Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
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|ClinicalTrials.gov Identifier: NCT01951963|
Recruitment Status : Completed
First Posted : September 27, 2013
Results First Posted : October 16, 2017
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Ketamine Drug: Morphine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Sub-dissociative Ketamine for the Management of Acute Pediatric Pain|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Ketamine, single dose, 0.3 mg/kg, IV
Active Comparator: Morphine
Morphine, single dose, 0.05 mg/kg, IV
- Cumulative Narcotic Consumption [ Time Frame: 3 hours post study drug administration ]All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results.
- Adverse Drug Reaction [ Time Frame: 3 hours post study drug administration ]Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form.
- Pain Scale Rating Agreement Among Patient, Parent, and Research Staff [ Time Frame: Up to 3 hours post pain medication administration ]
FLACC scores were assessed on the patient using the FLACC scale (0-10) by the parent, treating RN/trained research assistant.
- FLACC - Parents 30 Minutes Post dose
- FLACC - Staff 30 Minutes Post dose
Wong-Baker Faces scale is a self-assessment of pain Scale of 1-10 pain.
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): NCT01951963
|United States, Minnesota|
|Saint Paul, Minnesota, United States, 55101|
|Principal Investigator:||Aaron M Burnett, MD||Regions Hospital|