Journal of Tropical Pediatrics, 2018, 64, 132–140

doi: 10.1093/tropej/fmx061
Advance Access Publication Date: 7 August 2017
Original paper

Intraosseous Versus Intravenous Access in

Pediatric Septic Shock Patients Admitted
to Alexandria University Pediatric Intensive

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Care Unit
by Ahmed A. El-Nawawy, Omneya M. Omar and Mona Khalil
Department of Pediatrics, Faculty of Medicine, Alexandria University, Alexandria 21321, Egypt
Correspondence: Omneya M. Omar, Department of Pediatrics, Alexandria University, Alexandria 21321, Egypt. Tel:þ201223768859.
E-mail <drmonymagdy@yahoo.com>.

ABSTRACT
The cornerstone of emergency management of sepsis is early, goal-directed therapy. The purpose of
this study was to evaluate the effect of intraosseous (IO) vs. intravenous (IV) access for resuscitation
of patients with septic shock admitted to pediatric intensive care unit. This prospective interven-
tional randomized clinical trial study was conducted on 60 patients with septic shock who need
rapid administration of fluids and drugs; 30 cases were randomly chosen for IO vascular access,
while the other 30 were selected for IV access. The IO route was successfully secured in all cases
with a significant shorter time of vascular access insertion, shorter length of stay and reduction in
mortality in IO group vs. IV group (p ¼ 0.001, 0.045, 0.002, respectively). In pediatric emergencies,
as in case of shock, the use of IO route is recommended to get rapid vascular access as soon as pos-
sible, as it revealed better outcome.

K E Y W O R D S : septic shock, intravenous, intraosseous

INTRODUCTION have a disadvantage of undergoing vasoconstriction

Pediatric septic shock is a major health problem with
high mortality [1]. Alexandria university pediatric in-
tensive care unit (PICU) reported 42% mortality
rate among septic shock cases [2]. The cornerstone
of management is early, goal-directed therapy [3].
Initial resuscitation begins during the first 6 h
with infusion of fluids, optimally titrated while moni-
toring of heart rate, urine output (UOP) and capil-
lary refill (CRT) [4]. Intravenous (IV) access for
fluid resuscitation is more difficult to attain in chil-
dren than in adults [5]. The intraosseous (IO) route
is quick, providing access to a noncollapsible marrow
venous plexus. On the contrary, the peripheral veins
during shock, thus preventing puncture [6].
It is recommended that if it is impossible to ob-
tain peripheral venous access (first option), then the
IO route should be the second choice [6].
The 2010 American heart association (AHA)
stated guidelines that IO access is a rapid, safe, effect-
ive and acceptable initial route for vascular access in
children in cases of cardiac arrest. The guidelines did
not include its use in septic shock [7], besides that, it
was not reviewed in 2015 [8].
The management of shock entails management of
any airway compromise and obtaining rapid peripheral
IV or IO access [9]. There are few data supporting the

