, the APCT Program will support studies that integrate relevant behavioral and social influences and contexts on pain experiences. These may include, but are not limited to, inclusion of social determinants of health, social and other influences on the incidence, severity, temporality, and treatment of pain, the impact on perception and experience of pain, and the influences on pain reporting. The reciprocal impact on families and caregivers of pain experiences and reporting is also of interest.

All APCT supported trials will need to include all the appropriate pediatric measures included in the HEAL Pain Common Data Elements (https://heal.nih.gov/data/common-data-elements). Investigators can use these or other validated measures for the trial primary outcome.  

Applications should ensure management and treatment of acute pain is both ethical and equitable for all children regardless of race, ethnicity, sex or gender, socioeconomic level, intellectual and physical disabilities, access to healthcare, and/or proficiency with the English language.

Examples of pediatric pain research foci of interest include but are not limited to: 

• Conducting pharmacological studies to address the limited evidence for the dosing, safety, and efficacy of different classes of analgesics to manage acute pain in pediatric patients
• Studies to develop evidence-based opioid weaning protocols and appropriate pharmacological methods for treating physiologic opioid dependency in pediatric patients
• Studies to develop generalizable scientific data to support multimodal approaches for acute pain management in the pediatric patient population (e.g., developing evidence for multimodal analgesia, which is the current pharmacologic approach despite lack of scientific foundation)
• Studies to evaluate and clinically validate age-appropriate measures, tools, and technologies for the assessment of acute pain across the continuum of care.

Additional outcomes or secondary aims may include:

• Generation of data, methods, and/or tools to support evidence-based management (pharmacological, non-pharmacological, or multi-component) of acute pain in pediatric patients (pre-hospital; emergency departments; neonatal and pediatric intensive care units; dental clinics; inpatient and outpatient)
• Challenges in assessing acute pain in pre-verbal, non-verbal, unconscious/unresponsive pediatric patients, including those with intellectual disabilities 

This Notice is being provided for informational purposes to allow potential applicants additional time to develop responsive applications. NIH reserves the right to modify the scope and objectives as described in this Notice. Final scope, objectives, and requirements will be set forth in the published NOFO. 

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Perdita Taylor-Zapata, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9584
Email: taylorpe@mail.nih.gov

Tammara L. Jenkins, MSN, RN, PCNS-BC, FCCM
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6837
Email: tjenkins@mail.nih.gov