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Efficacy and Safety of Transdermal Fentanyl Patches on Postoperative Pain Relief after Major Abdominal
Surgery
Samy A. Amr, Mostafa G. Mostafa, and Mohamed A.M. Mostafa
Department of Anesthesia, ICU & Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.
[email protected]
Abstract: A double blind study was carried out on 100 adult ASA grade I/II patients to evaluate efficacy and safety
of transdermal fentanyl for postoperative pain relief. Patients were randomly divided into 2 groups, group I (n=50)
each patient received transdermal therapeutic system-fentanyl 50g/h [TDF group], and group II (n=50) each patient
received transdermal placebo patch [C group ]. All patches were placed 10 hours preoperatively and covered with
adhesive plaster to confirm fixation and to blind the anesthetists and observers for the type of the used patches.
Surgery were done under general anesthesia and i.v. morphine were given once patients start to first experienced
pain postoperatively. The two groups did not differ significantly as regard age, weights, sex, duration of surgery or
anesthesia and hemodynamic parameters throughout the period of the study (48 hours). Pain intensity was lower in
TDF group than C group in the immediate postoperative period and at 12th to 48th hours. Percentage of patients with
normal postoperative O2 saturation were higher in TDF group than C group (P<0.000), in both groups no patient
suffered from severe hypoxia ( O2 saturation < 90%). First time of i.v. morphine administration was short in C
group as compared to TDF group, (0.70.3hour Vs 1.75.8hour, P=0.003). Frequency and total morphine
consumption were significantly higher in C group than TDF group (P<0.000). Intraoperative fentanyl consumption
was also higher in C group (250.335.7) as compared with TDF group (118.219.1). Nausea and vomiting were
lower in TDF group (32%) than C group (62%),( P<0.05), and no other side effects were observed in the two
groups. Conclusion: Transdermal fentanyl patch 50g/h is an effective non invasive and can be used safely for
postoperative pain relief in major abdominal surgery with minimal acceptable side effects.
[Samy A. Amr, Mostafa G. Mostafa, And Mohamed A.M. Mostafa. Efficacy and Safety of Transdermal Fentanyl
Patches on Postoperative Pain Relief After Major Abdominal Surgery. J Am Sci 2012;8(6):417-424]. (ISSN:
1545-1003). http://www.americanscience.org. 52
Key words: Transdermal fentanyl, Postoperative pain, Major surgery.
pain, and it has been demonstrated that transdermal
fentanyl provides effective analgesia for acute
postoperative pain [6].
The use of continuous opioid administration
versus PCA in managing postoperative pain is
dependent on a variety of factors, and may be
especially useful in subsets of patients who cannot
use PCA, such as elderly, disoriented, or handicapped
patients. Also when comparing the TDF with the
PCA it has several advantages: first, it costs less than
PCA, because PCA is expensive, it may not be
available to every patient; therefore, TDF could be an
interesting alternative. Moreover, TDF does not
require i.v. access. The risk of infection is decreased,
and the patient's comfort improved. In addition, TDF
does not need to be programmed, so avoiding
program errors that occur with PCA. At the same
time the skin is an organic system with a large
surface area and its use as a route of drug
administration should be considered when evaluating
patients, particularly if they meet any of the above
criteria [6].
The early transdermal administration of
fentanyl was achieved via a reservoir patch [7].
However, this patch was associated with significant

1. Introduction:
Although control of postoperative pain is
important for recovery, clinical surveys continue to
show that many patients experienced moderate to
severe degrees of pain following surgery [1].
McCaffery and Ferrell showed that over 50% of
surgical patients experienced inadequate pain relief
following surgery with negative physiological and
psychological consequences [2].
In recent years, increased interest in the
treatment of acute and chronic pain has resulted in
the development of transdermal delivery systems for
analgesia. Transdermal drug delivery offers the
potential benefits of simplicity, efficacy, and patient
acceptance. In theory, a transdermal delivery system
can provide a stable serum concentration for an
extended period of time with acceptable interpatients
variability. The physicochemical and physiological
principles governing transdermal drug absorption
have previously been describe [3,4]. Administration
of fentanyl by the transdermal route is appealing
because fentanyl is a potent agent with well-defined
clinical
pharmacological
characteristics
[5].
Transdermal delivery system for fentanyl has been
developed and approved for the treatment of chronic

