A VAS score is a self reported pain score of 0-100 millimeters (0 = no pain; 100 = worst possible pain). A decrease in a VAS score indicates a decrease in pain severity.
Pain Reduction With Intranasal Medications for Extremity Injuries
Brief Summary
This study compares the analgesic effect of intranasal sub-dissociative dosing of ketamine and intranasal fentanyl in children presenting to the Emergency Department with acute extremity injuries.
Condition or Disease
- Pain
- Traumatic Limb Injury
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 8 Years to 17 Years |
| Enrollment: | 90 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | Mar 31, 2016 | ACTUAL |
|---|---|---|
| Primary Completion: | Feb 22, 2017 | ACTUAL |
| Completion Date: | Mar 21, 2017 | ACTUAL |
| Study First Posted: | May 20, 2016 | ESTIMATED |
| Results First Posted: | Sep 01, 2020 | ACTUAL |
| Last Updated: | Aug 18, 2020 |
Sponsors / Collaborators
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Lead sponsor is responsible party
Responsible Party:
N/A
Location
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.
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.
Participant Groups
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Ketamine 1.5 mg/kg intranasally for one dose
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Fentanyl 2 mcg/kg intranasally for one dose
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 8 |
| Maximum Age: | 17 |
| Age Groups: | Child |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* 8 years to 17 years (up to the 18th birthday)
* Presenting to emergency department with one or more extremity injuries
* Visual analog scale score 35 mm or greater
* Parent or legal guardian present and willing to provide written consent
Exclusion Criteria:
* Received narcotic pain medication prior to arrival
* Evidence of significant head, chest, abdomen, or spine injury
* Glasgow coma score less than 15 or unable to self report pain score
* Nasal trauma or aberrant nasal/airway anatomy
* Active epistaxis
* Allergy to ketamine, fentanyl or meperidine
* Non-English speaking parent and/or child
* History of psychosis
* Postmenarchal female without a urine or serum assay documenting the absence of pregnancy
* Brought in my juvenile detention center or in police custody
* Pregnancy
* 8 years to 17 years (up to the 18th birthday)
* Presenting to emergency department with one or more extremity injuries
* Visual analog scale score 35 mm or greater
* Parent or legal guardian present and willing to provide written consent
Exclusion Criteria:
* Received narcotic pain medication prior to arrival
* Evidence of significant head, chest, abdomen, or spine injury
* Glasgow coma score less than 15 or unable to self report pain score
* Nasal trauma or aberrant nasal/airway anatomy
* Active epistaxis
* Allergy to ketamine, fentanyl or meperidine
* Non-English speaking parent and/or child
* History of psychosis
* Postmenarchal female without a urine or serum assay documenting the absence of pregnancy
* Brought in my juvenile detention center or in police custody
* Pregnancy
Primary Outcomes
Secondary Outcomes
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A VAS score is a self reported pain score of 0-100 millimeters (0 = no pain; 100 = worst possible pain). A decrease in a VAS score indicates a decrease in pain severity.
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A VAS score is a self reported pain score of 0-100 millimeters (0 = no pain; 100 = worst possible pain). A decrease in a VAS score indicates a decrease in pain severity.
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The University of Michigan Sedation Scale is a valid and reliable tool that allows for rapid assessment of the depth of sedation in children. It is a simple observational tool that assesses the level of alertness on a five-point scale. It has been validated in children and has shown to have significant inter-rater reliability. Score is 0-4 (0 = awake and alert; 1= minimally sedated; 2 = moderately sedated; 3 = deeply sedated; 4 = unarousable)
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Documentation of additional pain medication after study medication administration
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Heart Rate 15 minutes after study medication
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Heart Rate 30 minutes after study medication
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Heart Rate 60 minutes after study medication
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Respiratory Rate 15 minutes after study medication
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Respiratory Rate 30 minutes after study medication
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Respiratory Rate 60 minutes after study medication
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Systolic Blood Pressure 15 minutes after study medication
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Systolic Blood Pressure 30 minutes after study medication
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Systolic Blood Pressure 60 minutes after study medication
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Diastolic Blood Pressure 15 minutes after study medication
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Diastolic Blood Pressure 30 minutes after study medication
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Diastolic Blood Pressure 60 minutes after study medication
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Oxygen Saturation 15 minutes after study medication
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Oxygen Saturation 30 minutes after study medication
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Oxygen Saturation 60 minutes after study medication
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Capnometry Value 15 minutes after study medication
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Capnometry Value 30 minutes after study medication
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Capnometry Value 60 minutes after study medication
More Details
| NCT Number: | NCT02778880 |
|---|---|
| Acronym: | PRIME |
| Other IDs: | CIN_PRIME_001 |
| Study URL: | https://clinicaltrials.gov/study/NCT02778880 |
Last updated: Sep 29, 2023