1. Optimizing postoperative pain con-
trol is an important aspect in peri-
operative patient care. Wound infiltration
with local anesthetics has been the pre-
ferred analgesic method since the early
20th century.1
Local anesthetic effects of
opioids have been demonstrated in sev-
eral studies; tramadol is an analgesic
with different spectrums of activity.2
It
causes the activation of both opioid and
nonopioid (descending monoaminergic)
systems, which are mainly involved in
the inhibition of pain. The effect of the
nonopioid component of tramadol is me-
diated through α2
agonistic and seroton-
ergic activities by inhibiting the reuptake
of the norepinephrine and 5-hydroxy-
tryptamine, and possibly by displacing
stored 5-hydroxytryptamine from nerve
endings.3,4
Moreover, as a weak opioid,
tramadol is a centrally acting analgesic
selective for µ-receptors, with local anes-
thetic actions on peripheral nerves.5
The postoperative analgesic effects of
subcutaneous wound infiltration with
tramadol have not been extensively stud-
ied and compared with those of intra-
venous administration; therefore, the aim
The Annals of Pharmacotherapy I 2009 March, Volume 43 I
Subcutaneous Tramadol Infiltration at the Wound Site Versus
Intravenous Administration after Pyelolithotomy
Mohammad Reza Khajavi, Seyed Babak Mojaver Aghili, Reza Shariat Moharari, Atabak Najafi,
Robab Mohtaram, Patricia Khashayar, and Mojtaba Mojtahedzade
www.theannals.com
Pain Management
Author information provided at the end of the
text.
RESEARCH REPORTS
BACKGROUND: Recently, the peripheral anesthetic effect of tramadol has been
the theme of many studies. The postoperative analgesic effects of subcutaneous
wound infiltration with tramadol have not been extensively studied and compared
with those of intravenous administration.
OBJECTIVE: To compare the therapeutic effects and complications of intravenous
versus local wound infiltration of using tramadol following pyelolithotomy.
METHODS: This double-blind study was carried out on 60 patients (age 18–60 y)
of American Society of Anesthesiologists physical status I–II who were awaiting
pyelolithotomy in Sina Hospital, Tehran, Iran, during 2006 and 2007. They were
randomly assigned to receive intravenous or subcutaneous wound infiltration with
tramadol. Vital signs, the intensity of pain (visual analog scale), and the level of
consciousness (Ramsey Sedation Scale [RSS]), as well as the frequency of
nausea and vomiting were recorded during 30 minutes to 1 hour after the patient
entered the recovery room. Vital signs were also recorded every hour until 6
hours postoperatively and then on the day after the patient was transferred to the
ward.
RESULTS: The RSS was lower in patients who had received subcutaneous
infiltration of tramadol (p < 0.001). A significant difference was noted in the
severity of pain between the groups; it was higher in the group that received
intravenous tramadol. The average time for the first meperidine requirement was
45.2 ± 8.4 min (mean ± SD) in the subcutaneous group and 21.6 ± 12.4 min in
the intravenous group. Total meperidine consumption was lower in patients who
had received subcutaneous wound infiltration with tramadol compared with those
who had received intravenous tramadol (p < 0.001). Nausea and vomiting were
more frequent during the first hour of recovery; the complication, however, was
less frequent in the subcutaneous group.
CONCLUSIONS: Subcutaneous wound infiltration with tramadol reduces post-
operative opioid consumption and produces less nausea and vomiting than does
intravenous administration.
KEY WORDS: meperidine, postoperative analgesia, tramadol, wound infiltration.
Ann Pharmacother 2009;43:xxxx.
Published Online, 3 Mar 2009, www.theannals.com, DOI 10.1345/aph.1L494

2. of this study was to compare the therapeutic effects and
possible complications of intravenous versus local wound
infiltration of tramadol following pyelolithotomy.
Methods
Following the approval of the institutional ethics com-
mittee, a double-blind randomized clinical trial was carried
out in the urology unit of Sina Hospital. Informed consent
was obtained from the patients. All 18- to 60-year-old pa-
tients of the American Society of Anesthesiologists physi-
cal status I–II who underwent pyelolithotomy during 2006
and 2007 were enrolled in the study. A pyelolithotomy is
an operation in which renal stones are extracted via a 15-
cm incision in the flank. Patients with definite liver disease
(eg, acute and chronic hepatitis, cirrhosis, hemochromato-
sis); renal impairment (acute and chronic renal failure,
glomerulonephritis); history of opium addiction and aller-
gy to tramadol; history of seizure disorder; or administra-
tion of monoamine oxidase inhibitors, naloxone, yohim-
bine, cimetidine, carbamazepine, and ondansetron were
excluded.
