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Patient controlled analgesia (PCA) versus routine care in the Emergency Department

An open randomised trial of patient controlled analgesia (PCA) versus routine care in the Emergency Department

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25343280
Enrollment
400
Registered
2011-07-04
Start date
2011-07-04
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Injuries and Emergencies

Interventions

Number of participants in each group - 400 total, i.e. 200 with non-traumatic abdominal pain and 200 with musculoskeletal injury, half of whom will receive PCA and half will receive standard care. Pa

Sponsors

Plymouth Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged between 18 and 75 years of age inclusive 2. Traumatic injuries or non-traumatic abdominal pain 3. In severe pain on arrival in the Emergency Department 4. Admission to hospital is intended at the time of enrolment 5. Provision of informed consent to participate.; Target Gender: Male & Female; Upper Age Limit 75 years ; Lower Age Limit 18 years

Exclusion criteria

Exclusion criteria: 1. Patients over 75 years 2. Patients with a reduced conscious level 3. Inability to operate a PCA device 4. Patients who cannot understand the study information (e.g. due to pre-existing dementia, learning difficulties, or intoxication) 5. Patients with chronic pain 6. Patients who are opioid tolerant 7. Patients with active opioid addiction 8. Patients with a history of renal failure 9. Allergy or other contraindication to morphine 10. Hypotension (systolic blood pressure <90mmHg) 11. Patients in police custody, or prisoners 12. Inability to gain intarvenous (IV) access 13. Patients who are likely to be definitively treated in the ED and discharged 14. Patients who are pregnant or breastfeeding 15. Open fractures (excluded because this group of patients will undergo surgery within six hours of injury according to national standards) 16. Patients on other predetermined analgesia pathway (e.g. regional anaesthesia) 17. Previous participation in this study 18. Current participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP)

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale (VAS) Pain Score; Timepoint(s): hourly for 12 hours

Secondary

MeasureTime frame
1. Total opioid dose and use of other analgesics 2. Opioid side-effects 3. Patient satisfaction with pain management 4. Proportion of study period with VAS >44mm 5. Proportion of study period spent sleeping 6. Length of hospital stay 7. Incremental cost effectiveness ratio (ICER)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026