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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
oral morphine (0.5 mg / kg)
IN fentanyl (1.5 µg/kg)
IN ketamine (1 mg/kg)
Ambroise Paré Hospital
Boulogne-Billancourt, France
RECRUITINGRoger Salengro Hospital
Lille, France
RECRUITINGTimone Hospital
Marseille, France
RECRUITINGDegree 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)
Time frame: 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)
Time frame: 30 minutes
Degree of pain (M15)
Success: children \<7 years with a pain score assessed by Evendol \< 5, 15 minutes after drugs administration, without rescue analgesia
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Injectable solution used as Placebo of Oral morphine or IN fentanyl/ ketamine.
Mère-Enfant Hospital
Nantes, France
RECRUITINGHopital Necker Enfants malades
Paris, France
RECRUITINGTime frame: 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
Time frame: 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
Time frame: 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
Time frame: 120 minutes
Reduction in pain (M15)
Reduction in pain from baseline assessed by Evendol for children \<7 years
Time frame: 15 minutes
Reduction in pain (M15)
Reduction in pain from baseline assessed by VAS for children ≥ 7 years
Time frame: 15 minutes
Reduction in pain (M30)
Reduction in pain from baseline assessed by Evendol for children \<7 years
Time frame: 30 minutes
Reduction in pain (M30)
Reduction in pain from baseline assessed by VAS for children ≥ 7 years
Time frame: 30 minutes
Reduction in pain (M60)
Reduction in pain from baseline assessed by Evendol for children \<7 years
Time frame: 60 minutes
Reduction in pain (M60)
Reduction in pain from baseline assessed by VAS for children ≥ 7 years
Time frame: 60 minutes
Reduction in pain (M90)
Reduction in pain from baseline (assessed by VAS for children ≥ 7 years)
Time frame: 90 minutes
Reduction in pain (M90)
Reduction in pain from baseline assessed by Evendol for children \<7 years
Time frame: 90 minutes
Reduction in pain (M120)
Reduction in pain from baseline assessed by VAS for children ≥ 7 years
Time frame: 120 minutes
Reduction in pain (M120)
Reduction in pain from baseline assessed by EVENDOL for children \< 7 years
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: At ED discharge, up to 1 day