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http://hdl.handle.net/2445/174986
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DC Field | Value | Language |
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dc.contributor.author | Gay Escoda, Cosme | - |
dc.contributor.author | Hanna, Magdi | - |
dc.contributor.author | Montero, Antonio | - |
dc.contributor.author | Dietrich, Thomas | - |
dc.contributor.author | Milleri, Stefano | - |
dc.contributor.author | Giergiel, Ewa | - |
dc.contributor.author | Zoltán, Tóth Bagi | - |
dc.contributor.author | Varassi, Giustino | - |
dc.date.accessioned | 2021-03-12T12:35:05Z | - |
dc.date.available | 2021-03-12T12:35:05Z | - |
dc.date.issued | 2019-02-19 | - |
dc.identifier.issn | 2044-6055 | - |
dc.identifier.uri | http://hdl.handle.net/2445/174986 | - |
dc.description.abstract | Objectives: To compare efficacy/safety of oral tramadol 75 mg/dexketoprofen 25 mg (TRAM/DKP) and TRAM 75 mg/paracetamol 650 mg (TRAM/paracetamol) in moderate to severe pain following surgical removal of impacted lower third molar. Design: Multicentre, randomised, double-blind, placebo-controlled, phase IIIb study. Participants: Healthy adult patients scheduled for surgical extraction of at least one fully/partially impacted lower third molar requiring bone manipulation. 654 patients were randomised and 653 were eligible for analysis. Interventions: Surgery was performed under local anaesthetic. No sedation was permitted. Patients rated pain intensity (PI) using an 11-Numerical Rating Scale (NRS) (0 no pain; 10 worst pain). Participants experiencing moderate/severe pain (≥4) within 4 hours of surgery were randomised (2:2:1 ratio) to a single oral dose of TRAM/DKP 75/25 mg, TRAM/paracetamol 75/650 mg or placebo. Main outcome measures: Efficacy was based patients' electronic diaries. Analgesia and pain were recorded as follows: pain relief (PAR) on a 5-point Verbal Rating Scale (0='no relief', 1='a little (perceptible) relief', 2='some (meaningful) relief', 3='lot of relief', 4='complete relief') at the predefined postdose time points t15 min, t30 min, t1 hour, t1.5 hour, t2 hour, t4 hour, t6 hour and t8 hour and PI on the 11-point NRS at t0 and at the same predefined postdose time points. Onset of analgesia documented using double stopwatch method over a 2-hour period. Primary endpoint was total pain relief over 6 hours (TOTPAR6). Rescue medication was available during the treatment period. Results: TRAM/DKP was superior to TRAM/paracetamol and placebo at the primary endpoint TOTPAR6 (p<0.0001). Mean (SD) TOTPAR6 in the TRAM/DKP group was 13 (6.97), while those in the active control and placebo groups were 9.2 (7.65) and 1.9 (3.89), respectively. Superiority of TRAM/DKP over active comparator and placebo was observed at all secondary endpoints. Incidence of adverse events was comparable between active groups. Conclusions: TRAM/DKP (75/25 mg) is effective and superior to TRAM/paracetamol (75/650 mg) in relieving moderate to severe acute pain following surgical removal of impacted lower third molar, with a faster onset of action, greater and durable analgesia, together with a favourable safety profile. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | BMJ Publishing Group | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1136/bmjopen-2018-023715 | - |
dc.relation.ispartof | BMJ Open, 2019, vol. 9, num. e023715 | - |
dc.relation.uri | https://doi.org/10.1136/bmjopen-2018-023715 | - |
dc.rights | cc-by (c) Gay Escoda, Cosme et al., 2019 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es | - |
dc.source | Articles publicats en revistes (Odontoestomatologia) | - |
dc.subject.classification | Assaigs clínics | - |
dc.subject.classification | Tractament del dolor | - |
dc.subject.other | Clinical trials | - |
dc.subject.other | Pain treatment | - |
dc.title | Tramadol/dexketoprofen (TRAM/DKP) compared with tramadol/paracetamol in moderate to severe acute pain: results of a randomised, double-blind, placebo and active-controlled, parallel group trial in the impacted third molar extraction pain model (DAVID study) | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 698804 | - |
dc.date.updated | 2021-03-12T12:35:06Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 30782886 | - |
Appears in Collections: | Articles publicats en revistes (Odontoestomatologia) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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698804.pdf | 2.91 MB | Adobe PDF | View/Open |
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