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

Information source: University Hospital, Toulouse
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Intervention: morphine (Drug); morphine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital, Toulouse

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


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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.


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

Locations and Contacts

SAMU 31 Hôpital PURPAN, Toulouse 31059, France
Additional Information

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

SFAR. Quelles sont les modalités de réalisation d'une sédation et/ou d'une analgésie du malade en ventilation spontanée. In : SFAR eds. Modalités de la sédation et/ou de l'analgésie en situation extrahospitalière : Conférence d'experts. Paris, Elsevier;2000;pp 37-51

SFUM. Troisième conférence de consensus en médecine d'urgence de la Société francophone d'urgence médicale. Le traitement médicamenteux de la douleur de l'adulte dans un service d'accueil et d'urgence. Réan Urg 1993; 2:321-7

Starting date: September 2005
Last updated: February 25, 2010

Page last updated: August 23, 2015

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