Efficacy of intravenous sub-dissociative ketamine versus intravenous morphine in children with acute pain

Active Cooperative Agreement Awarded Last action

Award ID
U01HD116253
Recipient
Awarding agency
Obligated
$13,238,876

Award facts

Assistance listing
93.279 Drug Use and Addiction Research Programs
Completion date 43% complete
Funding agency
National Institute of Neurological Disorders and Stroke National Institutes of Health, Department of Health and Human Services
Place of performance
New York, NY 10032, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Pain is one of the most common reasons for children to visit an emergency department (ED) and is associated with short- and long-term consequences when inadequately treated. Intravenous (IV) morphine is the prototypical and most commonly administered parenteral analgesia for treating moderate to severe acute pain in children. However, IV morphine is associated with acute adverse events such as respiratory depression and hypotension. In addition, there is hesitation amongst caregivers and clinicians to administer opioids to children, leading to withholding or under-dosing analgesics in children with pain and thereby perpetuating the undertreatment of pain and the resulting short- and long-term sequelae. Ketamine is an nmda-antagonist that has the potential to improve both short- and long-term sequelae of acute pain experienced by children presenting to the ED. IV ketamine has been shown to be an effective and safe analgesic when given using sub-dissociative doses to adults with acute pain in the ED or pre-hospital setting. Sub-dissociative ketamine's analgesic efficacy and favorable safety profiles make IT an attractive alternative to morphine. In addition, ketamine may improve pain-related function and decrease potential long-term sequelae of acute painful events such as chronic pain and medication dependency, post-traumatic stress disorder, anxiety and depression. The aims of this study are to demonstrate that IV sub-dissociative ketamine is as effective as IV morphine for treating acute pain in children and that its rate of cardiorespiratory events is substantially less compared to morphine. Additionally, we aim to determine if children who receive ketamine will have better levels of pain-related function during the first week after ED presentation, and have greater odds of experiencing more favorable post-traumatic stress, anxiety and depression outcomes up to 6 months following their ED visit. We will achieve these aims by conducting an 8-site phase 3 randomized clinical trial within the pediatric emergency care applied research network (pecarn) comparing IV sub-dissociative ketamine to IV morphine in children presenting to the ED with acute pain. We will enroll 1010 children 6 to 17 years of age with moderate to severe acute pain and require IV morphine for analgesia. In addition, we will study children who most commonly receive parenteral opioids in the ED, namely those with abdominal pain or extremity fractures. We will collect measures of pain intensity and analgesic efficacy and assess for acute adverse events during the child's ED course and conduct follow-up procedures assessing pain-related function, analgesic use/misuse, mental health and behavioral outcomes up to 6 months after the index ED visit. The findings of this study have the potential to fundamentally change how acute pain is managed in children and improve both their short- and long-term health. Achieving our aims would provide the necessary evidence to inform guidelines and support a transition from morphine to a non-opioid analgesic such as sub-dissociative ketamine as the primary treatment modality for children with moderate to severe acute pain.

Transactions

Action Obligated Date
Amendment $3,193,679
Amendment $3,238,659
Amendment $0
Amendment $0
Amendment $3,403,269
Original award $3,403,269

