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

NCT ID: NCT00237731

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-03-31

Brief Summary

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

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.

Conditions

Severe, Acute Pain in a Pre-hospital Setting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

morphine 0.05

Group Type: EXPERIMENTAL

morphine

Intervention Type: DRUG

morphine 0.05

2

morphine 0.10

Group Type: ACTIVE_COMPARATOR

morphine

Intervention Type: DRUG

morphine 0.10

Interventions

morphine

morphine 0.05

Intervention Type: DRUG

morphine

morphine 0.10

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

UHToulouse

Principal Investigators

Jean-Louis DUCASSE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse, France

Locations

SAMU 31 Hôpital PURPAN

Toulouse, , France

Countries

France

References

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. doi: 10.1016/s0750-7658(97)82142-9. French.

Reference Type: BACKGROUND

PMID: 9750642 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Bounes V, Charpentier S, Houze-Cerfon CH, Bellard C, Ducasse JL. Is there an ideal morphine dose for prehospital treatment of severe acute pain? A randomized, double-blind comparison of 2 doses. Am J Emerg Med. 2008 Feb;26(2):148-54. doi: 10.1016/j.ajem.2007.04.020.

Reference Type: RESULT

PMID: 18272093 (View on PubMed)

Related Links

http://www.orumip.fr

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

Other Identifiers

0505103

Identifier Type: -

Identifier Source: org_study_id