Phase 3
N=90
Pain Reduction With Intranasal Medications for Extremity Injuries
Pain · Traumatic Limb Injury
Bottom Line
View on ClinicalTrials.gov: NCT02778880 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Difference From Baseline in Visual Analog Scale Pain Score — -30.6; -31.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ketamine (Drug); Fentanyl (Drug)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference From Baseline in Visual Analog Scale Pain Score |
-27.7; -29.0 | — |
| SECONDARY Difference From Baseline in Visual Analog Scale Pain Score |
-27.7; -29.0 | — |
| SECONDARY Difference From Baseline in Visual Analog Scale Pain Score |
-27.7; -29.0 | — |
| SECONDARY Highest Achieved University of Michigan Sedation Scale (UMSS) Score |
23; 32; 17; 9; 4; 1 | — |
| SECONDARY Rescue Analgesia |
1; 3; 1; 3; 7; 3 | — |
| SECONDARY Heart Rate |
85.1; 82.9 | — |
| SECONDARY Heart Rate |
85.1; 82.9 | — |
| SECONDARY Heart Rate |
85.1; 82.9 | — |
| SECONDARY Respiratory Rate |
21.8; 19.7 | — |
| SECONDARY Respiratory Rate |
21.8; 19.7 | — |
| SECONDARY Respiratory Rate |
21.8; 19.7 | — |
| SECONDARY Systolic Blood Pressure |
122.3; 122.0 | — |
| SECONDARY Systolic Blood Pressure |
122.3; 122.0 | — |
| SECONDARY Systolic Blood Pressure |
122.3; 122.0 | — |
| SECONDARY Diastolic Blood Pressure |
70.8; 70.6 | — |
| SECONDARY Diastolic Blood Pressure |
70.8; 70.6 | — |
| SECONDARY Diastolic Blood Pressure |
70.8; 70.6 | — |
| SECONDARY Oxygen Saturation |
99.3; 99.3 | — |
| SECONDARY Oxygen Saturation |
99.3; 99.3 | — |
| SECONDARY Oxygen Saturation |
99.3; 99.3 | — |
| SECONDARY Capnometry Value |
38.7; 38.9 | — |
| SECONDARY Capnometry Value |
38.7; 38.9 | — |
| SECONDARY Capnometry Value |
38.7; 38.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02778880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.