Patients presenting to the Emergency Department in severe pain from either musculoskeletal injury or non-traumatic abdominal pain.
Conditions
Interventions
Trade Name: Morphine Sulphate Injection 1mg/ml
Pharmaceutical Form: Injection
INN or Proposed INN: Morphine Sulphate
Concentration unit: mg/ml milligram
Sponsors
Plymouth Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Adult patients aged between 18 and 75 years of age inclusive. •Traumatic injuries or non-traumatic abdominal pain. •In severe pain on arrival in the Emergency Department. •Admission to hospital is intended at the time of enrolment. •Provision of informed consent to participate. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: •Patients over 75 years •Patients with a reduced conscious level •Inability to operate a PCA device. •Patients who cannot understand the study information (e.g. due to pre-existing dementia, learning difficulties, or intoxication). •Patients with chronic pain. •Patients who are opioid tolerant. •Patients with active opioid addiction. •Patients with a history of renal failure. •Allergy or other contraindication to morphine. •Hypotension (systolic blood pressure <90mmHg). •Patients in police custody, or prisoners. •Inability to gain IV access. •Patients who are likely to be definitively treated in the ED and discharged. •Patients who are pregnant or breast-feeding. •Open fractures (excluded because this group of patients will undergo surgery within six hours of injury according to national standards). •Patients on other predetermined analgesia pathway (e.g. regional anaesthesia). •Previous participation in this study. •Current participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In adult emergency patients with severe pain, who are subsequently admitted to a hospital ward, does patient controlled analgesia (PCA) improve pain relief during an initial 12 hour period compared to standard care, as measured by a self-reported visual analogue scale (VAS) pain score?;Secondary Objective: •Is there a difference in total analgesia use between the two groups? •Is there any increase in side effects when PCA is used compared to standard care? •Is there a difference between the two groups in patient satisfaction with their pain management? •Is there a difference between the two groups in the proportion of the study period with VAS > 44mm? •Is there a difference in the proportion of time spent sleeping between the two groups? •Is length of hospital stay different between the two groups? •Is there a differential clinical effectiveness of PCA between the abdominal and traumatic pain groups? •Is PCA cost effective in this setting and for this group of patients?;Primary end point(s): The primary outcome measure is the visual analogue pain rating scale (VAS) as a unidimensional measure of pain. Participants will record VAS scores at 60-minute intervals over a 12 hour period. Periods of sleep will also be recorded by the participant. The primary analysis will use the AUC formed by joining the dots of the recorded serial VAS measurements giving a measure of overall pain experienced during the study period. A secondary analysis will score pain as 0mm when asleep and repeat the AUC analysis. | — |
Countries
United Kingdom
Contacts
Public ContactChris Hayward
Peninsula Clinical Trials Unit (Plymouth University)
Outcome results
None listed