Table 2 Schedule of delivery of intervention and data collection
Visit | 1 | 2 | 3 | 4 |
|---|---|---|---|---|
Visit Window (No. Weeks ± No. Days) | Baseline/Pre hospital/Hospital arrival | After hospital arrival | 3 m (± 2w) | 6 m (± 1 m) |
Trial Information | ✓ | ✓ | ||
Informed consent | ✓ | |||
Randomisation | ✓ | |||
Vital signs | ✓ | |||
Inclusion/exclusion criteria | ✓ | |||
Intervention | ✓ | |||
Rescue analgesia | ✓ | |||
Quality of Life—EQ-5D-5L | ✓ | ✓ | ||
Side effects & Adverse events | ✓ | ✓ | ✓ | ✓ |
Questionnaire—BPI-SF | ✓ | ✓ | ||
Questionnaire—CSRI | ✓ | ✓ | ||
SPID | ✓ | |||
TOTPAR | ✓ | |||
Time to perceptible analgesia | ✓ | |||
Time to meaningful analgesia | ✓ | |||
Time to peak analgesia | ✓ | |||
Duration of analgesia | ✓ | |||
Patient Global Impression of Change | ✓ | |||
Resource use | ✓ | ✓ | ✓ | ✓ |