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Original Article

Pediatric Toxicoepidemiology of Tramadol Intoxication in Iran: A 5‑year

Cross‑Sectional Study
Mohaddeseh Hedayati Goudarzi1, Nastaran Eizadi‑Mood2, Marjan Mansourian3, Soroush Mohammadi‑Jouabadi4,
Payam Peymani5, Ali Mohammad Sabzghabaee2,6

1
Pharmacy Students’ Objective: We aimed to find the toxicoepidemiological indicators of

Abstract
Research Committee, Isfahan
University of Medical
tramadol poisoning in children and also the relationship of these indicators
Sciences, Isfahan, Iran (such as demographic characteristics, and referral time) with the final therapeutic
outcome. Methods: In this cross‑sectional study with retrospective data collection,
2
Isfahan Clinical Toxicology we included the records for all the patients under 18 that have been admitted due
Research Centre, Isfahan to tramadol poisoning between 2010 and 2015 to Noor and Ali‑Asghar  (PBUH)
University of Medical
Sciences, Isfahan, Iran
University hospital which serves as the referral medical center for acute
poisonings management in the central part of Iran and is located in Isfahan.
3
Department of Epidemiology Demographic characteristics, ingested dose, dosage forms, clinical manifestations,
and Biostatistics, Isfahan coingested drugs, and the outcome of treatment for all pediatric patients were
University of Medical
documented and descriptively analyzed. Findings: Demographic and clinical
Sciences, Isfahan, Iran
data of a total of 189  patients including 101  male  (53.4%) with a mean age of
4
Department of Clinical 16.66  ±  2.64  years were abstracted and included in this study. The average time
Pharmacy and Pharmacy between tramadol ingestion and hospital admission was 3.39  ±  3.23  h. Mean
Practice, Isfahan University duration of hospitalization was 12.3  ±  10.7  h. In all cases, the route of drug
of Medical Sciences, Isfahan,
exposure was oral, and the most common form of drug dosage form was 100  mg
Iran
tablets (n = 122) proceeded by 200 mg tablets (n = 32). The mean estimated dose
5
Health Policy Research of ingested tramadol was 1126  ±  1061  mg  (median, 900 range, 50–7000  mg).
Center, Institute of Health, 43.9% of the poisoned patients were high school students, and 23.3% had a high
Shiraz University of Medical school diploma. Intentional intoxications were reported in 93.1% cases and 42.9%
Sciences, Shiraz, Iran
had coingestions. Activated charcoal  (87.3%), gastric lavage  (59.3%), oxygen
6
Department of therapy with mask  (46.6%), naloxone  (11.6%), anticonvulsants  (13.2%), and
Pharmaceutical Care, Imam intubation and ventilation  (5.3%) were done as first‑line therapeutic measures.
Hossein Children’s Hospital, Conclusion: Our results suggest that the trend of acute tramadol poisoning among
Isfahan University of Medical
children is decreasing, mostly accidental in adolescents and commonly intentional
Sciences, Isfahan, Iran
among young children. Proper education to improve emotional intelligence for
young adults and to keep drugs out of reach of the children and safer packaging is
recommended to reduce tramadol poisoning incidence in the pediatric population.
Received: 16‑06‑2019.
Accepted: 18‑10‑2019.
Keywords: Acute poisoning, children, Iran, pediatric toxicoepidemiology,
Published: 28-03-2020. Tramadol

Introduction intoxication can lead to prolonged hospitalization

in about 10% of poisoned patients in intensive care
T oxicoepidemiology uses a combination of
epidemiological methods in medical toxicology
to study the patterns and components of poisoning in a
Address for correspondence:
Dr. Nastaran Eizadi‑Mood, E‑mail: [email protected]
population.[1] Tramadol is an opioid‑like analgesic that
is used to relieve moderate or severe pain.[2] Tramadol This is an open access journal, and articles are distributed under the terms of the
Creative Commons Attribution‑NonCommercial‑ShareAlike 4.0 License, which allows
others to remix, tweak, and build upon the work non‑commercially, as long as
appropriate credit is given and the new creations are licensed under the identical
Access this article online terms.
Quick Response Code:
Website: www.jrpp.net For reprints contact: [email protected]

How to cite this article: Goudarzi MH, Eizadi-Mood N,

Mansourian M, Mohammadi-Jouabadi S, Peymani P, Sabzghabaee AM.
DOI: 10.4103/jrpp.JRPP_20_4 Pediatric toxicoepidemiology of tramadol intoxication in Iran: A 5-year
cross-sectional study. J Res Pharm Pract 2020;9:44-9.

