Pre-Hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg

Condition(s) targeted: Severe, Acute Pain in a Pre-Hospital Setting

Intervention: morphine (Drug); morphine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Toulouse

Official(s) and/or principal investigator(s):
Jean-Louis DUCASSE, Principal Investigator, Affiliation: University Hospital Toulouse, FRANCE

Overall contact:
Jean-Louis DUCASSE, MD, Phone: 0561772490, Ext: 33, Email: ducasse.jl@chu-toulouse.fr

Efficacy and safety of morphine titration on acute pain in emergency medical mobile units with initial bolus of 0. 1 mg/kg plus 0. 05 mg/kg versus morphine titration with initial bolus of 0. 05 mg/kg plus 0. 025 mg/kg

Official title: Pre-Hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration

Secondary outcome:

Time to obtain an analgesia, defined by a VRS < or = 30

Patients' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)

Investigators' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)

Safety evaluation

Detailed description: STUDY OBJECTIVE : Assess the efficacy of a morphine dose of 0. 1 mg/kg versus a morphine dose of 0. 05 mg/kg in pre-hospital pain METHODS : Consecutive patients with severe, acute pain defined as a verbal rating scale (VRS) of 60/100 or higher may be included. 106 patients at all are required in the study. They will be randomised in two groups : group A will receive an initial intravenous injection of 0. 05 mg/kg then injections of 0. 025 mg/kg every 5 minutes and group B will receive an initial intravenous injection 0. 1 mg/kg then injections of 0. 05 mg/kg every 5 minutes. The pain scale will be checked every 5 minutes during 30 minutes. The titration will be stopped before, if the VRS is < or = 30. The patient will be followed during the study until 60 minutes.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Severe, acute pain defined by a VRS of 60/100 or higher

- Male or female over 18 years

- Cared by a medical emergency care unit

- Written informed consent

- Affiliated to social security

Exclusion Criteria:

- A known opioid or paracetamol hypersensitivity

- Patient not agree ta participate at the study

- Pregnancy

- Uncontrolled epilepsia

- Incapacity to understand the VRS

- Renal, respiratory, or liver disease

- Patients who have received sedative drugs or alcohol (< 6h)

- Acute respiratory, haemodynamic or neurologic failure

- Patients who have already received an analgesic (< 6h)

- Drug addiction

- Patients under protection of justice

Jean-Louis DUCASSE, MD, Phone: 0561772490, Ext: 33, Email: ducasse.jl@chu-toulouse.fr

SAMU 31 Hôpital PURPAN, TOULOUSE 31059, France; Recruiting
Jean-Louis DUCASSE, MD
Jean-Louis DUCASSE, MD, Principal Investigator
Emmanuel VILLACEQUE, MD, Sub-Investigator
Patrick ROUX, MD, Sub-Investigator

Observatoire Régional Urgences Midi-Pyrénées, Rapport annuel sur l'activité des services d'urgence 2004

Related publications:

Ricard-Hibon A, Leroy N, Magne M, Leberre A, Chollet C, Marty J. [Evaluation of acute pain in prehospital medicine] Ann Fr Anesth Reanim. 1997;16(8):945-9. French.

Ricard-Hibon A, Marty J. Prise en charge de la douleur en milieu préhospitalier, In SFAR, Conférences d'actualisation 2001, Paris, Elsevier,2001;pp 709-22

Starting date: September 2005
Ending date: January 2006
Last updated: April 7, 2008