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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06464146
Other study ID # APHP211044
Secondary ID 2023-506803-25
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date September 2024
Est. completion date September 2027

Study information

Verified date June 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Hélène CHAPPUY, MD, PhD
Phone +33 1 44 49 41 26
Email helene.chappuy@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Morphine
oral morphine (0.5 mg / kg)
IN fentanyl
IN fentanyl (1.5 µg/kg)
IN ketamine
IN ketamine (1 mg/kg)
NaCl 0,9 %
Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine.

Locations

Country Name City State
France Hopital Necker Enfants malades Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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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