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

Not Applicable

Completed

• Conditions: Topic: Injuries and Emergencies; Subtopic: Injuries and Emergencies (all Subtopics); Disease: Injuries and Emergencies; Injury, Occupational Diseases, Poisoning; Injuries and emergencies

• Registration Number: ISRCTN25343280
• Lead Sponsor: Plymouth Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-04
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) Pain Score; Timepoint(s): hourly for 12 hours

Secondary Outcome Measures

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