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V  132
 Intraosseous Vs. Intravenous Access in Pediatric Septic
use of IO access as first-line therapy in septic shock
management in pediatrics especially in Egypt. The aim
of this work was to evaluate the effect of initial IO ac-
cess vs. initial IV access on resuscitation of patients
with septic shock admitted to PICU.
SUBJECTS AND METHODS
This prospective interventional randomized clin-
ical trial was conducted in a nine-bedded PICU
located in a teaching tertiary care pediatric hospital
(El-Shatby) belonging to Alexandria University
Hospitals from 1 January 2013 to 31 December
2015. An informed consent was obtained from the
patients’ parents or legal guardians concerning all the
procedures applied in PICU. Ethical approval was
obtained from the Ethics Committee of Alexandria
Faculty of Medicine.
This study was conducted on 60 patients with
septic shock, 30 cases were randomly chosen for IO
vascular access using EZ-IO needles and 30 cases
randomly chosen to get IV vascular access by periph-
eral cannulation.
Sample size calculation
Sample size of 30 patients per group is the required
sample to detect a medium-size standardized effect
size of 0.742 [minimum difference in CRT (sec)]
[10] of the primary outcome [11], as statistically sig-
nificant with 80% power and at a significance level of
95% (accepted alpha error ¼ 0.05). Sample size per
group does not need to be increased to control for
attrition bias [12]. The sample size was calculated
using GPower version 3.1.9.2 [13].
Randomization technique: Randomization was
done using permuted block technique to assign 60
patients to either IO or IV in a 1:1 ratio.
Allocation concealment: This was done using
sealed, opaque, closed envelopes.
Inclusion criteria: Inclusion criteria includes chil-
dren between 1 month and 5 years admitted with
septic shock. Septic shock was defined according to
the international pediatric sepsis consensus confer-
ence definitions [14].
Exclusion criteria: Exclusion criteria includes
patients with severe osteoporosis, osteogenesis
 133
imperfecta, cellulitis, osteomyelitis or fractured bone
in the lower limbs.
Primary outcomes: Primary outcomes were the
time for establishing a successful access, time for re-
turn of spontaneous circulation (ROSC) parameters
and mortality.
Secondary outcomes: Secondary outcomes were
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the length of ICU stay (LOS) and access
complications.
Study protocol
The protocol of resuscitation of septic shock was
applied as recommended by the AHA [8] and the
international guidelines for treatment of sepsis and
septic shock in pediatrics using saline, inotropes and
antibiotics [4].
Admission and follow up data were recorded: his-
tory taking and clinical examination. Pediatric Index
of Mortality 2 (PIM2) score was evaluated on admis-
sion [15]. LOS, complications of IV or IO access
and fate were recorded.
A resuscitation team (a resident, two nurses and
independent observer) was available round the
clock at the emergency department. The measured
time for IV or IO successful access was measured
from the time of picking the equipment of the IV or
IO access device until the successful first ad-
ministration of saline. The steps of preparation and
disinfection of insertion site were not included be-
cause they were constant for all patients. Successful
insertion was defined as obtaining a good fluid
flow through the needle without evidence of ex-
travasations. All IO attempts were done using the
tibial insertion route below and medial to tibial tu-
berosity. Failure was defined as more than one at-
tempt. Time was recorded for establishing a
successful access, for ROSC including CRT  2 s,
normal mean arterial pressure (MAP), UOP
>1 ml/kg/h, warm extremities and no pulse differ-
ence between central and peripheral pulsations.
Time for establishing of first 6 h goal-directed ther-
apy central venous pressure (CVP) 8–12 mmHg
and superior vena cava oxygen saturation (ScvO2)
>70% were also recorded. The IO remained for a
maximum 24 h meanwhile other routes of IV access
were obtained.
134  Intraosseous Vs. Intravenous Access in Pediatric Septic
Fig. 1. Consort flow diagram of study design.
Statistical analysis
Data were analyzed using SPSS software package ver-
sion 20.00 (SPSS, Chicago, IL, USA) [16]. Test for
normality was statistically significant, so nonparamet-
ric statistics was adopted. Quantitative data were ex-
pressed using range and median, while qualitative
data were expressed in frequency and percent.
Qualitative data were analyzed using Fisher exact test
to compare between the two groups; quantitative data
were analyzed using Mann–Whitney test. p value was
considered to be significant if < 0.05. The Kaplan–
Meier survival curve was established to demonstrate a
significant difference in the cumulative freedom from
death between the IV and IO group.
The article is registered in Cochrane South
Africa with the identification number for the registry
is PACTR201702002016420.
RESULTS
The CONSORT diagram for the study is depicted in
Fig. 1. The IV and IO groups were similar in the
diagnosis and received the same appropriate manage-
ment except for the use of IO or IV access. The
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body weight for all children ranged from 4 to 14 kg
(Table 1). For fluid resuscitation in both groups, the
rate given was (20 ml/kg) over 5 min and ranged
from 16 ml/min for 4 kg (the lowest body weight)
up to 56 ml/min for 14 kg (the maximum body
weight), which was within the maximum capacity of
IO device [17].
Children in IO group vs. IV group had a significant
shorter time of vascular access insertion, shorter LOS
and reduction of mortality (p ¼ 0.001, 0.045, 0.002,
respectively). However, the ability of blood sampling
and complications from access were significantly
higher in IV group than IO group. The successful first
try was achieved in all IO groups (Table 1).
Time for ROSC, after full resuscitation, revealed
shorter normalization of CRT, equalization of central
and peripheral pulsation, getting warm extremities,
getting UOP >1 ml/kg/h and attaining normal
MAP among IO groups (p ¼ 0.020, 0.007, 0.031,
0.049, 0.035, respectively). The success in reaching
normal CVP and ScvO2 within the first 6 h showed
no significant difference between IV group and IO
group (Table 2).
 Intraosseous Vs. Intravenous Access in Pediatric Septic  135

