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

Severe, Acute Pain in a Pre-hospital Setting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237731
• Other study ID #: 0505103
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2005
• Last updated: May 10, 2017
• Start date: September 2005
• Est. completion date: March 2006

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Severe, Acute Pain in a Pre-hospital Setting

Intervention

Drug:
• morphine
morphine 0.05
• morphine
morphine 0.10

Locations

Country	Name	City	State
France	SAMU 31 Hôpital PURPAN	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (5)

Bounes V, Charpentier S, Houze-Cerfon CH, Bellard C, Ducassé 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.2 — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration
Secondary	Time to obtain an analgesia, defined by a VRS < or = 30
Secondary	Patients' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
Secondary	Investigators' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
Secondary	Safety evaluation

External Links

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