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Goudarzi, et al.: Pediatric toxicoepidemiology of Tramadol intoxication in Iran

units.[3] The safety of prescription and use of this drug ethics for human researches. All patient information was
in children has not been satisfactorily documented yet[4] protected and kept confidential.
and toxic doses are merely determined according to the
Data of all patients aged  <18  years old who were
case reports.
admitted and hospitalized for tramadol poisoning
Two retrospective studies have been conducted on during March 2010–September 2015 were abstracted.
tramadol poisoning in Iran. A  study was conducted on Therefore, the sample size calculation was not needed.[8]
symptoms of tramadol poisoning in cases referred to the To determine the type of needed data, a focus group
emergency department of Noor and Ali Asghar Hospitals consisting of 5 experts in the fields of medical toxicology,
in 2007, that the number of hospitalized patients due to biostatistics, and pharmacoepidemiology was setup, and
tramadol poisoning in 1 year was 184 cases and also two the indicators with toxicoepidemiological importance for
death cases were reported.[5] Another study was carried the objectives of this study were recognized and identified.
out on 114  patients poisoned with tramadol referred to Then the primary topics of interest together with the
poisoning center of Luqman Hospital in Tehran that the main purpose and essential objectives of the project were
clinical symptoms of them included nausea, vomiting, sent via E‑mail to 5 external clinical toxicology experts
loss of consciousness, tachycardia, and seizures.[6] Also, and also to 5 external epidemiologists who were not
in this study, tramadol intake was reported as the most employed at the institute. Twenty five items were finally
common cause of drug poisoning in cases with substance selected for providing the toxicoepidemiological aspect
abuse or mental disorders.[6] of tramadol poisoning in hospitalized children in Isfahan,
Since there is no specific study on tramadol intoxication using a Delphi method.[9]
in Iranian children, and Given the serious side effects of Exclusion criteria included missing data in more than
tramadol, especially seizures that occur even with low 25% of the collected data from patients’ charts.[10]
doses in children, it seems that further and more precise
studies on the causes and effective factors of this kind of Collected data has been reported using descriptive
poisoning on the population of children are needed. statistical analysis, and possible correlations between
epidemiological indicators and the outcomes of the
The purpose of this study was to document and treatment have been analyzed and statistically modeled.
descriptively analyze the toxicoepidemiological All statistical analysis was done by SPSS software
indicators of tramadol poisoning in children and also (IBM Corp., Released 2013. IBM SPSS Statistics for
the relationship of these indicators (such as demographic Windows, Version 22.0, Armonk, NY, USA: IBM Corp.)
characteristics, and referral time) with the final A P < 0.05 considered as statistically significant.
therapeutic outcomes in the Iranian pediatric population.
Results
Methods Demographic and clinical data of a total of 189 patients,
In this retrospective descriptive‑analytic study, which including 101  males  (53.4%) with a mean age of
was carried out in Isfahan (Iran), epidemiological data of 16.66  ±  2.64  (range, 3–18) years, were abstracted and
tramadol poisoned pediatric patients aged  <18‑year‑old included in this study. Of all intoxicated patients, 44.4%
for a 5‑year period  (2010–2015) were abstracted and were residents of east and north east of Isfahan. The
analyzed. These data were gathered via in‑patients’ divided frequency of tramadol intoxication in each year
medical charts of Noor and Ali Asghar  (PBUH) is presented in Table 1.
University hospital  (affiliated with the Isfahan
University of Medical Sciences), which is the referral The average time between tramadol ingestion and
medical center for poisoning emergencies at the central hospital admission  (mean  ±  standard deviation  [SD])
part of Iran. According to a previous study in Isfahan,
at least 77% of drug and nondrug poisonings are Table 1: Frequency of tramadol intoxication in
referred to poisonings center of Noor and Ali Asghar pediatrics of Isfahan, Iran (2010‑2015)
Medical Center.[7] At the same time, more than half of Year Number of children hospitalized
with tramadol intoxication
the remaining 23% that was directly referred to other
2010 47
healthcare facilities, patients were re‑referred to this
2011 37
center after initial stabilization.[7] 2012 29
The study protocol was approved by the institutional 2013 34
board of human studies at Isfahan University of Medical 2014 28
Sciences and was in accordance with Tehran’s code of 2015 (until September) 14

