Phase III Clinical Trial Studying Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children
Overview
- Phase
- Phase 3
- Intervention
- Ibuprofen
- Conditions
- Pain
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 304
- Locations
- 1
- Primary Endpoint
- Degree of pain measured by the EVENDOL score
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Ibuprofen+placebo of paracetamol
Patients will receive in addition to morphine (usual care) ibuprofen and placebo of paracetamol
Intervention: Ibuprofen
Ibuprofen+placebo of paracetamol
Patients will receive in addition to morphine (usual care) ibuprofen and placebo of paracetamol
Intervention: Placebo
Paracetamol + placebo of ibuprofen
Patients will receive in addition to morphine (usual care) paracetamol and placebo of ibuprofen
Intervention: Paracetamol
Paracetamol + placebo of ibuprofen
Patients will receive in addition to morphine (usual care) paracetamol and placebo of ibuprofen
Intervention: Placebo
Paracetamol + ibuprofen
Patients will receive in addition to morphine (usual care) paracetamol and ibuprofen
Intervention: paracetamol + ibuprofen
Placebo of paracetamol + placebo of ibuprofen
Patients will receive morphine alone(usual care).
Intervention: Placebo
Outcomes
Primary Outcomes
Degree of pain measured by the EVENDOL score
Time Frame: 30 minutes
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)
Degree of pain measured by the Visual Analog Scale
Time Frame: 30 minutes
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)
Secondary Outcomes
- Tolerance of morphine(120 minutes)
- Degree of pain measured by the EVENDOL score(120 minutes)
- Degree of pain measured by the Visual Analog Scale(120 minutes)
- Tolerance of ibuprofen(120 minutes)
- Tolerance of paracetamol(120 minutes)