e u r o p e a n j o u r n a l o f p a e d i a t r i c n e u r o l o g y 1 9 ( 2 0 1 5 ) 1 4 9 e1 5 4

Official Journal of the European Paediatric Neurology Society

Original article

Efficacy and safety of intramuscular midazolam

versus rectal diazepam in controlling status
epilepticus in children

Ali Akbar Momen a, Reza Azizi Malamiri a,*, Ali Nikkhah a,

Maryam Jafari b, Abbas Fayezi b, Kourosh Riahi b, Elham Maraghi c
a
Department of Paediatric Neurology, Golestan Medical, Educational, and Research Center, Ahvaz Jundishapur
University of Medical Sciences, Ahvaz, Iran
b
Department of Paediatrics, Golestan Medical, Educational, and Research Center, Ahvaz Jundishapur University of
Medical Sciences, Ahvaz, Iran
c
Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences,
Tehran, Iran

article info abstract

Article history: Objective: The aim of this study was to evaluate the efficacy and safety of intramuscular
Received 14 July 2014 midazolam in controlling convulsive status epilepticus in children, by comparing it with
Received in revised form rectal diazepam.
27 October 2014 Methods: In this randomized trial, 100 children (50 in each group) with convulsive status
Accepted 16 November 2014 epilepticus aged 1 month to 16 years were enrolled and randomly assigned into two groups
to receive either 0.3 mg/kg intramuscular midazolam or 0.5 mg/kg rectal diazepam. Main
Keywords: outcome measure was stopping of all motor activity after drug administration. Another
Convulsive status epilepticus measures were times between patient's arrival to emergency department till drug
Rectal diazepam administration, between drug administration to seizure cessation, and between patient's
Intramuscular midazolam arrival to seizure cessation.
Children Results: Both medication were effective for seizure control and no significant difference was
found between successful treatments after administering the medication (P ¼ 0.061). In the
midazolam group, in 96% (48/50) of cases treatment was successful and in the diazepam
group, in 94% (47/50) of cases treatment was successful. Time from arrival to administering
the medication was significantly shorter in midazolam group (P ¼ 0.017). The majority of
seizures in midazolam group were stopped in less than 66 s (median) compared to
130 s (median) for diazepam group, (P < 0.001). No serious adverse effects were seen in both
groups.

* Corresponding author. Department of Paediatric Neurology, Golestan Medical, Educational, and Research Center, Ahvaz Jundishapur
University of Medical Sciences, #90, Golestan Blvd., P.O. Box 6135733118, Ahvaz, IRAN. Tel./fax: þ98 613 3743063.
E-mail address: [email protected] (R. Azizi Malamiri).
http://dx.doi.org/10.1016/j.ejpn.2014.11.007
1090-3798/© 2014 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

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150 e u r o p e a n j o u r n a l o f p a e d i a t r i c n e u r o l o g y 1 9 ( 2 0 1 5 ) 1 4 9 e1 5 4

Conclusion: IM midazolam is not superior but may be at least as effective as rectal diazepam
for controlling of status epilepticus in children. Midazolam via IM route could be one of the
choices in children with convulsive status seizures who have difficult IV access.
© 2014 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights
reserved.

