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Table 5 Safety and other outcomes

From: OPAL: a randomised, placebo-controlled trial of opioid analgesia for the reduction of pain severity in people with acute spinal pain—a statistical analysis plan

 

Opioid (n = xxx)

Placebo (n = xxx)

Fisher exact p value

Safety

 Serious adverse events (SAEs)

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

  Related SAEs

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

 Adverse events (AEs)

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

Healthcare utilisation

 Physiotherapy

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

 Imaging

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

 General practitioner

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

 Specialist doctor

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

 ED/hospitalisation

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

 Others

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

Use of concomitant medications

 Simple analgesia

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

 NSAID

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

 Combination opioid

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

 Strong opioid

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

 Others

nEVT nPAT (%)

nEVT nPAT (%)

0.xxx

Use of health services and concomitant medicines in patients reporting ongoing pain

 Week 26

n/N (%)

n/N (%)

0.xxx

 Week 52

n/N (%)

n/N (%)

0.xxx

At risk of misuse (scoring ≥9 on COMM)

 Week 12

n/N (%)

n/N (%)

0.xxx

 Week 26

n/N (%)

n/N (%)

0.xxx

 Week 52

n/N (%)

n/N (%)

0.xxx

  1. COMM Current Opioid Misuse Measure