Criteria | Rationale |
---|---|
Patients over 75 years | Altered plasma levels of opioid in this age group for a given standard dose of PCA |
Patients with a reduced conscious level (Glasgow Coma Score <15) | Will not be able to give informed consent |
Inability to operate a PCA device | Will not be able to complete the intervention |
Patients who cannot understand the study information | For example due to pre-existing dementia, learning difficulties or intoxication. Will not be able to give informed consent |
Patients with chronic pain | Altered pain processing or opioid tolerance |
Patients who are opioid tolerant or have active opioid addiction | Abnormal response to opioids or potential opioid misuse |
Patients with a history of renal failure | Accumulation of active opioid metabolites |
Allergy or other contraindication to morphine | |
Hypotension (systolic blood pressure <90 mmHg) | Morphine may exacerbate hypotension |
Patients in police custody, or prisoners | |
Inability to gain intravenous access | Will not be able to receive intravenous morphine |
Patients who are likely to be definitively treated in the ED and discharged, or who are likely to require transfer for surgery direct from the ED | Will not be able to complete 12 h of VAS scoring |
Patients who are pregnant or breast-feeding | Altered drug metabolism and fetal/infant opioid effects |
Patients on other predetermined analgesia pathway | eg, regional anaesthesia |
Previous participation in this study | |
Current participation in another CTIMP |
CTIMP, clinical trial of an investigational medicinal product; ED, emergency department; PCA, patient controlled analgesia, VAS, visual analogue scale.