Opening the vials of diazepam and drawing the content into a

1. Introduction syringe and diluting the content by normal saline and
attachment of a tube to syringe before insertion into the
Convulsive status epilepticus is one of the most common rectum would lead to significant delay in drug administration.
neurological emergencies that occurs in children. Such sei- Because of these limitations, we carried out a trial to show the
zures usually are associated with high morbidity and mor- efficacy of IM midazolam as the initial agent in controlling
tality, therefore, urgent treatment is warranted. Based on the convulsive status seizures in children who had no IV access
etiology, co-morbidities, and duration of seizures, long term comparing it with rectally administered diazepam.
outcomes would be different and all the previous studies
claimed that early treatment by an effective agent usually
leads to better outcome. To cease convulsive seizure rapidly, 2. Materials and methods
the medication should reach the brain quickly while lacks
serious adverse effects. For this purpose, IV administration of 2.1. Study design and location
anticonvulsants could be the best route but in a child with
active convulsions IV access could be very difficult, therefore, We conducted a not blinded, controlled, randomized trial to
other routes for drug administration should be considered.1e4 evaluate the efficacy and safety of IM midazolam to control
Standard protocols recommend IV diazepam and loraze- status epilepticus in children comparing it with rectal diaz-
pam as the standard acute treatment for status epilepticus but epam as control group. The study was conducted at the
as previously mentioned when getting IV access is difficult emergency departments of Golestan and Abuzar Hospitals, two
other routes for drug administration should be considered. University affiliated tertiary referral children's hospitals in
Rectal, buccal, and nasal routes are well-studied for drug Ahvaz, Iran. Golestan Hospital is an urban university affiliated
administration in convulsive status epilepticus. Many studies general Hospital with pediatric subspecialty wards and Abuzar
recommend rectal diazepam for home treatment of status Hospital is an urban university affiliated pediatric referral
seizure and in many emergency departments in our country Hospital. The study was conducted between November 2012
the rectal diazepam is the main initial treatment for status and September 2013. The study design was approved by the
seizures. One of the limits of rectal diazepam is that many ethical board committees of the medical centers and Ahvaz
parents in developed and developing countries are not satis- Jundishapur University of Medical Sciences. Because of the
fied to administer drug via the rectum.1,3 study design and situation, taking written informed consents
A number of studies demonstrated that buccal and nasal from the parents or care givers had many complexities but
midazolam could be an effective and safe choice for control- staffs at the emergency departments who performed the study,
ling convulsive status seizures but these routes could be un- were fully trained to rapidly describe the situation to the par-
reliable in a number of patients because it may be very ents and to give a verbal consent from them to participate in
difficult to open the mouth of the patient during the seizure the study. After this brief description, either during seizure
when the jaw is locked and nasal congestion and copious control or after seizure control written informed consents were
discharges during active seizures could lead to insufficient taken from all the parents.
absorption of drug via nasal mucosa.1,5e15
IM drug administration during active seizures could be 2.2. Patients
very easy and safe and a number of studies demonstrated that
IM midazolam could be an initial agent for controlling status We enrolled children aged one month and older presenting
seizures in home, office, and pre-hospital settings. Previous with convulsive status epilepticus. We used a practical defi-
studies indicated that anticonvulsant activity of IM mid- nition for convulsive status epilepticus to define eligible pa-
azolam is equal to or better than diazepam, moreover, after IM tients that is proposed by Lowenstein et al.,20 who defined
administration, midazolam would be completely absorbed status epilepticus as a continuous, generalized, convulsive
and reached the brain rapidly.3,4,15e19 seizure lasting longer than 5 min. Based on this definition, we
Many children with status epilepticus who referred to our enrolled all children who were convulsing while arriving to
emergency departments have difficult IV access and rectal emergency departments. We enrolled all children whose
diazepam administration in our country is mostly unaccept- parents brought them to the emergency departments and
able by parents. In addition, rectal gel diazepam is very those children who were brought by paramedics were
expensive and inaccessible in our country and almost always enrolled only when they had no IV access. None of the chil-
injectable formulation of diazepam instead of rectal gel is dren was enrolled more than once for different episodes of
administered via rectum after dilution with normal saline. status epilepticus.

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2.3. Inclusion and exclusion criteria 2.6. Time measurement

We enrolled all those children aged one month and older who In each center a fully trained staff measured the following
were convulsing while attending our emergency departments. times using a digital chronometer; time from arrival to
We excluded all those children who had one of the following administer medication, time to cessation after medication,
criteria; those children with convulsive status seizures who time to cessation after arrival, and time of any seizure recur-
had an established IV access on arrival to our emergency de- rence after stopping of the seizures. These staff were not
partments, those children who were previously administered blinded to treatment groups but for reducing bias they were
rectal or nasal benzodiazepines by parents or paramedics, all asked to measure precise times and to register them. To
those children whose parents were reluctant to give a verbal reduce inter observer variations in time measurements the
consent to participate in the study, and all those children staffs who registered the times had a full mobile access to one
having serial seizures without recovery of consciousness be- of the research team members to clear ambiguities in time
tween seizures. We also excluded those children who had a measurements.
history of serious adverse reactions to IM midazolam or rectal
diazepam. 2.7. Adverse effects