Table 1. Comparison of clinical characteristics, success of first trial, characteristics of access and
fate between IV and IO groups
Patients and access characteristics IV group IO group p value
(n ¼ 30) (n ¼ 30)

Age (months)
Min-Max 1.0–36.0 1.5–30.0 0.772
Median 5.50 4.00

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Weight (kg)
Min-Max 4.5–14.0 4.0–14.0 0.489
Median 6.00 6.5
PIM2 score (%)
Min-Max 20.4–98.00 32.00–98.00 0.894
Median 55.00 55.15
Length of stay (days)
Min-Max 5.0–25.0 5.0–15.0 0.045*
Median 7.50 6.00
Access time (s)
Min-Max 30.0–120.0 9.0–120.0 0.001*
Median 90.00 52.50
Success of first trial (n, %)
Yes 15 (50.0%) 30 (100.0%) 0.000*
No 15 (50.0%) 0 (0.0%)
Sampling from access (n, %)
Yes 30 (100.0%) 13 (43.3%) 0.000*
No 0 (0.0%) 17 (56.7%)
Complications of access (n, %)
Yes 8 (26.7%) 0 (0.0%) 0.000*
No 22 (73.0%) 30 (100.0%)
Fate (n, %)
Discharged 18 (60.0%) 28 (93.3%) 0.002*
Deceased 12 (40.0%) 2 (6.7%)

*Statistically significant (p < 0.05).

Deceased patients had significantly longer time of
all ROSC parameters including normalization of CRT,
equalization of central and peripheral pulsations, get-
ting warm extremities, getting UOP >1 ml/kg/h and
attaining normal MAP (p ¼ 0.000, 0.002, 0.000, 0.037,
0.017, respectively). The percent of patients success-
fully reaching normal CVP and ScvO2 within the first
6 h were significantly higher in the discharged group
(p ¼ 0.002, 0.002, respectively) (Table 3).
Figure 2 shows the Kaplan–Meier survival curve
of the cumulative survival with a prolonged hospital
stay (mortality in sense to time). It showed no in-
crease in cumulative hazards of mortality with the
LOS among IO group, whereas there were increased
cumulative hazards of mortality with prolonged LOS
among IV group. The two survival curves for IV
group and IO group are statistically significant
(v2 (log-rank) ¼ 4.385, p ¼ 0.036).
DISCUSSION
Our study showed that the IO route was successfully
secured in all cases but the IV line could not be
secured in 50% of patients. There was a significantly
shorter time of vascular access insertion, shorter LOS
and reduction in mortality in IO group vs. IV group.
136  Intraosseous Vs. Intravenous Access in Pediatric Septic

Table 2. Comparison of time taken for ROSC parameters after full resuscitation between IV and
IO group
Time taken for ROSC to be restored IV group IO group p value
(n ¼ 30) (n ¼ 30)

CRT <2 s* (min)

