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

SOMBOON THIENTHONG, MD*, WIMONRA T KRISANAPRAKORNKIT, MD*, WORRANUT TAESIRI, BSc*, NUANCHAN THANINSURAT , BSc**, SIRIPORN UTSAHAPANICH, BSc**, CHONGSUK KLAICHANAD, BSc*

Affiliation : *Department of Anesthesiology, **Surgical Ward Nurse, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.

AbstractBackground : Tramadol is a weak opioid agonist with antinociceptive effects through its action on the J.l-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 admi nistered 12 hours later by nurses not apprised of the patient groupings. All patients received the stan dard 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 postanes thesia care unit (PACU) (T and 2 (T 6 (T 12 (T and 24 (T hours after surgery. Rescue anal ) ), ), ) ) 0 2 6 12 24 gesia 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 rV AS and mV AS) at each measurement period were not significantly different between the groups except for the m VAS at T , where the proportion in 24 = group Twas higher than group P (48% vs 20%, 95% CI of difference: -53%, -3%, p 0.04). The median morphine consumption in both groups at T , T , T and T were comparable. No serious adverse 2 6 12 24 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.

Keywords : Sustained-release tramadol, Mastectomy, Post-operative pain, Morphine

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