In all children respiratory rate and blood pressure were

2.4. Randomization and intervention
assessed and registered to monitor adverse effects.

Consecutive patients were enrolled and randomized to

2.8. Statistics and data analysis
receive either IM midazolam or rectal diazepam. We used a
random number table for randomization. Because of our
Based on the previous studies, the sample size was calculated
emergency departments' protocol for status seizures con-
with the Type I error a ¼ 0.05 and Type II error b ¼ 0.2. Based on
trol, in all children who enrolled into the study an IV access
previously published findings, the necessary sample size was
was established to administer an anticonvulsant with long
calculated to be at least 50 patients in each treatment group in
lasting effect after seizure control by either IM midazolam
order to detect a difference in efficacy with the power of
or rectal diazepam. To reduce bias in time measurements
80%.1,3 For each patient randomized to receive either mid-
after administering the medication, in each center one set of
azolam or diazepam, the median and the mean (±SD) time
staff conducted the intervention and measured the times
after arrival to administer medication, time to cessation after
and another staff were getting IV access and attempts were
medication, time to cessation after medication were
made to secure IV access after the medications were given.
measured and showed. All data were analyzed for normality
IM midazolam was used with a dose of 0.3 mg/kg and rectal
before choosing parametric and non parametric tests. Quan-
diazepam was used with a dose of 0.5 mg/kg. Midazolam
titative variables were analyzed using student t test or Mann
was injected into the left quadriceps muscle if the child was
Whitney U when appropriate. For categorical data, we used
younger than two and if the child was older than two the
either Fisher exact or c2-test when appropriate. In all statis-
left deltoid muscle was considered for injection. In the
tical evaluations, P < 0.05 was considered significant. To
diazepam group, the drug was drawn into a syringe, a tube
reduce the bias in data analysis, all data were analyzed by a
was inserted into the rectum and the syringe was attached
biostatistician who was blinded to the study purpose and
to the tube, following which the diazepam was expelled into
groups.
the tube. To ensure that the drug was administered
correctly, the buttocks were held together for 5 min to pre-
vent expulsion and then the tube and the syringe were
removed. All children who enrolled were admitted for at 3. Results
least 48 h depending on the cause of seizures and the
required investigations were conducted including; blood 3.1. Baseline characteristics
chemistry, EEG, CT, or MRI.
A total of 100 children (50 in each group) with generalized
convulsive status seizures were enrolled. The baseline
2.5. Outcome measures

The main outcome measure was stopping of all motor activity Table 1 e Baseline characteristics of the children in both
after drug administration without recurrence within groups.
60 min after stopping of seizures, otherwise, the treatment Characteristics Midazolam n ¼ 50 Diazepam n ¼ 50
was considered to be a failure and the patient was treated with
Boys, n (%) 31 (62) 27 (54)
IV diazepam then IV phenytoin which are the standard ther-
Girls, n (%) 19 (38) 23 (46)
apy in our emergency departments. However, these patients Age (years), 2 (1.1) 2.5 (1.4)
with treatment failure were considered in data analysis. mean (SD) [range] [4 mone15 yr] [5 mone13 yr]
Treatment was defined successful if the seizures were Seizure etiology, n (%)
stopped in less than 10 min after administration without Febrile status 23 26
recurrence after 60 min of cessation of all motor activities. Remote symptomatic 15 10
Idiopathic 12 14
None of the children had EEGs to assess seizure control.

