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

NCT02477007 | Completed Phase 3

• 2 other identifiers: P1309212015-001458-14
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Long-bone Fractures

Keywords

Paediatric emergency; pain; long-bones fractures; morphine; ibuprofen; paracetamol; children

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  30 minutes

Secondary Outcomes (35)

• Degree of pain measured by the EVENDOL score

  after immobilisation

• Degree of pain measured by the EVENDOL score

  15 minutes

• Degree of pain measured by the EVENDOL score

  60 minutes

• Degree of pain measured by the EVENDOL score

  90 minutes

• Degree of pain measured by the EVENDOL score

  120 minutes

Study Arms (4)

Ibuprofen+placebo of paracetamol

EXPERIMENTAL

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

Drug: Ibuprofen; Drug: Placebo

Paracetamol + placebo of ibuprofen

EXPERIMENTAL

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

Drug: Paracetamol; Drug: Placebo

Paracetamol + ibuprofen

EXPERIMENTAL

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

Drug: paracetamol + ibuprofen

Placebo of paracetamol + placebo of ibuprofen

PLACEBO COMPARATOR

Patients will receive morphine alone(usual care).

Drug: Placebo

Interventions

Paracetamol DRUG

Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g).

Paracetamol + placebo of ibuprofen

Ibuprofen DRUG

Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg).

Ibuprofen+placebo of paracetamol

paracetamol + ibuprofen DRUG

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 + ibuprofen

Placebo DRUG

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.

Ibuprofen+placebo of paracetamol; Paracetamol + placebo of ibuprofen; Placebo of paracetamol + placebo of ibuprofen

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Paediatric emergency Armand Trousseau hospital

Paris, 75012, France

Location

Related Publications (3)

• Clark E, Plint AC, Correll R, Gaboury I, Passi B. A randomized, controlled trial of acetaminophen, ibuprofen, and codeine for acute pain relief in children with musculoskeletal trauma. Pediatrics. 2007 Mar;119(3):460-7. doi: 10.1542/peds.2006-1347.

  PMID: 17332198 BACKGROUND

• Koller DM, Myers AB, Lorenz D, Godambe SA. Effectiveness of oxycodone, ibuprofen, or the combination in the initial management of orthopedic injury-related pain in children. Pediatr Emerg Care. 2007 Sep;23(9):627-33. doi: 10.1097/PEC.0b013e31814a6a39.

  PMID: 17876251 BACKGROUND

• Morton NS, O'Brien K. Analgesic efficacy of paracetamol and diclofenac in children receiving PCA morphine. Br J Anaesth. 1999 May;82(5):715-7. doi: 10.1093/bja/82.5.715.

  PMID: 10536549 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Hélène Chappuy, MD PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: June 22, 2015
• Study Start: December 3, 2015
• Primary Completion: November 21, 2018
• Study Completion: November 21, 2018
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)