Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children
Condition: Pain; Long-bone Fractures
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Paracetamol; Ibuprofen; paracetamol + ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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).; 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.
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Paediatric emergency; pain; long-bones fractures; morphine; ibuprofen; paracetamol; children