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interindividual variability, so fentanyl matrix patch

was developed and designed to be bioequivalent to
the original reservoir patch with a constant and
reliable fentanyl release. However, comparing it with
the reservoir patch, the fentanyl in the matrix patch is
entirely dissolved in the adhesive, thus opioid
dissolution is not required prior to its diffusion
through the matrix following application [7]. The
matrix patch also has better flexibility and skin
conformability, and produce linear fentanyl dose
kinetics with negligible dose loading [7,8].
Taylor and Stanbury [9] have been
suggested that the way for improving postoperative
pain management should includes procedure specific
guidelines, new methods to predict postoperative pain
and new drugs and delivery systems. So our aim in
this study was to evaluate the effectiveness and safety
of transdermal fentanyl patches for relieving
postoperative pain after major abdominal surgery
under general anesthesia.

In both groups general anesthesia was

induced using lidocaine (1.5mg/kg), propofol (1-2
mg/kg), cisatracurium (0.15 mg/kg) to facilitate
intubation and small dose of fentanyl (1g/kg to
avoid stress of intubation) and maintained using
inhalational anesthetic (sevoflurane 2-3%) and
muscle relaxant (cisatracurium 0.03mg/kg) with
mechanical ventilation at rate of 10 breaths/minute
and tidal volume of 10ml/kg with oxygen flow of 2
liters/minute. Increments of fentanyl were allowed
until 30 minutes prior to skin closure to maintain
cardiovascular status (HR and BP) at 20% around the
preoperative status.
At the end of operation residual muscle
relaxation was reversed using neostigmine
(0.05mg/kg) and atropine [0.02mg/kg (0.2mg for
each 0.5mg of neostigmine)]. Intraoperative
monitoring included ECG, pulse oximetry, NIBP,
ETCO2 and invasive blood pressure (if needed for the
operation). In the recovery room, if patients of the
studied groups were awake, breath spontaneously and
be able to answer questions and follow command
were shifted to PACU for observation and follow up
for at least 48 hours (the period of the study). Any
patient with surgical problems and needs any surgical
interference after recovery or who unable to
communicate postoperatively were excluded from the
study.
In our study we used fentanyl patches
[Durogesic D-Trans (matrix) from Janssen-Cilag]
with delivery rate of 50g/h patch. Either fentanyl
patches or placebo patches were placed on a hair-free
area (the antero-lateral chest wall) and mounted in
place and covered by adhesive plaster. The area was
not shaved to maintain the integrity of the skin to
maintain normal absorption (if necessary hair was
only clipped from the patch site prior to application).
The patch was removed 48 hours postoperatively.
The patients were told that the patch would relieve
their postoperative pain. All patients were monitored
during the preoperative period for complications such
as nausea, vomiting, respiratory depression,
hemodynamic instability and sedation.
As soon as patients were oriented and when
patients first experienced pain or in case of
insufficient analgesia (pain score > 3) the patients
were administered intermittent doses of i.v. morphine
(5-10 mg) through the subsequent 90 minutes period
and until the end of the study period (48 hours).

