Severe pain after traumatic injury
Conditions
Interventions
Trade Name: Ketamine
Product Name: Ketamine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ketamine hydrochloride
CAS Number: 1867-66-9
Concentration unit: mg/ml milligram(s)/millil
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to determine whether paramedic administered ketamine or morphine provides more effective pain relief for patients reporting severe pain following trauma. This will be measured by using a 0-10 numeric rating scale and the Sum of Pain Intensity Difference (SPID).;Secondary Objective: Secondary objectives of the trial are to assess the effects of the paramedic administered ketamine and morphine on patient outcomes up to 6 months post injury. Specifically on overall pain relief and patient experience, including tolerability and longer term outcomes. We will review the resource used and cost effectiveness of each drug. ;Primary end point(s): Effectiveness of pain relief from randomisation to arrival at hospital as measured by Sum of Pain Intensity Difference (SPID) score (using a 0-10 numerical rating scale).;Timepoint(s) of evaluation of this end point: Following arrival at hospital. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effectiveness of pain relief and overall patient experience from randomisation to arrival at hospital - Total Pain Relief (TOTPAR) score - Time to perceptible analgesia - Time to meaningful analgesia - Time to peak analgesia - Duration of analgesia - Requirement for rescue analgesia - Proportion of patients with a pain intensity score below 4/10 (0-10 numerical rating scale (NRS)) on arrival at hospital - Vital signs (oxygen saturation, blood pressure, heart rate, respiration rate, Glasgow Coma Scale) - Patient Global Impression of Change on arrival at hospital Incidence of side effects and adverse events - Airway: vomiting, aspiration, advanced airway management - Respiratory: desaturation, need for ventilatory support - Cardiovascular: arrhythmia, hypotension and hypertension - Neurologic: sedation, excitatory movements, adverse behavioural reactions - Other: nausea, allergic reaction Resource use - Ambulance job cycle time (scene arrival to arrival at hospital) - Number of ambulance resources (technicians, paramedics, doctors and vehicles) in attendance - Cumulative IMP doses administered - CT scan use - Hospital or ICU admission - Length of stay ED, ICU, Hospital Longer term outcomes - Chronic pain using BPI-SF at 3 & 6 months from randomisation - Health-related quality of life EQ-5D-5L and CSRI at 3 and 6 months from randomisation - Cost-effectiveness expressed in terms of incremental cost per quality-adjusted life year (QALY) gained using EQ-5D 5L and CSRI (at 3 and 6 months post randomisation) ;Timepoint(s) of evaluation of this end point: After the 6 month follow up. | — |
Countries
United Kingdom
Contacts
Public ContactTrial Manager
University of Warwick Clinical Trials Unit
Outcome results
None listed