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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506803-25 | EudraCT Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
In children with moderate to severe pain due to musculoskeletal injuries, the first-line analgesic therapy in pediatric emergency departments (ED) is oral or intravenous morphine. Due to the delay or discomfort associated with establishing IV access, oral forms are preferred in French ED. Unfortunately, oral morphine alone or with ibuprofen or paracetamol, none regimen is optimal for relieving pain in children with traumatic limb injuries. However, the use of intranasal course is a safe route that can provide rapid and almost immediate analgesia. Intranasal administration is easy, non-invasive and usually well tolerated by children. In the last years, drugs with analgesic and sedative properties is increasing, particularly on fentanyl, ketamine, which can be also administered by the IN route. There are currently no studies, neither published nor ongoing, which compare IN fentanyl or IN ketamine to a standard oral morphine for children with acute moderate to severe pain with limb injuries presenting to the ED. The main hypothesis is that the efficacy of the analgesia 30 minutes after the administration will be higher with IN Fentanyl or with IN Ketamine, when compared to oral morphine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine | Active Comparator | Oral morphine (0.5mg/kg) and IN placebo |
|
| IN Fentanyl | Experimental | placebo of oral morphine and IN fentanyl (1.5 µg/kg) |
|
| IN Ketamin | Experimental | placebo of oral morphine and IN ketamine (1 mg/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | oral morphine (0.5 mg / kg) |
| |
| IN fentanyl |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hélène CHAPPUY, MD, PhD | Contact | +33 1 44 49 41 26 | helene.chappuy@aphp.fr | |
| Nelly BRIAND, PhD | Contact | 0144381862 | nelly.briand@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Hélène CHAPPUY, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambroise Paré Hospital | Recruiting | Boulogne-Billancourt | 92100 | France |
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| Drug |
IN fentanyl (1.5 µg/kg) |
|
| IN ketamine | Drug | IN ketamine (1 mg/kg) |
|
| NaCl 0,9 % | Drug | Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine. |
|
| 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 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 assessed by VAS for children ≥ 7 years | 120 minutes |
| Reduction in pain (M120) | Reduction in pain from baseline assessed by EVENDOL 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) 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 |
| Roger Salengro Hospital | Recruiting | Lille | 59000 | France |
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| Timone Hospital | Recruiting | Marseille | 13005 | France |
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| Mère-Enfant Hospital | Recruiting | Nantes | 44000 | France |
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| Hopital Necker Enfants malades | Recruiting | Paris | 75015 | France |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D005283 | Fentanyl |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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