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Original ArticleOpen Access
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
Thienthong S 
,
Krisanaprakornkit W ,
Taesiri W ,
Thaninsurat N ,
Utsahapanich S ,
Klaichanad C
,
Krisanaprakornkit W ,
Taesiri W ,
Thaninsurat N ,
Utsahapanich S ,
Klaichanad C Background : 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
0
)
and 2 (T
2
),
6 (T
6
),
12 (T
12
)
and 24 (T
24
)
hours after surgery. Rescue anal-
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 m VAS) at each measurement period
were not significantly different between the groups except for the m VAS at T
24
,
where the proportion in
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
2
,
T
6
,
T
12
and T
24
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).
Vol.87 No.I
ORAL TRAMAL RETARD DO NOT RECUCE PAIN AFI'ER MASTECTOMY
2S
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.
Key word : Sustained-release tramadol, Mastectomy, Post-operative pain, Morphine
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
0
)
and 2 (T
2
),
6 (T
6
),
12 (T
12
)
and 24 (T
24
)
hours after surgery. Rescue anal-
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 m VAS) at each measurement period
were not significantly different between the groups except for the m VAS at T
24
,
where the proportion in
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
2
,
T
6
,
T
12
and T
24
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).
Vol.87 No.I
ORAL TRAMAL RETARD DO NOT RECUCE PAIN AFI'ER MASTECTOMY
2S
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.
Key word : Sustained-release tramadol, Mastectomy, Post-operative pain, Morphine
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