Networks We Collaborate With
Collaborative Pediatric Critical Care Research Network
Brings single IRB functions for the NICHD-funded network into the Utah Data Coordinating Resource Center
Pediatric Emergency Care Applied Research Network
Brings single IRB functions for the NICHD-funded network into the Utah Data Coordinating Resource Center
Studies and Trials
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
KALPAS is a phase 3, randomized, double-blind, placebo-controlled trial that aims to investigate the effectiveness of ketamine in reducing chronic post-mastectomy pain. KALPAS is a multisite trial involving 16 participating sites across the United States. Approximately 750 adult women undergoing mastectomy or prophylactic mastectomy for oncologic reasons will be enrolled over the span of four years.
Participants will be randomized into one of three arms. The first arm will receive continuous ketamine infusion (0.35 mg/kg after induction, followed by 0.25 mg/kg/hr infusion) for up to a maximum of six hours during surgery, and continued for two hours after surgery. The second arm will receive a single dose (0.6 mg/kg) of ketamine in the post-anesthesia care unit plus two hours of saline administration after surgery. The control group will receive saline during surgery, in the post-anesthesia care unit, and continued for two hours after surgery. Data on postoperative pain and opioid use will be collected using medical record abstraction. Follow-up questionnaires assessing pain, mood, and function will be completed by participants after surgery at various time points over a 12-month period.
Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain
PRESENCE is a Phase 3, randomized, controlled trial aimed at determining the effectiveness of digital cognitive behavioral therapy (CBT) in reducing pain, opioid use, and healthcare utilization among adolescents and young adults (AYAs) with sickle cell disease (SCD). PRESENCE also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions.
This multisite trial involved 15 clinical sites across the United States, as well as online virtual sites. Approximately 470 AYAs with SCD, aged 16-30, will be enrolled into one of the three groups. The first group will receive a digital CBT program with weekly peer support via text or phone. The second group will receive self-guided digital CBT without peer support. The control group will continue with usual care. A mobile application will be used by participants to access the study intervention and perform Ecological Momentary Assessment (EMA) data collection. Enrollment is expected to begin in the fall of 2024.
A Sequenced-Strategy for Improving Outcomes in People with Knee Osteoarthritis Pain
This multisite, randomized controlled trial will enroll approximately 900 participants in Phase 1 and 900 participants in Phase 2 that have knee osteoarthritis and chronic pain. Phase 1 includes randomization to one of three minimally invasive treatments: best practices, duloxetine plus best practices, duloxetine plus best practices combined with painTRAINER (a web-based cognitive behavioral therapy). Phase 2 includes randomization into one of three more invasive treatments: Intra-articular injection of hyaluronic acid with steroid and bupivacaine, genicular nerve block with liposomal bupivacaine and sham radio frequency ablation with steroid injection, genicular nerve radio frequency ablation with steroid injection. Participants can be enrolled and treated for up to 2 years in phase 1 and 1 year in phase 2. Participants may enroll directly into phase 2 or progress to phase 2 following completion of phase 1 if additional treatment is requested. Primarily the study is looking and change in pain intensity at 8 weeks in phase 1 and 12 weeks in phase 2.
Tailored Non-Pharmacotherapy Services for Chronic Pain
The RESOLVE study is a multicenter comparative effectiveness trial evaluating two cognitive-behavioral therapy (CBT)-based chronic pain treatments delivered via different telehealth modalities: 1) online program (via PainTrainer) and 2) live, coach-led, virtual sessions (telephone and/or video conference). The study uses a 3-arm, parallel intervention design; Both intervention arms will be compared to usual care services. Participants randomized to the two intervention arms will complete 8 CBT-based sessions for chronic pain (approximately 1 per week) via the online PainTrainer program (self-directed) or one-on-one with the live coach. Those randomized to usual care will receive an education resource manual for chronic pain management. All study participants will be enrolled for 12 months and complete self-reported assessments at baseline, notification of randomization, and 3-, 6-, and 12-months.
Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery
The study team developed an mHealth pain-management intervention, the SurgeryPal app, to target psychosocial risk factors and teach pain-management skills for youth undergoing major spinal surgery. This study is a randomized, controlled trial to test effectiveness of the SurgeryPal intervention versus an education control. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4-week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4-week duration between weeks 2 and 6 following surgery). Thus there will be 4 treatment arms. Study participants will be enrolled for 6 months and complete self-reported assessments at baseline, post-surgery, 3-, and 6- months.
Integrated Treatment for Veterans with Co-Occurring Chronic Pain and Opioid Use Disorder
This multisite, randomized control trial will enroll 160 veterans who are currently being treated in VA-based clinics specializing in physician management of co-occurring chronic pain and opioid use disorder (OUD). The study will mainly examine the efficacy of 2 behavioral interventions (Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention [ACT+MBRP] and an Educational Control [EC]) in reducing pain interference and substance misuse in veterans with co-occurring chronic pain and opioid use disorder that are prescribed Buprenorphine.
Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children
This is a multicenter double-blind randomized controlled trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically ventilated critically ill children. This trial will evaluate the opioid-sparing effect of dexmedetomidine when administered with fentanyl to mechanically ventilated critically ill children. Study drug or placebo will be administered with fentanyl, which will be titrated to achieve sedation scores consistent with response to light touch. Plasma samples and bedside assessments for pain, sedation, and delirium will be collected.