Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children (MORPHAPAIN)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Long-bone Fractures; Pain

Treatments: Drug: Ibuprofen; Drug: Paracetamol; Drug: Placebo; Drug: paracetamol + ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02477007

2015-001458-14 (EudraCT Number)

P130921

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children aged 2 through 17 years (17 years included)
• suspected fracture of a long bone requiring morphine analgesia (VAS ≥ 60/100 or Evendol ≥ 7/15 at the arrival at emergency department)
• within the first 12 hours after the injury
• at least one signed parental informed consent
• affiliated to health insurance

Exclusion criteria

• analgesic treatment within the 6 hours before inclusion
• contraindication to one of the experimental drug: Paracetamol or Ibuprofen
• contraindication to Morphine
• cognitive impairment
• multiple injuries
• resuscitation manœuvres
• suspected femur fracture
• open fracture
• pregnant women in the third trimester

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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304 participants in 4 patient groups, including a placebo group

Ibuprofen+placebo of paracetamol

Experimental group

Description:

Patients will receive in addition to morphine (usual care) ibuprofen and placebo of paracetamol

Treatment:

Drug: Placebo

Drug: Ibuprofen

Paracetamol + placebo of ibuprofen

Experimental group

Description:

Patients will receive in addition to morphine (usual care) paracetamol and placebo of ibuprofen

Treatment:

Drug: Placebo

Drug: Paracetamol

Paracetamol + ibuprofen

Experimental group

Description:

Patients will receive in addition to morphine (usual care) paracetamol and ibuprofen

Treatment:

Drug: paracetamol + ibuprofen

Placebo of paracetamol + placebo of ibuprofen

Placebo Comparator group

Description:

Patients will receive morphine alone(usual care).

Treatment:

Drug: Placebo