Midazolam 0.04 mg/kg and fentanyl 2 µg/kg were used
as premedication for all patients. Anesthesia induction was
achieved using atracurium 0.5 mg/kg, thiopental sodium 5
mg/kg, and lidocaine 1.5 mg/kg. Isoflurane with 1 mini-
mum alveolar concentration and O2/N2O 50% was main-
tained during the anesthesia period. After acceptable anes-
thesia was achieved, a Foley catheter was inserted.
Patients were placed in a flank position during surgery.
Bispectral index was maintained between 40 and 50. Until
30 minutes before the termination of the operation, fen-
tanyl 0.7 µg/kg was injected in patients who experienced a
20% increase in blood pressure or heart rate (compared
with baseline values measured in the ward). Patients who
required higher doses of opioids were excluded from the
study.
Isoflurane was discontinued and N2O was increased to
70% at the end of the surgery and at the time of suturing.
At this time, the patients were randomly assigned to 1 of 2
groups, using a computer random number generator: 1
group consisted of patients who received subcutaneous
wound infiltration with tramadol, and intravenous tra-
madol 2 mg/kg was prescribed for the other group. The
content of a microset filled with tramadol 2 mg/kg (mini-
mum dose 100 mg) plus NaCl 0.9% to a volume of 50 mL
was infused slowly in the intravenous group within 20
minutes. Subcutaneous wound infiltration contained tra-
madol 2 mg/kg titrated with NaCl 0.9% based on the pa-
tient’s weight for a total of 20 mL. Intravenous administra-
tion and subcutaneous wound infiltration with tramadol
were performed by the anesthesiologist and the surgeon,
respectively. Train of Four (TOF) was assessed with a
nerve stimulator at the end of the operation by a resident
unaware of the study objectives; N2O was discontinued
and O2 100% was administered if TOF was documented to
be 3 or 4. Muscular relaxation was reversed by neostig-
mine 50 µg/kg and atropine 20 µg/kg. The patients’ vital
signs, including blood pressure and heart rate, were moni-
tored at the time of injection.
Vital signs, the intensity of pain as measured by a 10-
mm visual analog scale (VAS), the level of consciousness
as measured by Ramsey Sedation Scale (RSS), and com-
plications such as nausea and vomiting were recorded by a
resident of anesthesiology, unaware of the type of drug ad-
ministered to each patient, 30 and 60 minutes after the pa-
tient had entered the recovery room.
Patients were transferred to the ward if there were no
signs of complication. Vital signs, pain, nausea, and vomit-
ing were recorded every hour until 6 hours postoperatively
and then on the day after they entered the ward. Meperi-
dine 0.5 mg/kg was administered intravenously if pain in-
tensity was greater than 4 and intravenous metoclopramide
10 mg/dose was prescribed if nausea and vomiting were
present.
STATISTICAL ANALYSIS
Based on a pilot study, the difference between the mean
VAS and the mean RSS of the 2 groups was calculated
(2.7 ± 3.8 vs 3.2 ± 1.3) and, considering the findings, the
required sample size for each group was calculated to be
30. For data analysis, we used independent sample t-tests,
Fisher’s exact test, and repeated measures analysis of vari-
ance with post hoc tests in SPSS software V. 15.
Results
The 60 patients enrolled in the study were divided into 2
groups. There were no significant differences in the demo-
graphic data of the participants (Table 1). Hemodynamic
changes (mean arterial pressure, heart rate) during the
study period are listed in Table 2. The mean differences in
RSS, VAS, and meperidine consumption in each group
I The Annals of Pharmacotherapy I 2009 March, Volume 43 www.theannals.com
MR Khajavi et al.