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characteristics of the children in both groups are summarized

in Table 1. Participants in the treatment groups were not 4. Discussion
significantly different in terms of age, gender, and seizure
etiology. Previous studies in adults and children recommended that
ideal medications for seizure control in status epilepticus
should be easy to use, be effective, not have serious adverse
effects, and show anticonvulsive effects rapidly to reduce the
3.2. Response assessment
complications of status epilepticus.1,2,21 Results of this study
demonstrated that both IM midazolam and rectal diazepam
3.2.1. Seizure control and seizure recurrence
have the main characteristics of an ideal medication for
Our results showed that both medication were effective for
controlling of status epilepticus in children. Both medications
seizure control and no significant difference was found be-
were administered rapidly, were effective, didn't have serious
tween successful treatments after administering the medi-
adverse effects, and in the majority of children (more than
cation (P ¼ 0.061, c2 test). In the midazolam group, in 96% (48/
90%) in both groups seizures were stopped in less than 10 min.
50) of cases treatment was successful and in 4% (2/50) treat-
These finding indicate that IM midazolam is not superior but
ment was failed. In the diazepam group, in 94% (47/50) of cases
may be at least as effective as rectal diazepam for controlling
treatment was successful and in 6% (3/50) the treatment was
of status epilepticus in children, therefore, along with buccal
failed. Interestingly, none of the patients in both groups
and nasal routes that have suggested by previously well con-
showed recurrence with 60 min after stopping of all motor
ducted studies in children, midazolam via IM route could be
activities.
one of the choices in children with convulsive status seizures
who have difficult IV access.
3.2.2. Time measurements
Speed of administration of anticonvulsant is one of the
We compared both groups of patients for time from arrival to
main issues in children with convulsive status seizures who
emergency departments to administering the medication,
have difficult IV access. Rectal diazepam is routine in our
time from administering to stopping of seizures, and finally
emergency departments for this situation, but many parents
we calculated time from arrival to stopping of seizures. Our
are not satisfied with rectal route and parents' decision for
results showed that time from arrival to administering the
route of drug administration could lead to significant delay in
medication had significant difference between both groups
seizure control. Our results indicated that in both groups of
(P ¼ 0.017, by ManneWhitney Rank Sum Test, T ¼ 2575.500
the trial the median time from arrival to emergency depart-
n(small) ¼ 47 n(big) ¼ 48). Interestingly, our results showed
ment to administering the medication was about 1 min.
that after administering the medication, the majority of sei-
Although our results showed that median time in both groups
zures in midazolam group were stopped in less than 66 s and a
was 65 s but a significant statistical difference was found be-
significant difference was found between times from admin-
tween two groups (P < 0.017 by Mann Whitney Rank Sum
istering the medication to stopping of seizures between both
Test). This finding could be confusing but after reviewing the
groups (midazolam, median 66 s, diazepam, median 130 s,
raw data of the time of arrival to drug administration we
P < 0.001, ManneWhitney U Statistic ¼ 385.500, T ¼ 2998.500
found that the distribution of data was not normal, therefore
n(small) ¼ 47 n(big) ¼ 48). These times are summarized in
we had to compare two groups using non parametric test
Table 2.
(Mann Whitney Rank Sum Test) and this analytical approach
could explain the statistical significant between two groups.
3.2.3. Adverse effects
This finding indicated that in children with convulsive status
Interestingly, none of the children in our study showed
seizures and difficult IV access both rectal diazepam and IM
respiratory depression in both groups but one patient in
midazolam could be rapid to administer but if the parents are
the midazolam group who mistakenly received double
not satisfied by the rectal route IM midazolam could be more
dose of midazolam (0.6 mg/kg) and developed signs of res-
acceptable.
piratory depression. Fortunately, this patient was a child
When we analyzed times from arrival to emergency
with febrile status seizure who was recovered fully after a
department to drug administration and to stopping of seizure
simple respiratory aid of oxygen and Ambu bag and mask
activities in our patients (Table 2.) we found that our mea-
ventilation.
surements are somehow short comparing to the results of
previous studies, therefore, we decided to precisely re-
evaluate our time measurements. Interestingly, after re-
Table 2 e Times from arrival, to administering the evaluation, we found that all time measurements were
medication, and to stopping the seizures in both groups. correctly typed and inserted into our database. We have no
Time, seconds (medians) Midazolam Diazepam P precise explanation for this discrepancy between our mea-
[range] surements and previous studies but the followings possibil-
From arrival to administering 65 [54e95] 65 [55e190] 0.017 ities could be considered. One of the shortcomings in the
From administering to 66 [24e245] 130 [45e600] <0.001 design of our study was that duration of seizures prior to
stopping of seizures arrival to emergency department were not considered and we
From arrival to stopping of 127 [83e320] 243 [115e725] <0.001
enrolled all children with convulsions while attending to
seizures
emergency department. It is obvious that short seizures have
P by ManneWhitney Rank Sum Test. actual short stopping time after anticonvulsants

