Paramedic given pain relief comparing the use of ketamine and morphine in trauma

Phase 1

• Conditions: Severe pain after traumatic injury; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2020-000154-10-GB
• Lead Sponsor: niversity of Warwick

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-19
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

- Age 16 years or over
- Patient reports a pain score =7/10 on a 0-10 NRS following acute traumatic injury
- Intravenous or intraosseous access obtained
- Determined by a paramedic to require IV morphine or equivalent

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 246
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Known or suspected pregnancy
- Unable to articulate severity of pain using the 0-10 NRS
- Lack of capacity due to a reason other than pain
- Ketamine or opioid analgesia prior to randomisation
- Known contraindication to either ketamine or morphine as per the SmPC
- Patient declines participation
- Known prisoner

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified