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 AHydrocodone10 mg + acetaminophen 650 mg oral, single dose
Intervention BNaproxen sodium 440 mg oral, single dose

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainPain intensity (mean difference from baseline [SD NR], 0 to 10 NRS, estimated from graph)
  • All Participants
  • 4 hours after treatment
  • 6 hours after treatment
  • 12 hours after treatment
CategoricalAdverse EventsAny adverse event
  • All Participants
  • End of study
CategoricalAdverse EventsNausea
  • All Participants
  • End of study
CategoricalAdverse EventsVomiting
  • All Participants
  • End of study
CategoricalAdverse eventsDizziness
  • All Participants
  • End of study
CategoricalAdverse eventsHeadache
  • All Participants
  • End of study
CategoricalAdverse EventsSomnolence
  • All Participants
  • End of study
CategoricalWithdrawal due to adverse events
  • All Participants
  • End of 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


Adverse Events (Any adverse event)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
End of study
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B

Adverse Events (Nausea)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
End of study
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B

Adverse Events (Vomiting)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
End of study
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B

Adverse events (Dizziness)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
End of study
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B

Adverse events (Headache)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
End of study
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B

Adverse Events (Somnolence)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
End of study
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B

Withdrawal due to adverse events

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
End of study
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B

Continuous


Pain (Pain intensity (mean difference from baseline [SD NR], 0 to 10 NRS, estimated from graph))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
4 hours after treatment
Mean difference from baseline
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
6 hours after treatment
Mean difference from baseline
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
12 hours after treatment
Mean difference from baseline
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B