2.Patients and Methods:

After Hospital Ethics Committee approval, the
study was conducted on 100 patients after obtaining
their written informed consent, their age were
between 20-60 years, ASA I/II with body weight
ranged between 65kg and 100 kg. They were
scheduled to undergo major pelvi-abdominal cancer
surgery under general anesthesia. This study was
carried out in South Egypt Cancer Institute from
October 2009 to August 2011. We exclude, patients
received
preoperative
opioids,
having
contraindication to regional block (coagulation
defect, local infection at the site of injection or
patient refusal), patients having moderate or severe
renal and hepatic impairment, patients with
documented history of opioid sensitivity or drug
abuse.
All patients were randomly allocated to one
of the following groups: Group I, Patients were
received Transdermal Therapeutic System-Fentanyl
(TDF group, n=50) 50 g / h patch, placed 10 hours
preoperatively and Group II, Patients were received
transdermal placebo patch, placed 10 hours
preoperatively (C group, n=50 ).
Before any patch placement a preoperative
visit was done to all patients to assess patient fitness
for operation, to alleviate anxiety and to make them
familiarized with the VAS. Patients also were
informed about transdermal patches (its efficacy in
the treatment of postoperative pain and its possible
side effects) and they informed about method of
application. The patients were also assured that they
would receive i.v. morphine once they start to first
experienced pain postoperatively.

Monitoring and assessment:

Each patient in both groups were followed
up immediately postoperative for 90 minutes and
every four hours for 48 hours postoperatively and
were monitored for, the hemodynamic parameters (
heart rate, ECG and noninvasive blood pressure),

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respiratory pattern in the form of respiratory rate,

oxygen saturation (using pulse oximetry) and end
tidal CO2. The duration of analgesia, as indicated by
the onset of pain, pain intensity score by using the
VAS, (which is a line graded from 0-10, where 0 =
no pain and 10 = the worst pain imaginable) was
performed in the immediate postoperative period and
at 30, 60 and 90 minutes then every 4 hours for 48
hours. [Patients who had pain score > 3 received an
additional dose of intravenous morphine (5-10 mg)].
Also side effects of opioids such as nausea and
vomiting, itching. respiratory depression, and
erythema were recorded. Sedation by Ramsay
sedation score (1-5) where: 1 = Awake, 2 = drowsy, 3
= Sleepy but rousable to mild stimulation, 4 = Sleepy
but rousable to strong stimulation, 5 = Unconscious
patient not answering to contact, were also recorded.
The doses of fentanyl consumed during the
operation, first time of requesting analgesia,
frequency of morphine administration and the total
dose of morphine consumed by the patient during the
period of the study were recorded in all groups.
Medical management of respiratory depression
consisted of removal of the offended drug (removal
of the patch) and administration of i.v. incremental
doses of naloxone (80-100 g) according to patient
response. All the observations were done and
recorded by another anesthetist not involved or
unaware for patients group assignment.
Statistical analysis:
Data were analyzed by using SPSS version
15 (Chicago, USA). Data were expressed as mean
SD or number (%). Age, weight, duration of surgery
or anesthesia and analgesic consumption compared
using unpaired t-test. Percentage and frequencies of
patients compared using Chi-square. Repeated
measures ANOVA was used to compare the other
variables. A P-value 0.05 was considered
statistically significant.

and group C respectively had score between 3-5cm

(P < 0.001), and 62 % and 25% of patients in group
TDF and group C respectively had score less than
3cm (P < 0.001), table (2).
Pain assessment was done throughout the
period of the study (48 hours) by using VAS score.
When comparing the two groups together at the same
time (by using ANOVA test), it was found that the
VAS was significantly lower in the TDF group
during the immediate postoperative period and from
the 12th to the 48th hour as compared with the C
group (P0.001). But from the 4th to 8th hour, there
was no significant difference between the two groups,
Fig I.
Table (1): Patient characteristics, duration of
surgery and anesthesia.