Table 1. Patient Characteristicsa
Characteristic Subcutaneous Intravenous p Value
Age (y) 35 ± 2.4 33.8 ± 4.1 0.65b
Male/female 17/13 13/17 0.439c
MAP 122.44 ± 2.5 124.21 ± 1.9 0.170b
HR 71.09 ± 3.27 68.66 ± 2.71 0.431b
Operation time (min) 120 ± 15 110 ± 25 0.284b
HR = heart rate; MAP = mean arterial pressure.
a
Mean ± SD.
b
Independent sample t-test.
c
Fisher’s exact test.

3. Tramadol Wound Infiltration
The Annals of Pharmacotherapy I 2009 March, Volume 43 Iwww.theannals.com
Table 3. VAS, RSS, and Meperidine Use
p Value
Mean 95% CI of (repeated
Subcutaneous Intravenous Difference Mean measures
Parameter (mean ± SD) (mean ± SD) p Valuea
± SD Difference ANOVA)
VAS
30 min 2.2 ± 0.9 2.4 ± 1.7 0.702 0.1 ± 0.3 –0.6 to 0.8
1 h 2.4 ± 1.7 3.1 ± 1.7 0.117 0.7 ± 0.4 –1.6 to 0.2
2 h 1.7 ± 0.9 3.6 ± 2.3 <0.001 1.9 ± 0.4 –2.8 to –0.9
3 h 2.3 ± 1.2 4.1 ± 2.2 <0.001 1.8 ± 0.5 –2.7 to –0.8 <0.001b
4 h 2.7 ± 1.3 3.7 ± 2.1 0.028 1.0 ± 0.5 –1.9 to –0.1
5 h 2.8 ± 1.3 3.5 ± 2.3 0.137 0.7 ± 0.5 –1.7 to 0.2
6 h 2.9 ± 1.6 3.6 ± 1.9 0.119 0.7 ± 0.5 –1.7 to 0.2
24 h 2.4 ± 0.8 2.7 ± 0.8 0.080 0.3 ± 0.2 –0.8 to 0.1
RSS
30 min 2.7 ± 0.8 3.9 ± 1.1 <0.001 1.2 ± 0.2 –1.7 to –0.7 <0.001c
60 min 1.9 ± 0.6 1.9 ± 0.8 0.848 0.3 ± 0.2 –0.4 to 0.3
Meperidine use
1 h 8.3 ± 14.3 13.6 ± 17.4 0.198 5.4 ± 4.1 –13.6 to 2.9
2 h 1.2 ± 6.4 13.6 ± 18.6 0.001 12.5 ± 3.6 –19.6 to –5.2
3 h 5.3 ± 14.2 19.0 ± 18.8 0.002 13.7 ± 4.3 –22.3 to –5.0 <0.001d
4 h 5.2 ± 11.9 15.9 ± 18.9 0.011 10.7 ± 4.1 –18.9 to –2.5
5 h 10.2 ± 17.6 13.3 ± 17.1 0.491 3.1 ± 4.5 –12.0 to 5.8
6 h 6.4 ± 11.9 13.5 ± 18.4 0.081 7.1 ± 4.0 –15.1 to 0.9
24 h 0 6.6 ± 15.2 0.024 6.6 ± 2.8 –12.3 to –0.9
ANOVA = analysis of variance; RSS = Ramsey Sedation Scale; VAS = visual analog scale.
a
Independent sample t-test.
b
Comparison of the changes in the VAS scores during the study period using repeated measure.
c
Comparison of the changes in the RSS scores during the study period using repeated measure.
d
Comparison of the changes in the amount of meperidine consumption during the study period using repeated measure.
