Extraction form for project: Acute Pain Updates

Design Details

1. Setting
Column B
2. Country
Column C
3. Specific Pain Condition
Column D
4. Intervention Types Compared
Column E
5. Number randomized
Total
Intervention A
Intervention B
6. Number Analyzed
Total
Intervention A
Intervention B
7. Participants age (mean, years)
8. Participants sex (% Female)
9. Race (%)
Column L
10. History of Substance Use Disorder
Column N
11. Under Treatment for Opiate Use Disorder
Column O
12. History of Psychiatric Illness
Column P
13. Pregnant or Breastfeeding
Column R
14. Pain Duration
Column R
15. Overall Baseline Pain Standardized Scale 0 to 10
Column S
16. Treatment duration
Column T
17. Assessment Time Points
Column V
18. Duration of Followup Category
Column W

Arms

Arm NameArm Description
Intervention AOxycodone controlled release 10 mg twice daily for 6 days
Intervention BTapentadol extended release 50 mg twice daily for 6 days

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainPain on mobilization (mean [SD], 0 to 10 VAS)
  • All Participants
  • Day 1 after treatment
  • Day 14 after treatment
  • 8 week after treatment
ContinuousPainPain at rest (mean [SD], 0 to 10 VAS)
  • All Participants
  • Day 1 after treatment
  • Day 14 after treatment
  • 8 week after treatment
CategoricalWithdrawal due to adverse events
  • All Participants
  • During study

Outcome Details

N/A

Risk of Bias Assessment

1. Was randomization adequate?
2. Was allocation concealment adequate?
3. Were the groups similar at baseline?
4. Were the outcome assessor masked?
5. Were the care providers masked?
6. Was the patient masked?
7. Did the article report attrition, crossovers, adherence and/or contamination?
8. Loss to followup?
Differential
High
9. Was there intention-to-treat analysis?
10. Were there post-randomization exclusions?
11. Were the outcomes prespecified?
12. Quality rating

Results

Categorical


Withdrawal due to adverse events

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
Intervention A (Oxycodone...)
vs.
Intervention B (Tapentadol...)
During study
Total (N analyzed)
Risk Ratio (RR)
Events
95% CI low (RR)
95% CI high (RR)
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B
Intervention A (Oxycodone...)
vs.
Intervention B (Tapentadol...)

Continuous


Pain (Pain on mobilization (mean [SD], 0 to 10 VAS) )

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
Day 1 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Day 14 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
8 week after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B

Pain (Pain at rest (mean [SD], 0 to 10 VAS))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
Day 1 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Day 14 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
8 week after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B