Christensen 2011.

Study characteristics
Methods	Randomized, double‐blind, placebo and active controlled, parallel, single dose, multicenter. Efficacy monitored over 24 h postintervention; safety monitored over 9 days postintervention. Intervention administered at first report of moderate to severe postoperative pain.
Participants	Type of surgery: third molar extraction (1 or more extractions, 1 of which was a fully or partially impacted mandibular third molar requiring bone removal) Diclofenac 3.75 mg, 9.4 mg, 18.75 mg, 37.5 mg, and 75 mg groups Entered/completing: 51/51 for each group Age (mean, SD): not reported Sex (male, %): not reported Placebo group Entered/completing: 51/51 Age (mean, SD): not reported Sex (male, %): not reported Ketorolac group Entered/completing: 47/47 Age (mean, SD): not reported Sex (male, %): not reported
Interventions	Diclofenac: 3.75 mg, 9.4 mg, 18.75 mg, 37.5 mg, or 75 mg single IV bolus injection over 15 seconds Placebo: unspecified solution administered in same manner Ketorolac: 30 mg administered in same manner
Outcomes	Primary (as specified in study): TOTPAR over 0 h to 6 h in the ITT population Secondary: Time‐specific pain relief (VAS and categorical) Peak pain relief (VAS and categorical) SPID over 0 to 2, 0 to 4, 0 to 6, 0 to 8, 0 to 10, 0 to 12, and 0 to 24 hours (VAS and categorical) Time‐specific PID (VAS and categorical) Peak PID (VAS and categorical) Summed pain relief intensity differences (SPRID) over 0 to 2, 0 to 4, 0 to 6, 0 to 8, 0 to 10, 0 to 12, and 0 to 24 hours (VAS and categorical) Time to administration of rescue medication Proportion of patients requiring rescue medication Time to meaningful pain relief Time to perceptible pain relief Patient global evaluation Safety
Source of funding	Javelin Pharmaceuticals, Inc., Cambridge, MA (manufacturers of IV diclofenac, now Hospira, Inc., Lake Forest, IL following acquisition in 2010)
Were treatment groups comparable at baseline?	Yes: demographic (age, sex, ethnic origin, height, weight) and clinical (degree of molar impaction, surgical time and trauma, baseline pain) variables
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“computer‐generated randomization schedule”
Allocation concealment (selection bias)	Unclear risk	Not mentioned
Blinding of participants, personnel and outcome assessors	Low risk	“A third party doser who had no contact with patients except when dosing administered study treatment prepared the syringe with appropriate study treatment using a blind label within 1 hour of dosing”
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Intention‐to‐treat analysis performed on all participants for both efficacy and safety. Methods of data imputation not described.
Selective reporting (reporting bias)	Unclear risk	All outcomes specified in methods reported in results. Data and SDs not reported for all dose levels for every outcome.
Sample size	High risk	51 participants each in diclofenac group and placebo group, and 47 participants in ketorolac group