Sex: No. (%)

Male
Female
Age: (years)
Mean SD
Weight: (kg)
Mean SD
Duration of surgery
(min)
Duration
of
anesthesia (min)

TDF group
(n= 50)

C group
(n= 50)

23 (46%)
27 (54%)

24 (48%)
26 (52%)

46.9 8.1

48.5 10.0

74.3 7.6
185.6 25.4

76.8 6.1
182.5 27.8

212.5 30.4

215.8 32.6

Table (2): Distribution of pain intensity

the first 90 minutes.
Pain score
TDF
C
62 %
25%
< 3 cm
24%
35%
3-5 cm
14 %
25%
5-7 cm
0.0%
15%
> 7 cm
*P : TDF versus C

3. Results
Fifty patients in each group completed the
study with no significant differences between the two
groups with respect to demographic variables (age,
sex, body weight). Duration of surgery and anesthesia
were also comparable between the two groups. There
were no patient withdrawals due to severe adverse
events, table (1).
Pain intensity score was compared by using
the VAS score in the first 90 minutes and it was
found that, there were no patients in the TDF group
showed pain score more than 7cm. But 15% of
patients in group C had score more than 7cm (P <
0.001). Also 14 % and 25% of patients in group TDF
and group C respectively had score between 5-7cm
(P < 0.001), 24% and 35% of patients in group TDF

Fig (I): VAS score.

419

score in
P value
0.000*
0.000*
0.000*
0.000*

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There were no statistically significant

differences between the two groups in the
hemodynamic parameters [systolic blood pressure
(SBP), diastolic blood pressure (DBP) and heart rate
(HR) throughout the period of the study.
The percentage of patients with normal
saturation on room air was significantly higher in
TDF group than in the C group (P < 0.001). Also the
percentage of patients with mild hypoxia was
significantly lower in the TDF group than in the C
group (P < 0.001). In both groups no patients
suffered from severe postoperative hypoxia (Table 3).
The first time of morphine administration in group C
was shorter than group TDF (P<0.01). There were
significant differences between the two groups as
regard to frequency of morphine administration, the
TDF group had a lower frequency of administration
of morphine as compared to C group (0.5 0.73 Vs
4.8 0.85 ) (P < 0.001).
In the TDF group patients consumed less
amount of morphine than the C group, 2.5 3.65 mg
Vs 29.00 4.23 mg. Also intraoperative fentanyl
consumption was higher in the C group as compared
to the TDF group (250.3 35.7 g Vs 118.2 19.1
g) ( P< 0.001), table (4).
The adverse effects were compared in the two
groups throughout the period of the study. It was
found that, there was statistically significant
difference in nausea & vomiting, the TDF group had
a lower incidence of nausea and vomiting (16 (32%)
cases) versus (31( 62%) cases) for the C group (P <
0.05). Nausea and vomiting were treated by giving
dexamethasone 8mg and metoclopromide 10 mg
intravenously.
.
There were no reported cases of itching or
respiratory depression in TDF group and C group.
There were also no reported cases of erythema at the
sites of patch application. The overall sedation score
was significantly higher in C group (2.461.9) as
compared to TDF group (1.450.6), table (5).

Table (4): Morphine and fentanyl consumption

(mean SD).
Group
TDF
C
P value
First time of
morphine
1.7 5.8 0.7 0.3
0.003*
administration
(h)
Frequency of
0.000*
0.5 0.73 4.8 0.85
morphine
administration.
Total dose of
29.00
morphine
2.5 3.65
0.000*
4.23
consumption
(mg)
Intraoperative
118.2
250.3
fentanyl
0.000*
19.1
35.7
consumption
(g)
*P: TDF versus C
Table (5): Adverse effects.
P
value
1.000

Adverse effects

TDF

Itching
Nausea and
vomiting
Erythema
Respiratory
depression
Sedation score
(meanSD)
*P: TDF versus C