Min-Max 5.0–120.0 5.0–35.0 0.020*
Median 30.00 15.00

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No pulse difference (between central and peripheral) (min)
Min-Max 10.0–360.0 5.0–90.0 0.007*
Median 75.00 42.50
Warm extremities (min)
Min-Max 10.0–720.0 5.0–360.0 0.031*
Median 120.00 60.00
UOP 1 ml/kg/h (min)
Min-Max 30.0–480.0 20.0–360.0 0.049*
Median 195.00 90.00
MAP for age (min)
Min-Max 5.0–240.0 5.0–120.0 0.035*
Median 75.00 52.50
Normalized CVP (n, %)
Yes 23 (76.7%) 24 (80.0%) 0.754
No 7 (23.3%) 6 (20.0%)
Superior vena caval O2 saturation 70% (ScvO2) (n, %)
Yes 23 (76.7%) 24 (80.0%) 0.754
No 7 (23.3%) 6 (20.0%)

*Statistically significant (p < 0.05).

Nonreversal of shock in sepsis often progresses to
multiple organ failures (MOF) with a mortality rate
of 54% [18]. Patients treated rapidly had a signifi-
cantly low mortality rate [19]. In the present study,
the time needed to reverse shock and reach the first
6 h goal and therapeutic end points was significantly
longer in deceased group vs. discharged.
The failure rates of IV access in emergency situ-
ations are between 10% and 40% and the average
time necessary for peripheral IV catheterization was
reported to be 2.5–13 min, and sometimes even up
to 30 min [17, 20]. Rosetti et al. [21] stated that in
pediatric patients, in a state of shock or cardiac ar-
rest, vascular access may not be attainable in 6%
cases; Banerjee et al. [10] reported that the IV can-
nulation was successful in 66% children with severe
dehydration, while the IO route achieved in all the
cases within the first 5 min. Similarly, the present
study reported that success of the first attempt of vas-
cular access was significantly higher in the IO group
vs. the IV group (100% vs. 50%). Furthermore,
Reasdes et al. [22] showed that individuals random-
ized to tibial IO access had a successful first attempt
at vascular access (91%) compared with either hu-
meral IO access (51%) or peripheral IV access
(43%). Moreover, Fiorito et al. [23] reported that
first attempt success was achieved in 78% of IO ac-
cess and Myers et al. [24] reported it between 81%
and 100% in IO access.
In the present study, there was a significantly
shorter median access time in the IO group vs. the
IV group (52.5 s vs. 90 s). This is in agreement with
Banerjee et al. [10] who reported that average time
taken to obtain IO access was 67 s vs. 129 s for IV ac-
cess. However, some studies [17, 25] reported IO
time >1 min; this depends on how the timing was
 Intraosseous Vs. Intravenous Access in Pediatric Septic  137

Table 3. Comparison of the clinical variables between discharged and deceased patients
Clinical variables Discharged Deceased p value
(n ¼ 46) (n ¼ 14)

PIM2
Min-Max 20.4–90.0 49.0–98.00 0.000*
Median 48.10 90.50
Length of stay (days)

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Min-Max 5.0–25.0 5.0–11.0 0.200
Median 6.00 8.00
Vascular access time (s)
Min-Max 9.0–120.0 9.0–120.0 0.881
Median 60.00 75.00
CRT 2 s (min)
Min-Max 5.0–35.0 15.0–120.0 0.000*
Median 15.00 45.00
No pulse difference (min)
Min-Max 5.0–120.0 15.0–360.0 0.002*
Median 60.00 105.00
Warm extremities (min)
Min-Max 5.0–360.0 30.0–720.0 0.000*
Median 60.0 210.0
UOP 1 ml/kg/h (min)
Min-Max 20.0–360.0 30.0–480.0 0.037*
Median 150.00 240.00
MAP for age (min)
Min-Max 5.0–180.0 20.0–240.0 0.017*
Median 60.00 97.50
Normalized CVP (8–12 mmHg)
Yes 42 (87.5%) 5 (41.7%) 0.002*
No 6 (12.5%) 7 (58.3%)
ScvO2 (>70%)
Yes 42 (87.5%) 5 (41.7%) 0.002*
No 6 (12.5%) 7 (58.3%)

