Pain Reduction With Intranasal Medications for Extremity Injuries (PRIME)
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|ClinicalTrials.gov Identifier: NCT02778880|
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain Traumatic Limb Injury||Drug: Ketamine Drug: Fentanyl||Phase 3|
Inadequate pain control, especially in the emergency department (ED), is a major public health concern. Despite increased awareness, pain continues to be underdiagnosed and undertreated, particularly in the pediatric population. Children often encounter long delays in medication administration, possibly due to the time required to obtain intravenous access. The intranasal administration route offers a more efficient alternative for faster and noninvasive delivery of pain medication. This route is gaining popularity secondary to its rapid onset of active, minimal discomfort and relative simplicity.
Opioids are the most commonly used class of analgesic pain medication for children presenting in severe pain due to traumatic injuries. Despite their potential effectiveness, opioids have several concerning adverse effects, particularly when administered prior to procedural sedation in children. Administration of pre-procedural sedation opioids is associated with an increased risk of serious adverse events (oxygen desaturation, apnea, and hypotension) as well as the need for significant interventions, such as bag-mask ventilation, intubation, and pharmacologic blood pressure support. In addition, due to genetic variations that may lead to increased or diminished opioid sensitivity, ideal dosing to adequately control severe pain yet avoid adverse medication-related side effects is difficult to ascertain. Many children in severe pain do not receive opioids, receive doses that are below those recommended or experience long delays in receiving opioids. The reasons for this are unclear, but the investigators speculate that this may be due in part to fear of adverse effects of opioids, provider inexperience with opioid use in children or fear of contributing to opioid tolerance or abuse. For all of these reasons, providers often seek non-opioid alternatives for pediatric patients with acute, severe pain.
Ketamine, in sub-dissociative doses administered by the intravenous or intranasal route, is emerging as an alternative medication for the treatment of moderate to severe pain in multiple settings. In adults, low dose ketamine is well tolerated and has been used successfully as an adjuvant and an alternative to opioids to provide rapid pain relief in the ED. As a dissociative anesthetic, ketamine is the most commonly used agent to facilitate painful procedures in the pediatric emergency department. At lower doses, it has been used in children to provide analgesia in a variety of acute and chronic pain settings, including terminal diagnoses, sickle cell disease, perioperative pain, traumatic injuries, extensive burns and conditions where opioids are contraindicated. Similar to adults, ketamine has been used via the intranasal route to provide adequate analgesia and sedation in children in the pre-hospital setting and in those undergoing procedures.
The objective of this study is to compare intranasal sub-dissociative ketamine with intranasal fentanyl for treatment of acute pain associated with traumatic limb injuries in children presenting to the ED and to document an objective respiratory side effect profile utilizing noninvasive capnometry. If found to be an effective analgesic, intranasal ketamine would be particularly useful in children who experience adverse effects with opioids, have developed opioid tolerance as a result of chronic painful conditions, have poor opioid sensitivity due to their genetic predisposition or in pediatric trauma patients with the potential for hypotension. Additionally, for patients that require procedural sedation for fracture reduction, avoiding opioids early in the emergency department visit may decrease sedation recovery time and the risk of serious adverse events during sedation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of Intranasal Sub-dissociative Dosing of Ketamine Compared to Intranasal Fentanyl for Treatment of Pain Associated With Acute Extremity Injuries in Children|
|Actual Study Start Date :||March 31, 2016|
|Actual Primary Completion Date :||February 22, 2017|
|Actual Study Completion Date :||March 21, 2017|
Ketamine 1.5 mg/kg intranasally for one dose
Other Name: Ketalar
Active Comparator: Fentanyl
Fentanyl 2 mcg/kg intranasally for one dose
- Visual Analog Scale Pain Score [ Time Frame: 30 minutes ]Self reported pain score 30 minutes after study medication administration. Score is 0-100 mm (0 = no pain; 100 = worst pain imaginable)
- University of Michigan Sedation Scale Score [ Time Frame: 15, 30 and 60 minutes ]Clinician reported sedation score 15, 30 and 60 minutes after study medication administration. Score is 0-4 (0 = awake and alert; 4 = unarousable)
- Adverse Events [ Time Frame: 15, 30 and 60 minutes ]Self and clinician reported adverse events 15, 30 and 60 minutes after study medication administration
- Additional opioid pain medication administration after study medication [ Time Frame: 15, 30 and 60 minutes ]Documentation of additional pain medication at 15, 30 and 60 minutes after study medication administration
- Visual Analog Scale Pain Score [ Time Frame: 15 and 60 minutes ]Self reported pain score 15 and 60 minutes after study medication administration. Score is 0-100 mm (0 = no pain; 100 = worst pain imaginable)
- Heart rate [ Time Frame: 15, 30 and 60 minutes ]Clinician obtained heart rate 15, 30 and 60 minutes after study medication administration.
- Respiratory rate [ Time Frame: 15, 30 and 60 minutes ]Clinician obtained respiratory rate 15, 30 and 60 minutes after study medication administration.
- Blood pressure [ Time Frame: 15, 30 and 60 minutes ]Clinician obtained blood pressure 15, 30 and 60 minutes after study medication administration.
- Oxygen saturation [ Time Frame: 15, 30 and 60 minutes ]Clinician obtained oxygen saturation 15, 30 and 60 minutes after study medication administration.
- Capnometry value [ Time Frame: 15, 30 and 60 minutes ]Clinician obtained capnometry value 15, 30 and 60 minutes after study medication administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778880
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Theresa M Frey, MD||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Matthew R Mittiga, MD||Children's Hospital Medical Center, Cincinnati|