0.0%
16(32
%)
0.0%

0.0%
31(62 %
)
0.0%

0.020*

0.0%

0.0%

1.000

1.450.6

2.461.9

0.000*

1.000

4. Discussion
Central sensitization and hyper excitability
develop after the surgical incision and result in
amplification of postoperative pain. Preventing the
establishment of altered central processing by
analgesic treatment may result in short-term (e.g.,
reduction in postoperative pain and accelerated
recovery) and long-term (e.g., reduction in chronic
pain and improvement in health related quality of
life) benefits during a patient's convalescence [10].
Our choice of TDF for postoperative
analgesia was to give the patient a source of
continuous analgesia so that his need for additional
analgesia and nursing are decreased. This is because
some studies of nursing behavior, concluded that
nurses tended to doubt what patients say about their
pain, often do not ask about pain and overestimate the
percentage of patients who over-report their pain.
Also another studies were, cleared that nurses do not
always administer all available analgesia despite
patients being in pain [11-15].

Table (3): Percentage of patients with normal

saturation, mild hypoxia and severe hypoxia
(during 48 hours).
Oxygen
TDF
C
P value
saturation
87 %
80.0%
0.000*
Normal
saturation (95%100%)
12 %
20.0%
0.000*
Mild hypoxia
(90%-94%)
0.0%
0.0%
1.000
Severe hypoxia
(<90%)
*P : TDF versus C

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The first clinical trials on transdermal

fentanyl were performed in patients with acute
postoperative pain to prove its analgesic effectiveness
in an established pain model and provide data about
required dosages, serum concentrations and safety. In
most studies, a patch with a delivery rate of 50, 75 or
100g/h was administered 1 to 8 hours before surgery
and removed after 24 or 72 hours. All patients had
free access to a rescue medication if pain was not
adequately relieved [16].
There were several case reports in which the
TDF was used for the management of acute pain and
resulted in fatal complications. Some of these cases
include, one patient 19-year-old woman with acute
abdominal pain, TDF was started with a dose of 100
g/h, she died at home from respiratory depression
[17].
Another case was reported by Flannagan et
al. [18] in which a 31-years old man died from
fentanyl poisoning after he apparently obtained
fentanyl from a used patch removed from a diseased
patient. The man had no other known access to this
drug. The exact route of administration (e.g. injection
or transmucosal administration of patch content) was
not known. Another case reported by Hardwick et al.
[19], in which a 17-year-old male treated with TDF
after a wisdom tooth extraction was found dead after
going to sleep on a heated waterbed.
Another case reported by Edinboro et al.
[20], in which an 83- year-old female with terminal
cancer was found dead with three 100g/h fentanyl
patches; death was caused by fentanyl overdose, but
it was not established if this was an accidental
overdose, a suicide or possibly a homicide. Another
case reported, in which a 31-year-old man died from
fentanyl overdose via mucous membrane absorption.
At intubation, a fentanyl patch (75g/h) was removed
from the buccal cavity, but it was documented that
patients to whom the TDF was applied require
monitoring like other parentral routes for opioid
administration [21,22].
Our study demonstrated that continuous
opioid administration using transdermal delivery of
fentanyl with a predicted nominal delivery rate of
50ug/hour achieves effective and safe postoperative
analgesia in patients undergoing pelvi-abdominal
oncologic surgery. This is in contrast to what was
reported previously in which continuous opioid
infusions (via transdermal fentanyl) plus PCA
resulted in increased side effects with no increase in
analgesia versus PCA alone [23,24]. Also Sevarino et
al, have been questioned the utility of transdermal
fentanyl in combination with i.v. morphine for
postoperative orthopedic pain [25].
Hug[26], was reported that although the
therapeutic range for serum fentanyl concentration

