Pain Clinical Trial
— PRIMEOfficial 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
Verified date | October 2018 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 21, 2017 |
Est. primary completion date | February 22, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference From Baseline in Visual Analog Scale Pain Score | 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. | 30 minutes after study medication | |
Secondary | Difference From Baseline in Visual Analog Scale Pain Score | 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. | 15 minutes after study medication | |
Secondary | Difference From Baseline in Visual Analog Scale Pain Score | 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. | 60 minutes after study medication | |
Secondary | Highest Achieved University of Michigan Sedation Scale (UMSS) Score | 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) | 15, 30, and 60 minutes after study medication administration | |
Secondary | Rescue Analgesia | Documentation of additional pain medication after study medication administration | Within the first 60 minutes after study medication | |
Secondary | Heart Rate | 15 minutes after study medication | ||
Secondary | Heart Rate | 30 minutes after study medication | ||
Secondary | Heart Rate | 60 minutes after study medication | ||
Secondary | Respiratory Rate | 15 minutes after study medication | ||
Secondary | Respiratory Rate | 30 minutes after study medication | ||
Secondary | Respiratory Rate | 60 minutes after study medication | ||
Secondary | Systolic Blood Pressure | 15 minutes after study medication | ||
Secondary | Systolic Blood Pressure | 30 minutes after study medication | ||
Secondary | Systolic Blood Pressure | 60 minutes after study medication | ||
Secondary | Diastolic Blood Pressure | 15 minutes after study medication | ||
Secondary | Diastolic Blood Pressure | 30 minutes after study medication | ||
Secondary | Diastolic Blood Pressure | 60 minutes after study medication | ||
Secondary | Oxygen Saturation | 15 minutes after study medication | ||
Secondary | Oxygen Saturation | 30 minutes after study medication | ||
Secondary | Oxygen Saturation | 60 minutes after study medication | ||
Secondary | Capnometry Value | 15 minutes after study medication | ||
Secondary | Capnometry Value | 30 minutes after study medication | ||
Secondary | Capnometry Value | 60 minutes after study medication |
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