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 e u r o p e a n j o u r n a l o f p a e d i a t r i c n e u r o l o g y 1 9 ( 2 0 1 5 ) 1 4 9 e1 5 4 153

administration and it was possible that some of our patients adverse effects such as IM injection-site complications were
had short duration of status seizures before enrollment into not considered to monitor, therefore we have no idea about
the study. In addition, we think that over the trial, skill of our this complication, moreover, parent satisfaction about child
staff for drug administration was improved, therefore, the treatment was not considered in our outcome measures.
median time for drug administration after arrival to emer- In conclusion, results of our study indicated that both IM
gency department was significantly reduced in both groups. midazolam and rectal diazepam could be effective and safe in
Our results were comparable to results of previous studies controlling convulsive status epilepticus in children. More-
in adults and children. In a prospective randomized study, over, our results demonstrated that IM midazolam is not su-
Chamberlain et al. showed that IM midazolam is an effective perior but may be at least as effective as rectal diazepam for
anticonvulsant for children with motor seizures. They controlling of status epilepticus in children, therefore, along
enrolled 24 children and gave them IM midazolam (13 pa- with buccal and nasal routes that have suggested by previ-
tients) or IV diazepam (11 patients). The medications were ously well conducted studies in children, midazolam via IM
successful in 22 patients but in the midazolam group the route could be one of the choices in children with convulsive
medication administered sooner than diazepam (P ¼ 0.001) status seizures who have difficult IV access.
and the seizures in midazolam group were ceased more
rapidly than diazepam group (P ¼ 0.047). They reported no
serious adverse effect after IM midazolam. They indicated 5. Conflict of interest statement
that getting IV access in a convulsive child is difficult and
other routes of drug administration should be considered and There are no conflicts of interest to declare.
based on their results recommended that IM midazolam could
be a suitable choice.3
In a large double blind, randomized, noninferiority trial,
Acknowledgments
Silbergleit et al. compared IM midazolam versus IV lorazepam
in pre-hospital status epilepticus treatment. In this study, IM
This paper is from the thesis of Maryam Jafari, M.D., regis-
midazolam was injected via an intramuscular autoinjector by
tration number D/766. The Research Deputy of Ahvaz Jun-
trained paramedics. In an intention to treat analysis, 448 pa-
dishapur University of Medical Sciences provided financial
tients received IM midazolam and 445 received IV lorazeapm.
and logistic support for this study, but had no role in study
The main outcome measure was seizure termination and
design; data collection, analysis, or interpretation; writing the
secondary outcome measures were endotracheal intubation
report; or in the decision to submit the article for publication.
within 30 min after ED arrival, hospitalization, ICU admission,
The authors are grateful to all parents and patients for their
recurrent seizure within 12 h after ED arrival, hypotension, IM
participation in this study. We are extremely indebted to the
injection-site complications, IV injection-site complications,
authorities of the Research Deputy of Ahvaz Jundishapur
length of ICU stay, and length of hospital stay. Results of this
University of Medical Sciences for their financial and logistic
study showed that IM midazolam was noninferior to IV lor-
support (grant number U-91229).
azeapm in stopping seizures before attending EDs (P < 0.001),
moreover, safety scale of IM midazolam was comparable to IV
lorazepam and the frequencies of endotracheal intubation, references
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