has been reported as 13ng/ml, there is wide

interpatients
variability,
resulting
from
pharmacokinetic,
pharmacodynamic
and
psychological factors.
Our choice of the transdermal delivery
system of fentanyl with a predicted delivery rate of
50g/hour was based on a previous study
characterizing the relationship between serum
fentanyl concentrations and analgesic effects in
patients undergoing abdominal surgery. Some studies
demonstrated a non significant reduction in opioid
requirements using delivery rates of 25g/h [27-29].
On the other hand, up to 9% of patients were at risk
of respiratory depression when being treated with
TDF 75g/h (administered 8 hours prior to surgery)
[30]. For management of postoperative pain, it may
be desirable to apply transdermal fentanyl several
hours before completion of surgery so that MEC can
be achieved prior to or concomitant with the end of
surgery. Additionally, the slow decline in serum
fentanyl levels offers the potential advantage that the
transition to other forms of pain management can be
accomplished without an abrupt loss of analgesia.
However, if prompt and complete termination of
opioid effect is desired, serial injections of an opioid
antagonist such as naloxone may be required until the
skin depot is sufficiently depleted [6].
When serum fentanyl concentrations
reached a plateau approximately 14 hours after
placement of the transdermal fentanyl delivery
system, this plateau was maintained until removal of
the system at 48 hours [22,31].
In the present study, this pharmacokinetic
aspect of the TDF was taken into account, the TDF
patches were placed about 10 hours before the
surgery, so that the plateau was attained
approximately at the end of the surgery. Thus,
patients
emerged
from
general
anesthesia
comfortable and without pain, explaining the low
VAS score and morphine consumption in the
immediate post-operative period. This is similar to
the study previously done in which the TDF was
placed 10 hours before surgery [32].
There were several studies which did not
take the pharmacokinetics of TDF into account. Like
the studies of Rowbotham et al. [33] and Sevarino
et al. [25], which the TDF was placed only two
hours before surgery. Also in the study by Caplan et
al. [34], the TDF was placed just before surgery and
in the study by Gourlay et al. [35], the TDF was
placed during the surgery. In these studies the
analgesic effect was commonly less apparent during
the first 12 hours after application. The application
and removal of the transdermal system was
accompanied by slow changes in serum fentanyl
levels.

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Our study showed that there were

significantly lower VAS scores and morphine
consumption (including the frequency of morphine
administration) throughout the period of the study in
the TDF group.
Kilbride et al. [36] compared TDF (with
delivery rate of 50ug/h) applied six hours before
surgery and removed after 72 hours with placebo for
the management of post-hemorrhoidectomy pain.
They found that there were significant reduction in
the pain intensity and rescue analgesia in the TDF
group when compared with the placebo group.
Sevarino et al. [28] compared TDF in two
different delivery rates 25 ug/h and 50 ug/h with
placebo for postoperative analgesia after abdominal
gynecologic surgery (the patches were applied one
hour before surgery and removed after 72 hours).
They found that there were no differences in the pain
intensity in both TDF groups and no differences in
rescue analgesia in the TDF group with delivery rate
of 25ug/h when compared with the placebo group.
There was only a significant reduction in the rescue
analgesia in the TDF group with a delivery rate of
50ug/h.
Also Sandler et al. [37] compared TDF in
two different delivery rates 50 g/h and 75g/h with
placebo for postoperative analgesia after abdominal
hysterectomy (the patch was applied two hours
before surgery and removed after 72 hours). They
found that there were significant reduction in the pain
intensity and rescue analgesia in the TDF group with
delivery rate of 75g/h when compared with the
placebo group. But in the TDF group with delivery
rate of 50g/h there was only a significant reduction
in rescue analgesic consumption when compared with
the placebo group.
Transdermal fentanyl provided effective
analgesia for acute postoperative pain. The VAS pain
scores were consistently better in the fentanyl group
compared with the placebo group, and these lower
pain scores were strongly correlated with serum
fentanyl concentrations. Although significant
differences in pain scores between the groups were
observed only at 12, 16, and 24 hours, a better
indication of the efficacy of fentanyl was the
significant 5065% reduction in the requirement for
bupivacaine among these patients compared with the
placebo group [6].
Transdermal
fentanyl
(50g/h)
was
compared with patient-controlled analgesia (PCA
morphine) for postoperative analgesia after total hip
arthroplasty, the TDF group showed significantly
diminished VAS score (3.72.2cm versus 7.31.3cm,
P0.0001) and morphine requirement (3.53mg
versus 135mg, P0.0001) as the patient arrived in
the PACU when compared with PCA morphine