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Goudarzi, et al.: Pediatric toxicoepidemiology of Tramadol intoxication in Iran

was 3.39 ± 3.23 h (range, 0.5–24 h). The mean duration Linear regression statistical analysis of our data
of hospitalization was 12.3  ±  10.7  h  (median, 10 range, showed a significant association between tramadol
1–336  h). In all cases, the route of drug exposure dose, dosage form, and the time elapsed from tramadol
was oral, and the most common form of drug dosage ingestion to hospital admission, with a duration
form was 100  mg tablets  (n  =  122) proceeded by of hospitalization  (P  <  0.001, 0.01, and  <0.001,
200  mg tablets  (n  =  32). The mean estimated dose of respectively).
ingested tramadol  (mean  ±  SD) was 1126  ±  1061  mg
(median, 900 range, 50–7000  mg). About 44% of the Discussion
poisoned patients were high school students, and 23.3% Combined with results of another study which was
had a high school diploma. Intentional intoxications were performed in the same medical center  (Noor Hospital)
reported in 93.1% cases, and 42.9% had coingestions. on epidemiological characteristics of poisoning in
The most frequent coingested drug in 24  patients was vulnerable groups, we can epidemiologically say
clonazepam, followed by alprazolam  (14  patients) that poisoning with tramadol includes about 15% of
and alcohol  (11 patients). Of all patients, 24.3% had poisoning cases in children and adolescents in Isfahan,
a positive history of addiction, of which 4.8% were Iran.[11]
tramadol abusers. Furthermore, 22  patients  (11.6%) had
a history of mental disorders. Clinical manifestations Tramadol poisoning has had a downward trend from
and patients’ symptoms are presented in Table 2. 2011 to 2015, which seems to fit with the overall decline
in poisoning admissions to this center. Furthermore,
Activated charcoal  (87.3%), gastric lavage  (59.3%), reduced distribution amount of tramadol among
oxygen therapy with mask  (46.6%), naloxone  (11.6%), distributing companies and applying stricter rules on
anticonvulsants  (13.2%), and intubation and pharmacies for nondelivery of tramadol to patients
ventilation  (5.3%) were done as first‑line therapeutic without a prescription could be as effective factors in
measures. Despite all of the supportive medical care, this regard.
two (1.1%) patients died (aged 18 and 15 years).
In Iran, tramadol is also included in the red list of
controlled drug products, which by law must be
Table 2: Symptoms of Tramadol intoxication in delivered to patients only with a physician’s prescription,
pediatrics of Isfahan, Iran (2010‑2015)
and in redelivery, the previous prescription must be
Symptom Frequency (%)
received from the patient. Only certain companies have
Nervous system
CNS depression 113 (59.8)
the license for tramadol distribution. However, according
Vertigo 38 (20) to the results of the study, it is clear that in spite of
Seizure 35 (18.5) these provisions, the clients and even their children have
Headache 17 (9) relatively easy access to these drugs. Thus, developing
Coma 4 (2.1) more intelligent measures and the need to monitor the
Ataxia 4 (2.1) implementation of laws belonging to this class of drugs
Motor dysfunction 2 (1.1) by pharmacies and supervising bodies appear to be
Blurred vision 1 (0.5) crucial.
Cardiovascular system
Tachycardia 51 (27)
Almost all the patients in this study were in the age
Bradycardia 2 (1.1) range of 12–18. Only six patients poisoned by tramadol
Hypotension 14 (7.4) were under 6  years, which seems to be logical due to
Hypertension 4 (2.1) the commonly available tramadol form  (tablets and
Respiratory system capsules) and the relatively large size of tablets and
Tachypnea 41 (21.7) capsules.
Bradypnea/apnea 7 (3.7)
In a study conducted in 2013 on the pattern of
Digestive system
poisoning in children in Turkey, most of the poisoning
Vomiting 31 (16.4)
Nausea 10 (5.3)
cases had occurred in the final months of the year
Stomachache 15 (7.9) (January–February), while the lowest rate had been in
Miscellaneous November.[12] In a study published in 2014 in Zahedan,
Itching 13 (6.9) Iran, most of the poisoning cases had occurred in the
Sweating 10 (5.3) fall.[13] In another study in Isfahan carried out on poisoning
Rash 2 (1.1) in the population of children younger than 10  years, the
Fever 1 (0.5) highest rate of poisoning cases had occurred in September,
CNS=Central nervous system while the lowest had occurred in November.[14] It seems