Table 2. MAP and HR During the Study
p Value
Mean 95% CI of (repeated
Subcutaneous Intravenous Difference Mean measures
Parameter (mean ± SD) (mean ± SD) p Valuea
± SD Difference ANOVA)
MAP
30 min 129.3 ± 15.3 127.3 ± 12.6 0.571 2.1 ± 3.6 –9.3 to 5.2
1 h 123.9 ± 10.3 124.4 ± 9.4 0.845 0.5 ± 2.5 –4.6 to 5.6
2 h 125.0 ± 14.3 122.0 ± 9.2 0.338 3.0 ± 3.1 –9.2 to 3.2
3 h 124.7 ± 13.5 122.8 ± 9.7 0.535 1.9 ± 3.0 –7.9 to 4.2 0.027b
4 h 122.5 ± 13.7 122.2 ± 9.1 0.929 0.3 ± 3.0 –6.3 to 5.7
5 h 122.6 ± 13.7 121.4 ± 10.1 0.510 2.4 ± 3.6 –9.5 to 4.8
6 h 125.8 ± 14.0 122.1 ± 10.0 0.237 3.8 ± 3.1 –10.1 to 2.5
24 h 125.1 ± 9.5 123.3 ± 8.1 0.416 1.9 ± 2.3 –6.4 to 2.7
HR
30 min 83.5 ± 15.2 77.4 ± 11.7 0.087 6.1 ± 3.5 –13.1 to 0.9
1 h 81.1 ± 8.4 76.0 ± 8.7 0.026 4.6 ± 2.9 –10.5 to 1.2
2 h 78.2 ± 10.6 72.0 ± 8.8 0.017 6.2 ± 2.5 –11.2 to –1.2
3 h 81.9 ± 13.1 75.7 ± 9.0 0.036 6.2 ± 2.9 –12.0 to –0.4 0.017c
4 h 78.4 ± 11.9 75.8 ± 10.6 0.364 2.7 ± 2.9 –8.5 to 3.2
5 h 78.8 ± 10.5 74.7 ± 10.6 0.146 4.0 ± 2.7 –9.5 to 1.4
6 h 79.0 ± 12.1 77.5 ± 10.4 0.6 1.5 ± 2.9 –7.4 to 4.3
24 h 77.4 ± 8.2 75.1 ± 8.1 0.285 2.3 ± 2.1 –6.5 to –1.9
ANOVA = analysis of variance; HR = heart rate; MAP = mean arterial pressure.
a
Independent sample t-test.
b
Comparison of the changes in the MAP values during the study period using repeated measure.
c
Comparison of the changes in the HR values during the study period using repeated measure.

4. during the study period are outlined in Table 3. RSS was
reported to be lower in the group that received subcuta-
neous versus intravenous wound infiltration with tramadol
(2.7 ± 0.8 vs 3.9 ± 1.1, respectively); a significant differ-
ence was found between the 2 groups within the first 30
minutes (p = 0.006).
The VAS score in the first 30 minutes following the op-
eration was 2.2 ± 0.9 in the subcutaneous group and 2.4 ±
1.7 in the intravenous group. The VAS score was reported
to be higher in the group that received intravenous tra-
madol throughout the study (Figure 1). These scores were
found to be significant at 2 (p < 0.001), 3 (p < 0001), and 4
(p = 0.028) hours.
The average time for the first meperidine requirement
was 45.2 ± 8.4 minutes in the subcutaneous group and 21.6
± 12.4 minutes in the intravenous group (p < 0.001). Total
meperidine consumption was lower in the group that re-
ceived subcutaneous wound infiltration with tramadol.
This difference was statistically significant in the fourth
hour and a day following the operation (4 h 5.2 ± 11.9 mg
[subcutaneous] vs 15.9 ± 18.9 mg [intravenous]; 24 h [sub-
cutaneous] vs 6.6 ± 15.2 mg [intravenous]).
Considering both groups, nausea and vomiting were fre-
quently reported during the first hours of recovery
(31.7%); the complication, however, was less frequent 6
hours after the operation (Table 4). Nausea and vomiting
occurred less frequently in the subcutaneous group
throughout the study period. None of the subjects com-
plained about peri-incisional allodynia or hyperalgesia dur-
ing the study period.
Discussion
Opioids have long been the mainstay for postoperative
pain relief; however, the high rates of adverse effects pro-
vide an impetus to investigate alternatives. Recent studies
have shown that localized use of these drugs can overcome
the associated problems.6-8
Many studies have shown that the peripheral local anes-
thetic effects of tramadol are related to those of codeine.2,9,10
According to these studies, the suggested sites of action for
this drug are the nerve endings as well as a possible associat-
ed central effect. In this study, we demonstrated that subcu-
taneous wound infiltration with tramadol following
pyelolithotomy is associated with a lower incidence of
nausea and vomiting, reduced need for meperidine, de-
crease in VAS scores, and lower RSS level.