Subawards

Subrecipient Amount Awarded
University Of Pittsburgh - Of The Commonwealth System Of Higher Education We will conduct an 8-site randomized clinical trial of 1010 children 6 to 17 years old within the Pediatric Emergency Care Applied Research Network (PECARN),… $69,151
University Of California, Davis This study is an 8-site randomized clinical trial of 1010 children 6 to 17 years old within the Pediatric Emergency Care Applied Research Network (PECARN), with… $84,987
Emory University We will conduct an 8-site randomized clinical trial of 1010 children 6 to 17 years old within the Pediatric Emergency Care Applied Research Network (PECARN),… $67,462
Emory University $72,440
The Medical College Of Wisconsin, Inc. $66,512
Wake Forest University Health Sciences The MAP site commits to invite up to 15 participants already enrolled in the MAP study, who are willing and able to undergo brain magnetic resonance imaging… $20,379
The Medical College Of Wisconsin, Inc. Dr. Drendel will have the responsibility of ensuring the successful execution and completion of all study components. Dr. Drendel will work closely with Dr.… $160,306
University Of Utah Bradley John Barney will be a Co-Investigator on the proposed application. He will be responsible for all aspects of the proposed DCC/PECARN EDC activities… $837,167
Seattle Children's Hospital We will conduct an 8-site randomized clinical trial of 1010 children 6 to 17 years old within the Pediatric Emergency Care Applied Research Network (PECARN),… $92,905
Baylor College Of Medicine Leading efforts to ensure inclusive enrollment practices:a. DR. Portillo will be actively engaged in protocol development to ensure optimalstudy design to… $22,193
Children's Hospital LOS Angeles We will conduct an 8-site randomized clinical trial of 1010 children 6 to 17 years old within the Pediatric Emergency Care Applied Research Network (PECARN),… $90,266
Children's Hospital LOS Angeles We will conduct an 8-site randomized clinical trial of 1010 children 6 to 17 year's old within thepediatric emergency care applied research network (pecarn),… $90,266
Baylor College Of Medicine Leading efforts to ensure inclusive enrollment practices: a. Dr. Portillo will be actively engaged in protocol development to ensure optimal study design to… $22,193
Children's Hospital LOS Angeles We will conduct an 8-site randomized clinical trial of 1010 children 6 to 17 year's old within thepediatric emergency care applied research network (pecarn),… $88,102
Seattle Children's Hospital We will conduct an 8-site randomized clinical trial of 1010 children 6 to 17 year's old within thepediatric emergency care applied research network (pecarn),… $31,400
The Nemours Foundation The Nemours Foundation / Nemours Children’s Hospital, Delaware will continue supporting the pediatric acute-pain ketamine versus morphine trial. The Nemours… $85,811
Seattle Children's Hospital We will conduct an 8-site randomized clinical trial of 1010 children 6 to 17 year's old within thepediatric emergency care applied research network (pecarn),… $96,070
Marquette University Marquette University will continue supporting the pediatric acute-pain ketamine versus morphine trial through technical and mHealth support. The Marquette… $63,212
University Of California, Davis The Regents of the University of California, Davis will continue supporting the pediatric acute-pain ketamine versus morphine trial as a PECARN clinical site.… $90,136
Baylor College Of Medicine Leading efforts to ensure inclusive enrollment practices:a. DR. Portillo will be actively engaged in protocol development to ensure optimalstudy design to… $21,547
The Nemours Foundation The Nemours Foundation / Nemours Children’s Hospital, Delaware will support the pediatric acute-pain ketamine versus morphine trial. Dr. Amy Thompson will serve… $157,013
University Of Utah Bradley john barney will be a CO-investigator on the proposed application. He will be responsible for all aspects of the proposed DCC/pecarn EDC activities… $924,134
University Of Pittsburgh - Of The Commonwealth System Of Higher Education University of Pittsburgh / Children’s Hospital of Pittsburgh will support the pediatric acute-pain ketamine versus morphine trial. Dr. Maren Lunoe will serve as… $142,795
University Of California, Davis The Regents of the University of California, Davis will support “Efficacy of intravenous sub-dissociative ketamine versus intravenous morphine in children… $179,573
Marquette University Marquette University will support the pediatric acute-pain ketamine versus morphine trial through Dr. S. Iqbal Ahamed’s mHealth and technical expertise.… $64,710
Seattle Children's Hospital We will conduct an 8-site randomized clinical trial of 1010 children 6 to 17 year's old within thepediatric emergency care applied research network (pecarn),… $176,192
Children's Hospital LOS Angeles We will conduct an 8-site randomized clinical trial of 1010 children 6 to 17 years old within the Pediatric Emergency Care Applied Research Network (PECARN),… $168,366
Emory University We will conduct an 8-site randomized clinical trial of 1010 children 6 to 17 years old within the Pediatric Emergency Care Applied Research Network (PECARN),… $129,969
The Medical College Of Wisconsin, Inc. $222,415
Children's Hospital LOS Angeles Specific responsibilities include: • Assist in the development of study materials, including recruitment flyers and brochures • Introducing and providing… $88,102
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Quick answers

Who received award U01HD116253?

U01HD116253 was awarded to The Trustees Of Columbia University In The City Of New York by National Institute of Child Health and Human Development (National Institutes of Health) on September 5, 2024.

How much is award U01HD116253 worth?

$13,238,876 has been obligated on U01HD116253.

Which agency awarded U01HD116253?

National Institute of Child Health and Human Development (National Institutes of Health) awarded U01HD116253, with funding from National Institute of Neurological Disorders and Stroke (National Institutes of Health).

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