Limb Injury Clinical Trial
— ANTAMINOfficial title:
Pain Reduction for Limb Injuries in Pediatric Emergency Departments: A Randomised Clinical Trial Comparing Intranasal Fentanyl or Intranasal Ketamine to Oral Morphine
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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | September 2027 |
Est. primary completion date | September 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility | Inclusion Criteria: - Child aged 2 years to 17 years and 11 months - With 10 kg = Weight = 100 kg - Presenting to ED with a traumatic pain and suspected fracture(s) based on an acute deformity AND experiencing pain and/or functional impotence in the injured limb(s) - Within the first 12 hours after the injury - VAS pain score at ED arrival = 60/100 (if child = 7 years) or Evendol pain score at ED arrival = 7/15 (if child < 7 years) - Affiliated to health insurance - At least one signed parental informed consent Exclusion Criteria: - Received narcotic pain medication prior to arrival - Contraindication to morphine, mentioned in SmPC - Hypersensitivity to ketamine or fentanyl or to excipients (sodium chloride, sodium hydroxide), or to other opioids. - Contraindication to fentanyl or ketamine, mentioned in SmPC - GCS <15 - Evidence of significant femur, head, chest, abdominal, or spine injury - Open fracture - Nasal trauma or complete nasal obstruction - Active epistaxis - Nasal or sinus surgery within 6 months before inclusion - History of high blood pressure, known coronary artery disease, congestive heart failure, acute glaucoma, increased intracranial pressure, major psychiatric disorder, hepatocellular insufficiency - Active or history of psychiatric disorder - Known pregnancy or suspicion of being pregnant - Breastfeeding - Non-French speaking parent and / or child. - Participation to another interventional clinical research |
Country | Name | City | State |
---|---|---|---|
France | Hopital Necker Enfants malades | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Reduction in pain (M15) | Reduction in pain from baseline assessed by Evendol for children <7 years | 15 minutes | |
Secondary | Reduction in pain (M15) | Reduction in pain from baseline assessed by VAS for children = 7 years | 15 minutes | |
Secondary | Reduction in pain (M30) | Reduction in pain from baseline assessed by Evendol for children <7 years | 30 minutes | |
Secondary | Reduction in pain (M30) | Reduction in pain from baseline assessed by VAS for children = 7 years | 30 minutes | |
Secondary | Reduction in pain (M60) | Reduction in pain from baseline assessed by Evendol for children <7 years | 60 minutes | |
Secondary | Reduction in pain (M60) | Reduction in pain from baseline assessed by VAS for children = 7 years | 60 minutes | |
Secondary | Reduction in pain (M90) | Reduction in pain from baseline (assessed by Evendol for children <7 years, by VAS for children = 7 years) | 90 minutes | |
Secondary | Reduction in pain (M90) | Reduction in pain from baseline assessed by Evendol for children <7 years | 90 minutes | |
Secondary | Reduction in pain (M120) | Reduction in pain from baseline by VAS for children = 7 years | 120 minutes | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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