passages: 3706
passages: document
passages: [ Double-blind placebo-controlled study of the effectiveness and tolerability of 10 and 30 mg ketorolac tromethamine suppositories in post-cholecystectomy pain ] . OBJECTIVE To evaluate the efficacy and tolerability of ketorolac tromethamine 10 mg and 30 mg suppositories in comparison to placebo , after single dose administration in patients suffering from post-operative pain after cholecystectomy . DESIGN Double-blind , randomized , controlled study . SETTING Anaesthesia Service . PATIENTS 99 patients with severe pain following surgery . INTERVENTIONS Cholecystectomy . MEASUREMENTS AND MAIN RESULTS The analgesia activity of ketorolac tromethamine 10 mg and 30 mg suppositories were evaluated after single dose administration by assessing pain intensity and pain relief using a 4 point scale ( VRS ) . At the end of the treatment period overall assessment of safety and efficacy were recorded by physician and patient . The results show that in both active groups after 30 ' and until 4 hours , pain intensity decreased significantly with respect to the baseline . However a statistically significant difference between groups of p < 0.02 , p < 0.01 and p < 0.05 was found in favour of the 30 mg dose respectively at 30 ' , 6 and 8 hours after administration . All the patients treated with placebo suppositories required another rescue analgesic drug and withdrew from the trial . Three patients complained adverse events not related to treatment : two on placebo and one on ketorolac 10 mg . The systemic and local tolerability of the drug was good . CONCLUSIONS This study shows that ketorolac 30 mg suppositories are effective in clinical conditions , such as after surgery , in which pain control must be achieved within the shortest time interval and maintained or improved by means of a single route of administration .
entities: 3707
entities: Intervention_Pharmacological
entities: ketorolac tromethamine
entities: 3708
entities: Intervention_Pharmacological
entities: ketorolac tromethamine
entities: 3709
entities: Intervention_Control
entities: placebo
entities: 3710
entities: Intervention_Pharmacological
entities: ketorolac tromethamine
entities: 3711
entities: Intervention_Control
entities: placebo
entities: 3712
entities: Intervention_Pharmacological
entities: ketorolac
entities: 3713
entities: Outcome_Other
entities: effectiveness
entities: 3714
entities: Outcome_Other
entities: tolerability
entities: 3715
entities: Outcome_Other
entities: efficacy
entities: 3716
entities: Outcome_Other
entities: tolerability
entities: 3717
entities: Outcome_Pain
entities: pain intensity and pain relief
entities: 3718
entities: Outcome_Pain
entities: 4 point scale ( VRS )
entities: 3719
entities: Outcome_Other
entities: safety
entities: 3720
entities: Outcome_Other
entities: efficacy
entities: 3721
entities: Outcome_Pain
entities: pain intensity
entities: 3722
entities: Outcome_Other
entities: rescue analgesic drug
entities: 3723
entities: Outcome_Adverse-effects
entities: adverse events
entities: 3724
entities: Outcome_Other
entities: systemic and local tolerability
entities: 3725
entities: Participant_Condition
entities: patients suffering from post-operative pain after cholecystectomy .
entities: 3726
entities: Participant_Sample-size
entities: 99
entities: 3727
entities: Participant_Condition
entities: patients with severe pain following surgery