The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.
Long-bone fractures are a very common complain for visits in paediatric emergency departments. Since these fractures are often very painful, morphine is considered the cornerstone treatment in case of severe pain. Very few data are available concerning the assessment of analgesic treatment in this condition. In our previous study, less than 50% of patients with a limb fracture had a Visual Analog Scale (VAS) ≤ 30 mm after morphine administration. Thus, one study make the hypothesis that the use of a combination of morphine and/or paracetamol and/or NSAID could be an effective and safe option for the treatment of pain due to long bone fractures. We undertake to compare different combinations of paracetamol and ibuprofen with morphine to determine the efficacy and safety of these strategies in emergency department paediatric patients with acute traumatic limb pain. The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen. Second objectives are * to compare the long term analgesic efficacy of 4 analgesic regimens a)ibuprofen/morphine, b)paracetamol/morphine, c)ibuprofen/paracetamol/morphine and d)morphine for long bone fracture management in the paediatric emergency department. * To assess the tolerance of these 4 regimens. The study is considered as a success if children 2-6 years (6 years included) have a pain score Evendol \< 5 and children 7-17 years (17 years included) have a pain score assessed by Visual Analog Scale (VAS) ≤ 30 without additional analgesic treatment 30 minutes after drug administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
304
Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g).
Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg).
Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g) Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg).
Paediatric emergency Armand Trousseau hospital
Paris, France
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old. Success: children 2-6 years (6 years included) with a pain score Evendol \< 5 without additional analgesic treatment at 30 minutes after drug administration (DA)
Time frame: 30 minutes
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children. Success: children 7-17 years with pain score assessed by Visual Analog Scale (VAS) ≤ 30, without additional analgesic treatment at 30 minutes after drug administration (DA)
Time frame: 30 minutes
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old.
Time frame: after immobilisation
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old.
Time frame: 15 minutes
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old.
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Placebo will have the closest flavour, smell and aspect to the active substances, respectively paracetamol and ibuprofen. Placebo will be prepared in bottles with a fake label of active substances for a better blinding both for the nurse and the patient. Labels will be hiding by a mask.
Time frame: 60 minutes
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old.
Time frame: 90 minutes
Degree of pain measured by the EVENDOL score
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old.
Time frame: 120 minutes
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children.
Time frame: after immobilisation
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children.
Time frame: 15 minutes
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children.
Time frame: 60 minutes
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children.
Time frame: 90 minutes
Degree of pain measured by the Visual Analog Scale
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children.
Time frame: 120 minutes
Tolerance of ibuprofen
occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.
Time frame: 15 minutes
Tolerance of ibuprofen
occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.
Time frame: 30 minutes
Tolerance of ibuprofen
occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.
Time frame: 60 minutes
Tolerance of ibuprofen
occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.
Time frame: 90 minutes
Tolerance of ibuprofen
occurrence of abdominal pain or diarrhea or nausea or vomiting or digestive bleeding or itching or rash.
Time frame: 120 minutes
Tolerance of paracetamol
Occurrence of rash or hives or itching or swelling
Time frame: 15 minutes
Tolerance of paracetamol
Occurrence of rash or hives or itching or swelling
Time frame: 30 minutes
Tolerance of paracetamol
Occurrence of rash or hives or itching or swelling
Time frame: 60 minutes
Tolerance of paracetamol
Occurrence of rash or hives or itching or swelling
Time frame: 90 minutes
Tolerance of paracetamol
Occurrence of rash or hives or itching or swelling
Time frame: 120 minutes
Tolerance of morphine
heart and respiratory rates,
Time frame: 15 minutes
Tolerance of morphine
heart and respiratory rates,
Time frame: 30 minutes
Tolerance of morphine
heart and respiratory rates,
Time frame: 60 minutes
Tolerance of morphine
heart and respiratory rates,
Time frame: 90 minutes
Tolerance of morphine
heart and respiratory rates,
Time frame: 120 minutes
Tolerance of morphine
oxygen saturation
Time frame: 15 minutes
Tolerance of morphine
oxygen saturation
Time frame: 30 minutes
Tolerance of morphine
oxygen saturation
Time frame: 60 minutes
Tolerance of morphine
oxygen saturation
Time frame: 90 minutes
Tolerance of morphine
oxygen saturation
Time frame: 120 minutes
Tolerance of morphine
occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness
Time frame: 15 minutes
Tolerance of morphine
occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness
Time frame: 30 minutes
Tolerance of morphine
occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness
Time frame: 60 minutes
Tolerance of morphine
occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness
Time frame: 90 minutes
Tolerance of morphine
occurrence of consciousness nausea and vomiting or pruritus or drowsiness or dizziness
Time frame: 120 minutes