A Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Lysinate in Comparison to Ibuprofen Acid for Acute Postoperative Dental Pain.
Dental pain
Ibuprofen acid
Ibuprofen lysinate
Ibuprofen lysine
Pain intensity
Pain relief
Postoperative dental pain
Journal
Pain and therapy
ISSN: 2193-8237
Titre abrégé: Pain Ther
Pays: New Zealand
ID NLM: 101634491
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
received:
14
10
2019
pubmed:
9
1
2020
medline:
9
1
2020
entrez:
9
1
2020
Statut:
ppublish
Résumé
Ibuprofen acid is poorly soluble in the stomach, thus reaching maximum plasma levels at approximately 90 min post-dose. Ibuprofen lysinate has been developed to accelerate absorption of ibuprofen to shorten the time to analgesic efficacy. This study compared analgesic efficacy and onset of effect of a single dose of ibuprofen lysinate or ibuprofen acid in patients undergoing third molar extraction. Randomized, double-blind, placebo-controlled, multi-center, parallel-group single-dose study. Adults (18-60 years) undergoing extraction of ≥ 1 third molar were randomized 2:2:1 to ibuprofen lysinate, ibuprofen acid, or placebo postoperatively. Pain relief (PAR, 5-point scale, 0 = none to 4 = complete pain relief) and pain intensity (PI, 100 mm visual analog scale) were assessed between 15 and 360 min post-dose. The primary endpoint was the weighted sum of PAR scores at 6 h (TOTPAR). Time to onset of effect, global assessment of efficacy, and adverse events were also assessed. Overall, 351 patients received ibuprofen lysinate (N = 141), ibuprofen acid (N = 139), or placebo (N = 71). Both active treatments significantly reduced pain compared with placebo, from 15 min post-dose to 6 h (TOTPAR: ibuprofen lysinate: 19.57; ibuprofen acid: 19.96; placebo: 8.27). Ibuprofen lysinate was significantly more effective than placebo, but non-inferior to ibuprofen acid, at providing pain relief over 6 h. There was no significant difference between ibuprofen lysinate and ibuprofen acid for onset of analgesia. Both ibuprofen formulations were well tolerated; all adverse events were mild to moderate and considered unrelated to treatment. A single dose of ibuprofen lysinate is non-inferior to ibuprofen acid in terms of analgesic efficacy, onset of action, and tolerability in patients who have recently undergone dental surgery. EudraCT No. 2006-006942-33. Plain language summary available for this article.
Identifiants
pubmed: 31912434
doi: 10.1007/s40122-019-00148-1
pii: 10.1007/s40122-019-00148-1
pmc: PMC7203382
doi:
Types de publication
Journal Article
Langues
eng
Pagination
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