*Statistically significant (p < 0.05).

calculated. The adults were studied in the emergency
department; Leidel et al. [17] reported that mean
time required for IO access (2.3 6 0.8 min) was sig-
nificantly lower vs. central venous catheterization
(CVC) (9.9 6 3.7 min). Similarly, Leidel B.A. [25]
reported that the median time for IO access was sig-
nificantly lower vs. CVC (2 vs. 8 min).
In contrast to the present study and the above-
mentioned results of various articles, Reasdes et al.
[22] reported that the time to initial success was
significantly shorter for individuals assigned to the
tibial IO access group (4.6 min) compared with
those assigned to the humeral IO access group
(7.0 min) and neither time was significantly different
from that of the IV access group (5.8 min). This
difference could be explained that the study was
done on adult patients experiencing a nontraumatic
out-of-hospital cardiac arrest and the longer timing is
because time to successful vascular access was meas-
ured as the interval between paramedic arrival on
138  Intraosseous Vs. Intravenous Access in Pediatric Septic
Fig. 2. Kaplan–Meier survival curve using cumulative hazard.
scene and documented successful vascular access
placement.
IO blood aspirate may serve as a reliable alterna-
tive to venous access, especially for hemoglobin and
hematocrit levels. Exceptions are CO2 levels and
platelet counts, which may be lower, and white blood
cell counts, which may appear elevated [26]. In the
present study, blood sampling was successful only in
43.3% of IO needle insertion while it was signifi-
cantly higher (100%) after IV cannulation. Blood
sampling was possible later on after the first success-
ful fluid infusion shot.
There were no complications concerning the IO
needle insertion in our cases; this is in concordance
with other reports [27, 28]. Fiorito et al. [23] re-
ported complications in 12% of IO insertion but all
limited to infiltration and local edema.
In the present study, the median time of return of
normal CRT and MAP was significantly shorter in
IO group vs. the IV group. Each hour delay in rever-
sal of hypotension or reaching CRT <2 s is associ-
ated with two-fold increase in the odds ratio of death
from MOF [29].
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In the present study, there was a significantly lon-
ger time to improve UOP >1 ml/kg/h, normalize
warm extremities and equalize central and peripheral
pulse difference in the IV group vs. IO group. This
delay, besides the other studied factors, could be an
important factor for higher mortality in the IV
group.
In the present study, the median LOS was signifi-
cantly shorter in the IO group vs. IV (6 vs. 7.5 days).
The Kaplan–Meier survival curve using cumulative
hazards demonstrated that there is an increase in
mortality risk with prolonged LOS in IV group vs.
IO group where no cumulative hazards were seen.
The mortality in IV group was 40% vs. 6.7% in the
IO group. Both groups did not differ statistically in
median age and weight. Moreover, their condition
on admission as revealed by the median PIM2 score
showed no statistical significant difference. The fac-
tor of early start of resuscitation seems to be crucial.
To summarize, the longer access insertion time
and LOS in the IV group vs. IO group could be ex-
plained by decreased vasodilatation in IV group. The
result would be the delay of ROSC parameter and
 Intraosseous Vs. Intravenous Access in Pediatric Septic
ultimately linked with a significantly higher mortality
rate in the IV group.
The limitation of the present study is that it is a
single-center study; multicentered randomized clin-
ical trials are needed to confirm the present study
results.
CONCLUSION
The present study substantiates literature conclu-
sions that IO insertion is safe, effective with minimal
complications and supports its early use in emer-
gency situations for rapid administration of fluids
and medications to children.
Time spent to get IV line could be crucial in pre-
venting morbidity and mortality. Cost is a key con-
sideration for providing any element of patient care.
Although IO vascular access devices tend to be more
expensive than peripheral IV catheters, future studies
assessing the cost benefit of IO vs. IV access should
be performed.
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