group. The cumulative morphine consumption in 48

hour study period was significantly lower in the TDF
group than in the PCA morphine group (54mg
versus 5426mg, P0.0001) [32]. This is in
consistent with the results in our study in which the
TDF group showed a diminished VAS score in the
immediate postoperative period (2.571.3cm) and the
1st time to administer morphine was 1.75.8 hour
postoperatively
with
cumulative
morphine
consumption in 48 hour study period was only
2.53.65mg.
The efficacy of transdermal fentanyl delivery
system for acute postoperative pain after posterior
laminectomy was evaluated (by comparing between
TDF 25g/h, and placebo) and showed that the
transdermal fentanyl group had 60% reduction in
rescue analgesic consumption (p < 0.05); and
displayed lesser VAS scores after the 12th hour,
which maintained until the 36th hour postoperatively
(p < 0.02). Also they reported that all physiological
parameters fluctuated within normal range [38].
Our results are also in agreement with a
study performed by Barrera et al. which assessed the
safety and efficacy of transdermal fentanyl used as
main postoperative analgesic in patients undergoing
dorsal or lumbar spine fusion (by comparing the
TDF, 50g/h, with placebo). VAS scores and rescue
analgesic requirements were lower in transdermal
fentanyl group (p < 0.05) [39].
In our study all cases of the TDF group were
hemodynamically stable. Sedation occurred only in
the 1st 8 hours postoperatively and it was only in the
form of drowsiness that was resolved spontaneously.
There were no reported cases of erythema, respiratory
depression or pruritus. Nausea and vomiting occurred
only in 32 % of cases. Also there were no cases of
respiratory depression.
In the TDF group with delivery rate of 75
g/h the incidence of respiratory depression, sedation
and nausea/vomiting were 11, 22 and 83%
respectively [25]. Another study showed that, the
incidence of respiratory depression was higher in the
TDF group with delivery rate of 75g/h (15%) than
in the TDF group with delivery rate of 50g/h [37].
Minville et al. [32], reported that in the TDF
group there were no reported cases of sedation,
respiratory depression or erythema. Pruritus occurred
in one patient and nausea/vomiting occurred in 7
patients. The only prominent adverse event was the
occurrence of local erythema in 30% of patients
received transdermal fentanyl. The transdermal
fentanyl group had more pruritus and nausea (p <
0.02) [38]. Nausea occurred in (33.3%) of patients in
the TDF group [39], which is different from our study
where no any case of erythema was reported, and no
respiratory depression was observed.

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In the present study, there was an overall

significant reduction in the VAS score in the TDF
group when compared with the C group. Even in the
4th and 8th hours where there was no significant
reduction of the VAS, it was still lower in the TDF
group than the C group. This reduction in the VAS
score was associated with significant reduction in the
postoperative morphine requirement as compared
with the other group.
There were no adverse events that
necessitated patient withdrawal, and there was no
evidence of respiratory depression with no patient
had a marked low respiratory rate, CO2 retention, or
severe hypoxia in the two groups. Although some
cases in both groups were having mild hypoxia and
some degree of CO2 elevation, they did not lost
communication or consciousness and did not require
any intervention, they improved by intermittent
putting O2 mask 40% for a few hours.
We conclude that transdermal administration
of fentanyl 50 g/h 10 hours preoperatively is an
effective noninvasive and convenient technique for
postoperative pain relief after major abdominal
surgery and allows delivery of a potent analgesic
agent with acceptable minimal side effects.

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Corresponding author:
Dr. Samy A. Amr,
Associate Professor of Anesthesiology,
ICU, and Pain Management,
South Egypt Cancer Institute (SECI),
Assiut University, Egypt.
E-mail: [email protected]
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