Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine
NCT Number: NCT06464146
Acronym: ANTAMIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Limb Injury
Interventions: DRUG: Morphine|DRUG: IN fentanyl|DRUG: IN ketamine|DRUG: NaCl 0,9 %
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: CHILD
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-09
Locations: Hopital Necker Enfants malades, Paris, 75015, France

Summary:
The purpose of this study is to determine if IN fentanyl (1.5 µg/kg) or IN ketamine (1 mg/kg) is more effective at 30 minutes than oral morphine (0.5 mg/kg) in reduction of moderate and severe pain associated with limb injuries in patients 2-17 years of age presenting to the ED.

Primary Outcome Measures: Degree of pain (M30), Success: children \<7 years with a pain score assessed by Evendol \< 5 years, 30 minutes after drugs administration, without rescue analgesia. Scale: 0-15 (no pain - painful), 30 minutes|Degree of pain (M30), Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 30 minutes after drugs administration, without rescue analgesia. Visual Analog Scale : 0-100 (no pain- painful), 30 minutes
Secondary Outcome Measures: Degree of pain (M15), Success: children \<7 years with a pain score assessed by Evendol \< 5, 15 minutes after drugs administration, without rescue analgesia, 15 minutes|Degree of pain (M15), Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 15 minutes after drugs administration, without rescue analgesia, 15 minutes|Degree of pain (M60), Success: children \<7 years with a pain score assessed by Evendol \< 5, 60 minutes after drugs administration, without rescue analgesia, 60 minutes|Degree of pain (M60), Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 60 minutes after drugs administration, without rescue analgesia, 60 minutes|Degree of pain (M90), Success: children \<7 years with a pain score assessed by Evendol \< 5, 90 minutes after drugs administration, without rescue analgesia, 90 minutes|Degree of pain (M90), Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 90 minutes after drugs administration, without rescue analgesia, 90 minutes|Degree of pain (M120), Success: children \<7 years with a pain score assessed by Evendol \< 5, 120 minutes after drugs administration, without rescue analgesia, 120 minutes|Degree of pain (M120), Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 120 minutes after drugs administration, without rescue analgesia, 120 minutes|Reduction in pain (M15), Reduction in pain from baseline assessed by Evendol for children \<7 years, 15 minutes|Reduction in pain (M15), Reduction in pain from baseline assessed by VAS for children ≥ 7 years, 15 minutes|Reduction in pain (M30), Reduction in pain from baseline assessed by Evendol for children \<7 years, 30 minutes|Reduction in pain (M30), Reduction in pain from baseline assessed by VAS for children ≥ 7 years, 30 minutes|Reduction in pain (M60), Reduction in pain from baseline assessed by Evendol for children \<7 years, 60 minutes|Reduction in pain (M60), Reduction in pain from baseline assessed by VAS for children ≥ 7 years, 60 minutes|Reduction in pain (M90), Reduction in pain from baseline (assessed by Evendol for children \<7 years, by VAS for children ≥ 7 years), 90 minutes|Reduction in pain (M90), Reduction in pain from baseline assessed by Evendol for children \<7 years, 90 minutes|Reduction in pain (M120), Reduction in pain from baseline by VAS for children ≥ 7 years, 120 minutes|Degree of pain (M30) for comparison ketamine vs fentanyl, Success pain evaluation, as defined in primary outcome (for the comparison between ketamine and fentanyl), 30 minutes|Degree of pain (M30) for comparison ketamine vs fentanyl, Success pain evaluation, as defined in primary outcome (for the comparison between ketamine and fentanyl) assessed by Evendol for children \<7 years, 30 minutes|Degree of pain (M30) for comparison ketamine vs fentanyl, Success pain evaluation, as defined in primary outcome (for the comparison between ketamine and fentanyl) assessed by VAS for children ≥ 7 years, 30 minutes|Level of sedation (M5), Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable), 5 minutes|Level of sedation (M10), Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable), 10 minutes|Level of sedation (M15), Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable), 15 minutes|Level of sedation (M30), Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable), 30 minutes|Level of sedation (M60), Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable), 60 minutes|Level of sedation (M90), Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable), 90 minutes|Level of sedation (M120), Level of sedation as measured by the University of Michigan Sedation Scale Score (UMSS) after drugs administration, from 0 (patient awake) to 4 (patient unawakable), 120 minutes|Number of participants with Adverse events, 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)., From study treatment intake until ED discharge, up to 1 day|Score of satisfaction, 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, up to 1 day