Two doses of oral sustained-release tramadol do not reduce pain or morphine consumption after modified radical mastectomy: a randomized, double blind, placebo-controlled trial.

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dc.contributor.authorThienthong, Somboonen_US
dc.contributor.authorKrisanaprakornkit, Wimonraten_US
dc.contributor.authorTaesiri, Worranuten_US
dc.contributor.authorThaninsurat, Nuanchanen_US
dc.contributor.authorUtsahapanich, Siripornen_US
dc.contributor.authorKlaichanad, Chongsuken_US
dc.date.accessioned2009-05-27T21:58:00Z
dc.date.available2009-05-27T21:58:00Z
dc.date.issued2004-01-20en_US
dc.descriptionChotmaihet Thangphaet.en_US
dc.description.abstractBACKGROUND: Tramadol is a weak opioid agonist with antinociceptive effects through its action on the mu-receptor and by inhibiting the neuronal re-uptake of both noradrenaline and serotonin. Tramadol is commonly used for treatment of mild to moderate post-operative pain. An oral form of sustained-release tramadol (SR) was recently formulated for reducing the administration frequency from qid to bid. OBJECTIVE: To evaluate the analgesic efficacy and safety of two doses of oral tramadol SR for the treatment of pain after modified radical mastectomy. STUDY DESIGN: Randomized, double blind, placebo-controlled trial. METHOD: Fifty women were randomly allocated to receive either tramadol SR 100 mg (group T), or placebo tablet (group P) orally approximately 1 hour before surgery with a repeat dose administered 12 hours later by nurses not apprised of the patient groupings. All patients received the standard general anesthesia. Post-operatively, nurses in the research team assessed pain using a visual analog scale 0-100 mm at rest (rVAS) and during arm movements (mVAS) at admission to postanesthesia care unit (PACU) (T0) and 2 (T2), 6 (T6), 12 (T12) and 24 (T24) hours after surgery. Rescue analgesia was provided for 24 hours via a morphine-loaded patient-controlled analgesia (PCA) device at 1 mg bolus with a 5-minute lockout interval. Cumulative morphine consumption and adverse events were recorded. RESULTS: Twenty-five patients with comparable baseline characteristics from each group were studied. The proportions of patients with VAS > 30 (both rVAS and mVAS) at each measurement period were not significantly different between the groups except for the mVAS at T24, where the proportion in group T was higher than group P (48% vs 20%, 95% CI of difference: -53%, -3%, p = 0.04). The median morphine consumption in both groups at T2, T6, T12 and T24 were comparable. No serious adverse effects were observed; however, patients in group T reported nausea and vomiting more than group P (56% vs 24%, p = 0.02). CONCLUSION: Two doses of oral tramadol SR 100 mg had no effect on post-operative pain scores and morphine consumption in patients who underwent modified radical mastectomy. In fact, more patients in the tramadol group reported nausea and vomiting than the placebo group.en_US
dc.description.affiliationDepartment of Anesthesiology, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.en_US
dc.identifier.citationThienthong S, Krisanaprakornkit W, Taesiri W, Thaninsurat N, Utsahapanich S, Klaichanad C. Two doses of oral sustained-release tramadol do not reduce pain or morphine consumption after modified radical mastectomy: a randomized, double blind, placebo-controlled trial. Journal of the Medical Association of Thailand. 2004 Jan; 87(1): 24-32en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/45714
dc.language.isoengen_US
dc.source.urihttps://www.mat.or.th/journal/all.phpen_US
dc.subject.meshAdministration, Oralen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshAnalgesics, Opioid --administration & dosageen_US
dc.subject.meshBreast Neoplasms --surgeryen_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshMastectomy, Modified Radical --adverse effectsen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshMorphine --administration & dosageen_US
dc.subject.meshPain, Postoperative --drug therapyen_US
dc.subject.meshTramadol --administration & dosageen_US
dc.subject.meshTreatment Outcomeen_US
dc.titleTwo doses of oral sustained-release tramadol do not reduce pain or morphine consumption after modified radical mastectomy: a randomized, double blind, placebo-controlled trial.en_US
dc.typeClinical Trialen_US
dc.typeJournal Articleen_US
dc.typeRandomized Controlled Trialen_US
dc.typeResearch Support, Non-U.S. Gov'ten_US
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