limb injuries, urgency
Conditions
Brief summary
Success: children <7 years with a pain score assessed by Evendol < 5 or children ≥ 7 years with pain score assessed by VAS ≤ 30, 30 minutes after drugs administration, without rescue analgesia -Failure: Evendol ≥ 5 or VAS > 30, 30 minutes after drugs administration or need for rescue analgesia during the first 30 minutes after drugs administration
Detailed description
Success pain evaluation (success as defined in primary outcome) during the first 2 hours after drugs administration, at 15 (M15), 60 (M60), 90 (M90) and 120 minutes (M120), Reduction in pain scores from baseline at M15, M30, M60, M90 and M120, Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) at 5, 10, 15, 30, 60, 90 and 120 minutes after drugs administration., - Adverse events potentially associated with IN ketamine, IN fentanyl and/or oral morphine: drowsiness, dizziness, pruritus, nausea, vomiting, dysphoria, nasal burning and irritation, unpleasant taste, vision changes, throat irritation, headache, vital sign changes (heart rate, respiratory rate, oxygen saturation, blood pressure)., General satisfaction of parents and patient ≥ 7 years old on a scale of 0–100 with corresponding faces (0 = no satisfaction at all, 100 = very satisfied) at ED discharge
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success: children <7 years with a pain score assessed by Evendol < 5 or children ≥ 7 years with pain score assessed by VAS ≤ 30, 30 minutes after drugs administration, without rescue analgesia -Failure: Evendol ≥ 5 or VAS > 30, 30 minutes after drugs administration or need for rescue analgesia during the first 30 minutes after drugs administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Success pain evaluation (success as defined in primary outcome) during the first 2 hours after drugs administration, at 15 (M15), 60 (M60), 90 (M90) and 120 minutes (M120), Reduction in pain scores from baseline at M15, M30, M60, M90 and M120, Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) at 5, 10, 15, 30, 60, 90 and 120 minutes after drugs administration., - Adverse events potentially associated with IN ketamine, IN fentanyl and/or oral morphine: drowsiness, dizziness, pruritus, nausea, vomiting, dysphoria, nasal burning and irritation, unpleasant taste, vision changes, throat irritation, headache, vital sign changes (heart rate, respiratory rate, oxygen saturation, blood pressure)., General satisfaction of parents and patient ≥ 7 years old on a scale of 0–100 with corresponding faces (0 = no satisfaction at all, 100 = very satisfied) at ED discharge | — |
Countries
France