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document
A randomized , double-blind , placebo-controlled comparison of the analgesic efficacy , onset of action , and tolerability of ibuprofen arginate and ibuprofen in postoperative dental pain . BACKGROUND Because of its enhanced pharmacokinetic characteristics , ibuprofen arginate might be expected to provide faster pain relief than standard ibuprofen formulations in patients experiencing acute pain . OBJECTIVE This study assessed the analgesic efficacy , speed of onset , and tolerability of ibuprofen arginate compared with a commercially available form of ibuprofen in patients with postoperative dental pain . METHODS Patients were randomized to receive ibuprofen arginate 200 or 400 mg , ibuprofen 200 or 400 mg , or placebo in this multicenter , double-blind , double-dummy , parallel-group trial . Patients were observed for 6 hours after administration of a single dose of study medication . A repeated-dose , open-label phase followed . Pain intensity and pain relief were measured using traditional verbal descriptor scales ; onset of analgesia was assessed using 2 stopwatches to measure the time to achievement of specific pain relief criteria . RESULTS A total of 498 patients ( 219 men , 279 women ; mean age , 21.5 years ) participated in this study . Baseline pain was moderate in 388 patients ( 78 % ) and severe in 110 patients ( 22 % ) . Meaningful pain relief was reached after a median of 29 and 28 minutes with ibuprofen arginate 200 and 400 mg , respectively , and after 52 and 44 minutes with ibuprofen 200 and 400 mg , respectively ( all , P < 0.05 ) . The percentages of patients who achieved meaningful pain relief within the first hour after treatment were 77.6 % and 83.7 % for ibuprofen arginate 200 and 400 mg , respectively , 61.0 % and 63.0 % for ibuprofen 200 and 400 mg , respectively , and 39.8 % for placebo . The differences between ibuprofen arginate and ibuprofen were statistically significant ( both doses , P < 0.05 ) . Significantly greater numbers of patients achieved meaningful pain relief with ibuprofen arginate 400 mg compared with placebo from 20 minutes through 6 hours and with ibuprofen arginate 200 mg from 30 minutes through 6 hours ( P < 0.05 ) . Compared with placebo , a greater number of patients achieved meaningful pain relief with ibuprofen 400 mg from 45 minutes through 6 hours ; with ibuprofen 200 mg. the corresponding interval was from I through 6 hours . After the first hour , pain reduction was similar for the similar doses of the 2 ibuprofen preparations . Median remedication times with both doses of ibuprofen arginate were similar to those with both doses of ibuprofen , ranging from 4.0 to 5.2 hours . Adverse-event profiles were similar between the 2 active medications . CONCLUSIONS Ibuprofen arginate was effective in this population of patients experiencing moderate to severe pain after surgical extraction of > or = 1 impacted third molar , with 16 to 24 minutes ' faster time to meaningful pain relief than with ibuprofen . The 2 formulations had similar tolerability profiles .
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Intervention_Pharmacological
ibuprofen arginate
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Intervention_Pharmacological
ibuprofen
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Intervention_Pharmacological
ibuprofen arginate
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Intervention_Pharmacological
standard ibuprofen
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Intervention_Pharmacological
ibuprofen arginate 200 or 400 mg , ibuprofen 200 or 400 mg ,
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Intervention_Control
placebo
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Intervention_Pharmacological
ibuprofen arginate
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Intervention_Pharmacological
ibuprofen
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Intervention_Pharmacological
ibuprofen arginate
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Intervention_Pharmacological
ibuprofen
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Intervention_Pharmacological
ibuprofen arginate
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Intervention_Control
placebo
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Intervention_Pharmacological
ibuprofen
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Intervention_Pharmacological
ibuprofen
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Intervention_Pharmacological
ibuprofen arginate
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Intervention_Pharmacological
Ibuprofen arginate
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Outcome_Pain
analgesic efficacy
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Outcome_Other
, onset of action
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Outcome_Other
tolerability
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Outcome_Other
pharmacokinetic characteristics
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Outcome_Pain
pain relief
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Outcome_Pain
analgesic efficacy
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Outcome_Other
, speed of onset , and tolerability
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Outcome_Pain
Pain intensity and pain relief
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Outcome_Pain
verbal descriptor scales ; onset of analgesia
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Outcome_Pain
time to achievement of specific pain relief
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Outcome_Pain
Baseline pain
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Outcome_Pain
pain relief
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Outcome_Pain
pain relief
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Outcome_Pain
pain relief
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Outcome_Pain
pain relief
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Outcome_Pain
pain reduction
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Outcome_Physical
Median remedication times
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Outcome_Adverse-effects
Adverse-event profiles
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Outcome_Pain
pain relief
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Outcome_Other
tolerability
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Participant_Condition
postoperative dental pain .
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Participant_Condition
acute pain .
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Participant_Condition
postoperative dental pain
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Participant_Sample-size
498
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Participant_Sample-size
219
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Participant_Sex
men
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Participant_Sample-size
279
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Participant_Sex
women
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Participant_Age
21.5