@entity4829 with @entity5018 versus XXXX alone in @entity697 : a randomized, double-blind clinical trial.

@entity1 @entity697 @entity4829 @entity5018 @entity2613 @entity158 @entity130
STUDY OBJECTIVE: We evaluate the analgesic and side effects of adding @entity4829 to @entity5018 in emergency department @entity1 with @entity697 . METHODS: A randomized, prospective, double-blind study was conducted at an urban teaching @entity2613 with an annual census of 44,000. One hundred two @entity1 aged 18 to 70 years with @entity697 caused by minor @entity130 within the prior 48 hours were included, and 77 @entity1 completed the protocol. Each @entity1 received a single dose of 800 mg of @entity5018 in the @entity2613 and a vial of 6 capsules containing 800 mg of @entity5018 to take every 8 hours as needed after discharge from the @entity2613 . In addition, 51 @entity1 received a single dose of 10 mg of @entity4829 and a vial of 6 capsules containing 10 mg of @entity4829 to take every 8 hours as needed after discharge from the @entity2613 ; the remaining 51 @entity1 received an identically labeled placebo capsule and vial of placebo capsules to take every 8 hours as needed after discharge from the @entity2613 . @entity1 rated the intensity of their @entity158 on a 100-mm visual analog scale (VAS) at baseline; 30, 60, 90, 120, and 180 minutes; and 24 and 48 hours after treatment. Telephone follow-up was obtained at 24 and 48 hours, and side effects were elicited at 24 and 48 hours by means of open-ended questioning. RESULTS: The @entity1 in each group were similar with regard to diagnosis and baseline @entity158 score. The number of @entity1 who did not complete the protocol and the number of those who required additional analgesia were similar in both groups. Over the 48 hours of the protocol, the mean VAS score for the combination group decreased from 60.4 to 35.6, and the mean VAS score for the @entity5018 alone group decreased from 62.2 to 35.4. The mean VAS scores between groups across time was not statistically significant (P =.962, repeated-measures analysis of variance). At both 24 and 48 hours, central nervous system side effects were reported more frequently in the @entity1 receiving @entity4829 (16 [42%] versus 7 [18%] at 24 hours and 15 [39%] versus 5 [13%] at 48 hours, respectively). CONCLUSION: In @entity2613 @entity1 with @entity697 , the addition of @entity4829 to @entity5018 does not improve analgesia but is associated with a greater prevalence of central nervous system side effects.