There was no significant difference between the final
mean arterial pressure and heart rate of the 2 groups; this
could be due to complete absorption of tramadol after it is
infiltrated into the wound, along with good pain control in
the 2 groups. However, a significant change in mean arteri-
al pressure was reported over time in each group; this was
not related to the method by which tramadol was adminis-
I The Annals of Pharmacotherapy I 2009 March, Volume 43 www.theannals.com
MR Khajavi et al.
Figure 1. Mean pain severity (VAS) in each group (repeated measures analysis with comparing factor, p < 0.001). IV = intravenous administration;
SC = subcutaneous wound infiltration; VAS = visual analog scale.

5. tered. These findings were similar to the results of the
study conducted by Pang et al.6
In that study, they showed
that there was no significant difference in arterial blood
pressure, heart rate, and respiratory depression following
intramuscular and intravenous injection of the analgesic.
Several studies have noted that use of analgesic agents
such as tramadol during surgery lowers a patient’s postop-
erative need for morphine. Unlugenc et al.11
found a con-
siderable decrease in morphine consumption following tra-
madol administration after major abdominal surgery. Al-
tunkaya et al.12
showed that the duration of postoperative
analgesia provided by subcutaneous wound infiltration
with tramadol was significantly longer compared with the
length achieved with lidocaine. Similarly, in our study,
there was a significant decrease in the postoperative de-
mand for analgesia in the group that received subcuta-
neous wound infiltration with tramadol. This fact demon-
strates the higher effectiveness of subcutaneous wound in-
filtration with tramadol, possibly due to its concurrent local
and systemic effects.
Immer et al.13
could not identify any significant differ-
ences in VAS, morphine consumption, or antiemetic re-
quirement following tramadol administration; this was
contrary to the findings of our study. Nausea and vomiting
are the major adverse effects of tramadol.14,15
The rate of
titration of the tramadol dose, rather than the target dose, is
the major determinant of a patient’s tolerability; therefore,
our patients experienced less nausea and vomiting when
receiving tramadol via subcutaneous wound infiltration.16
Yet, there is no report of such complications following
subcutaneous wound infiltration with tramadol.6
Another
study demonstrated skin rash due to histamine release after
tramadol injection17
; however, such a complication was ab-
sent in our study.
Similar to other studies, our study concluded that intra-
venous administration of tramadol is accompanied by
more complications, as well as a longer recovery time
(higher RSS), compared with localized subcutaneous infil-
tration.18
We did not evaluate the link between tramadol’s blood
concentrations and the resulting analgesic effects. We rec-
ommend that the serum concentration of tramadol and the
key pharmacokinetic parameters be determined to estab-
lish a dose–response relationship and the reliability for this
method of drug administration.
In conclusion, following subcutaneous wound infiltra-
tion with tramadol, postoperative analgesia was prolonged
and the need for more opioid was reduced considerably.
However, administration of tramadol at the operation site
requires further studies.
Mohammad Reza Khajavi MD, Associate Professor of Anesthe-
siology, Tehran University of Medical Sciences, Sina Hospital, Tehran,
Iran
Seyed Babak Mojaver Aghili MD, Resident of Anesthesiology,
Tehran University of Medical Sciences, Sina Hospital
Reza Shariat Moharari MD, Assistant Professor of Anesthesiology,
Tehran University of Medical Sciences, Sina Hospital
Atabak Najafi MD, Associate Professor of Anesthesiology, Tehran
University of Medical Sciences, Sina Hospital
Robab Mohtaram MD, Assistant Professor of Anesthesiology,
Tehran University of Medical Sciences, Farabi Hospital, Tehran, Sina
Hospital
Patricia Khashayar MD, General Practitioner, Research and De-
velopment Center, Tehran University of Medical Sciences, Sina Hos-
pital
Mojtaba Mojtahedzade PharmD, Professor of Pharmacotherapy,
Tehran University of Medical Sciences, Sina Hospital
Reprints: Dr. Reza Shariat Moharari, Tehran University of Medical
Sciences, Sina Hospital, Hassan Abad Square, Tehran, Iran, fax 98-
2188276654, moharari@sina.tums.ac.ir, naeem.moharari@
gmail.com
We are indebted to the Research and Development Center of Sina Hospital for their
support. We acknowledge Gazelle Shariat Moharari, biology student, for her review
and helpful comments on this article. We also thank Mohsen Rezaii MD for his sup-
port and comments regarding the statistics of the study.
