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	72
Intervention A	36
Intervention B	36

6. Number Analyzed


Total	70
Intervention A	36
Intervention B	34

7. Participants age (mean, years)


	26

8. Participants sex (% Female)


	56

9. Race (%)

Column L


	Not reported

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


	Not reported

15. Overall Baseline Pain Standardized Scale 0 to 10

Column S


	0.72 to 0.85

16. Treatment duration

Column T


	48 hours

17. Assessment Time Points

Column V

18. Duration of Followup Category

Column W

Arms

Arm Name	Arm Description
Intervention A	Tramadol 75 mg + dexketoprofen 25 mg oral, every 8 hours up to 48 hours post-surgery
Intervention B	Ibuprofen 400 mg every 8 hours oral, every 8 hours up to 48 hours post-surgery

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Continuous	Pain	Pain intensity (mean [95% CI] 0 to 10 VAS)	All Participants	4 hours 6 hours 12 hours 24 hours
Categorical	QOL and Satisfaction With Pain Relief	Perception of medication good or very good	All Participants	End of Study
Categorical	Adverse Events	Any adverse event	All Participants	End of Study
Categorical	Adverse Events	Any serious adverse event	All Participants	End of Study
Categorical	Adverse Events	Nausea	All Participants	End of Study
Categorical	Adverse Events	Vomiting	All Participants	End of Study
Categorical	Adverse Events	Somnolence	All Participants	End of Study
Categorical	Adverse events	Dizziness	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

QOL and Satisfaction With Pain Relief (Perception of medication good or very good)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Intervention A	Intervention B		Intervention A (Tramadol 75...) vs. Intervention B (Ibuprofen 400...)
End of Study
	Total (N analyzed)			Risk Ratio (RR)
	Events			95% CI low (RR)
				95% CI high (RR)
		Within Arm Comparisons			Net Comparisons
		Intervention A	Intervention B		Intervention A (Tramadol 75...) vs. Intervention B (Ibuprofen 400...)

Adverse Events (Any adverse event)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Intervention A	Intervention B
End of Study
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
				95% CI high (OR)
				Risk Ratio (RR)
				95% CI low (RR)
				95% CI high (RR)
				p value
		Within Arm Comparisons			Net Comparisons
		Intervention A	Intervention B

Adverse Events (Any serious adverse event)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Intervention A	Intervention B
End of Study
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
	Percentage			95% CI high (OR)
				Risk Ratio (RR)
				95% CI low (RR)
				95% CI high (RR)
				p value
		Within Arm Comparisons			Net Comparisons
		Intervention A	Intervention B

Adverse Events (Nausea)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Intervention A	Intervention B
End of Study
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
				95% CI high (OR)
				Risk Ratio (RR)
				95% CI low (RR)
				95% CI high (RR)
				p value
		Within Arm Comparisons			Net Comparisons
		Intervention A	Intervention B

Adverse Events (Vomiting)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Intervention A	Intervention B
End of Study
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
				95% CI high (OR)
				Risk Ratio (RR)
				95% CI low (RR)
				95% CI high (RR)
				p value
		Within Arm Comparisons			Net Comparisons
		Intervention A	Intervention B

Adverse Events (Somnolence)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Intervention A	Intervention B
End of Study
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
				95% CI high (OR)
				Risk Ratio (RR)
				95% CI low (RR)
				95% CI high (RR)
				p value
		Within Arm Comparisons			Net Comparisons
		Intervention A	Intervention B

Adverse events (Dizziness)

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Intervention A	Intervention B
End of Study
	Total (N analyzed)			Odds Ratio (OR)
	Events			95% CI low (OR)
				95% CI high (OR)
				Risk Ratio (RR)
				95% CI low (RR)
				95% CI high (RR)
				p value
		Within Arm Comparisons			Net Comparisons
		Intervention A	Intervention B

Continuous

Pain (Pain intensity (mean [95% CI] 0 to 10 VAS))

All Participants
		Descriptive Statistics			Between Arm Comparisons
		Intervention A	Intervention B
4 hours
	Mean			Mean Difference (MD)
	95% CI low			95% CI low (MD)
	95% CI high			95% CI high (MD)
				SD (MD)
				p value (MD)
6 hours
	Mean			Mean Difference (MD)
	95% CI low			95% CI low (MD)
	95% CI high			95% CI high (MD)
				SD (MD)
				p value (MD)
12 hours
	Mean			Mean Difference (MD)
	95% CI low			95% CI low (MD)
	95% CI high			95% CI high (MD)
				SD (MD)
				p value (MD)
24 hours
	Mean			Mean Difference (MD)
	95% CI low			95% CI low (MD)
	95% CI high			95% CI high (MD)
				SD (MD)
				p value (MD)
		Within Arm Comparisons			Net Comparisons
		Intervention A	Intervention B

Extraction form for project: Acute Pain Updates

Design Details

1. Setting

2. Country

3. Specific Pain Condition

4. Intervention Types Compared

5. Number randomized

6. Number Analyzed

7. Participants age (mean, years)

8. Participants sex (% Female)

9. Race (%)

10. History of Substance Use Disorder

11. Under Treatment for Opiate Use Disorder

12. History of Psychiatric Illness

13. Pregnant or Breastfeeding

14. Pain Duration

15. Overall Baseline Pain Standardized Scale 0 to 10

16. Treatment duration

17. Assessment Time Points

18. Duration of Followup Category

Arms

Arm Details

Sample Characteristics

Outcomes

Outcome Details

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?

9. Was there intention-to-treat analysis?

10. Were there post-randomization exclusions?

11. Were the outcomes prespecified?

12. Quality rating

Results

Categorical

QOL and Satisfaction With Pain Relief (Perception of medication good or very good)

Adverse Events (Any adverse event)

Adverse Events (Any serious adverse event)

Adverse Events (Nausea)

Adverse Events (Vomiting)

Adverse Events (Somnolence)

Adverse events (Dizziness)

Continuous

Pain (Pain intensity (mean [95% CI] 0 to 10 VAS))