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 ATramadol 25 mg/diclofenac 25 mg oral, 3 doses over 24 hours
Intervention BTramadol 50 mg/diclofenac 50 mg oral, 3 doses over 24 hours
Intervention CTramadol 50 mg oral, 3 doses over 24 hours
Intervention DDiclofenac 50 mg oral, 3 doses over 24 hours

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainSum of pain intensity differences (mean [SD], sum of differences on 0 to 10 NRS)
  • All Participants
  • 0 to 4 hours
  • 0 to 6 hours
  • 0 to 24 hours
ContinuousPainPain intensity difference (least mean square [SD NR], 0 to 10 NRS, estimated from graph)
  • All Participants
  • 4 hours
  • 6 hours
  • 24 hours
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
CategoricalWithdrawals Due to Adverse Events
  • All Participants
  • End of study
CategoricalQOL and Satisfaction With Pain ReliefGlobal assessment very good or excellent:
  • All Participants
  • 24 hours
  • 8 hours

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 BIntervention CIntervention D
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 BIntervention CIntervention D

Adverse Events (Nausea)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention BIntervention CIntervention D
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 BIntervention CIntervention D

Adverse Events (Vomiting)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention BIntervention CIntervention D
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 BIntervention CIntervention D

Adverse events (Dizziness)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention BIntervention CIntervention D
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 BIntervention CIntervention D

Withdrawals Due to Adverse Events

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention BIntervention CIntervention D
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 BIntervention CIntervention D

QOL and Satisfaction With Pain Relief (Global assessment very good or excellent:)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention BIntervention CIntervention D
24 hours
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
95% CI high (OR)
p value
8 hours
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Intervention AIntervention BIntervention CIntervention D

Continuous


Pain (Sum of pain intensity differences (mean [SD], sum of differences on 0 to 10 NRS))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention BIntervention CIntervention D
0 to 4 hours
Least mean square
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
0 to 6 hours
Least mean square
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
0 to 24 hours
Least mean square
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Intervention AIntervention BIntervention CIntervention D

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

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention BIntervention CIntervention D
4 hours
Least mean square
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
6 hours
Least mean square
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
24 hours
Least mean square
Mean Difference (MD)
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Intervention AIntervention BIntervention CIntervention D