References
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thetic effects of tramadol with prilocaine for minor surgical procedures.
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3. Desmeules JA, Piguet V, Collart L, Dayer P. Contribution of monoamin-
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4. Mert T, Gunes Y, Guven M, Gunay I, Ozcengiz D. Comparison of nerve
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Tramadol Wound Infiltration
The Annals of Pharmacotherapy I 2009 March, Volume 43 Iwww.theannals.com
Table 4. Frequency of Nausea and Vomiting in
Each Group During the Study
Subcutaneous Intravenous
Time (%) (%) p Valuea
p Valueb
30 min 1 (3.3) 10 (33.3) 0.006
1 h 3 (10) 16 (53.3) <0.001
2 h 0 13 (43.3) <0.001
3 h 2 (6.7) 12 (40) 0.002 <0.001c
4 h 1 (3.3) 9 (30) <0.001
5 h 0 8 (26.7) 0.002
6 h 2 (6.7) 6 (20) 0.254
a
Fisher’s exact test
b
Repeated measure analysis of variance.
c
Comparison of the incidence of nausea and vomiting during the study
period using repeated measure.

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tramadol, metoclopramide and lidocaine following intradermal injection.
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prolongs the duration of an axillary brachial plexus blockade. Anesth
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madol compared with morphine after major abdominal surgery. Br J
Anaesth 2003;91:209-13.
12. Altunkaya H, Ozer Y, Kargi E, et al. The postoperative analgesic effect
of tramadol when used as subcutaneous local anesthetic. Anesth Analg
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La Infiltración Subcutánea de Tramadol en el Lugar de la Herida en
Comparación con la Administración Intravenosa Después de una
Pielolitotomía
MR Khajavi, SBM Aghili, RS Moharari, A Najafi, R Mohtaram, P
Khashayar, y M Mojtahedzade
Ann Pharmacother 2009;43:xxxx.
EXTRACTO
TRASFONDO: Recientemente, el efecto anestésico periférico del tramadol
ha sido el tema de muchos estudios. Los efectos analgésicos postoperatori-
os de la infiltración subcutánea del tramadol en la herida no han sido
ampliamente estudiados ni comparados con los de la administración
intravenosa.
OBJETIVOS: El propósito de este estudio fue comparar los efectos terapéuti-
cos y las complicaciones de la administración intravenosa en comparación
con la infiltración local en la herida al usar el tramadol después de una
pielolitotomía.
MÉTODOS: Este estudio doble ciego fue llevado a cabo en 60 pacientes, con
un estado físico I-II según la ASA en un grupo de edad de 18 a 60 años
en espera de una pielolitotomía en el Hospital de Sina durante 2006 y
2007. Los pacientes fueron asignados al azar a recibir tramadol
intravenoso o mediante infiltración subcutánea en la herida.
Se registraron los signos vitales, la intensidad del dolor (VAS) y el nivel
de consciencia (Escala de Sedación de Ramsey [RSS]) al igual que la
frecuencia de las náuseas y los vómitos durante 30 minutos a una hora
después de que el paciente entrara a la sala de recuperación. También, se
registraron cada hora durante 6 horas y luego el día después de entrar a
la habitación.
RESULTADOS: La RSS fue menor en los que habían recibido la infiltración
subcutánea de tramadol (p < 0.001). Se observó una diferencia significativa
en cuanto a la severidad del dolor entre los grupos. Ésta fue mayor en el
grupo que recibió el tramadol intravenoso. El tiempo promedio para
requerir la primera dosis de la meperidina fue 45.2 ± 8.4 minutos en el
grupo SC y 21.6 ± 12.4 minutos en el grupo IV. El uso total de la
meperidina fue menor en el grupo que había recibido la infiltración
subcutánea de tramadol en la herida en comparación con los que habían
recibido el tramadol intravenoso (p < 0.001). La náusea y el vómito fueron
más frecuentes durante la primera hora de la recuperación; sin embargo,
la complicación fue menos frecuente en el grupo SC.
CONCLUSIONES: La infiltración subcutánea de tramadol en la herida reduce
el uso postoperatorio de opiodes y se produce menos náusea y vómito
que con el uso IV.
Traducido por Rafaela Mena
I The Annals of Pharmacotherapy I 2009 March, Volume 43 www.theannals.com
MR Khajavi et al.