CompletedPhase 3

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

France304 participantsStarted 2015-12-03

Plain-language 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.

Who can participate

Age range2 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Degree of pain measured by the EVENDOL score

Timeframe: 30 minutes

Degree of pain measured by the Visual Analog Scale

Timeframe: 30 minutes

Trial details

NCT IDNCT02477007

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-21

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