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Goudarzi, et al.: Pediatric toxicoepidemiology of Tramadol intoxication in Iran

that the seasonal density of poisonings varies due to most common drugs used together with tramadol in most
geographical conditions and the cultural background of studies carried out on tramadol.[20] In this study, among the
each region. The highest rate of poisonings in the periods patients taken another medicine together with tramadol,
of our study had happened in May  (11.6%), and in the greatest rate was related to clonazepam  (24  patients),
general, the poisoning rate was higher in the first half of alprazolam  (14  patients) and alcohol  (11  patients), which
the solar year  (52.6%). The lowest rate of poisoning had are all the prescription or illegal drugs. Thus, it seems
also happened in December  (5.8%). Given that the most that further and more stringent measures are required to
important causes of suicide in youth and adolescents are control the activities of pharmacies.
social failures, educational difficulties, and deficiencies
According to 62.4% of patients, tramadol has been
and problems with parents,[15] a higher frequency of
already available in their home, which can indicate
poisoning in this month may be due to simultaneity with
the possibility of the parents’ addiction to tramadol
the examinations in schools.
or using it as a pain reliever. Also, 36.5% of patients
In this study, the majority of patients were high had purchased tramadol from a pharmacy without a
school students or had a high school diploma. Also, prescription. Given the directive of the distribution and
27  patients  (14.2%) had educations lower than their age consumption of narcotic drugs, this reaffirms the need
that 11 of them were of Afghan nationality. for greater oversight of pharmacies.
In this study, the number of males  (53.4%) was slightly The average amount of the drug used by patients in
more than females. This pattern was the same in other this study was equal to 1126  mg  (approximately 12 of
studies on tramadol as well.[6,16] In this study, in males, 100  mg tablets). In previous studies in Iran–  based on
84.1% of poisoning cases were with the intent to the adult population‑the maximum doses used had also
commit suicide, and 15.9% were done for abuse. All of been reported up to 20 grams.[6,21] The average dose used
the females had taken tramadol to commit suicide. In in most studies has been between 1000 and 10,000 mg.
other studies, performed in neighboring countries, the
The most common form of the drug used by patients
suicide rates in females have been more than males.[17,18]
was the 100 mg tablet. There was a significant difference
In general, based on previous research by these authors,
among the use of distribution of drug forms in different
poisoning has been reported as the most common
years. Thus, since the beginning of 2015, no poisoning
nonfatal method of suicide leading to debilitating
with the 100‑mg capsules has been seen, which would
complications in women.[19]
be due to reduced or stopped production of this form of
In this study, 44.4% of the total poisoning cases with the drug or its reduced distribution to pharmacies by the
tramadol in children admitted were related to the eastern manufacturing companies.
region of Isfahan alone, which has a population growth
The mean interval between the estimated poisoning time
and density higher than the average population of the
and the patient’s admission to the hospital was equal to
city. The rate of the illiterate population over  6  years
3.39  h. According to the results, 90.8% of patients had
and the immigrant population are more in these two
been brought to the hospital before the end of 6 h of the
areas than the rest of the Isfahan regions. Therefore,
poisoning. In a study conducted in 2009 in Tehran on
this area seems to be a good option in case of the need
the adult population, the average period time accounted
to establish a new MMT Center or development of the
for 6.1  h  (Min: 0.5  h; Max: 24  h).[6] A comparison of
toxicological health department.
these results with the results of studies on adults shows
Based on our results in this study, the majority of that due to further attention of parents to their children,
poisoning cases were intentional  (93.1%), which seems probably they notice the occurrence of poisoning sooner
reasonable given the age range of the patients that were and bring them to medical centers faster.
often teenagers.
The main symptom in the majority of patients
The majority of patients  (57.1%) had used tramadol on admission has been central nervous system
only, which was the same in other studies. However, depression  (drowsiness, stuporous, or coma), which was
combined drug intoxication was also relatively common, the same way in most studies as well.[5,6,21] Dizziness,
suggesting the surplus pharmaceuticals in households’ nausea, vomiting and headache were all lower than the
drug basket. rates reported in previous studies.[5,6,21] Thus, it seems
that tramadol poisoning is relatively well tolerated by
A study conducted on deaths caused by opioids use in the
children.
U. S. from 1999 to 2011 showed that in 31% of deaths
caused by opioids, benzodiazepines had been used as the Of all patients, 77.8% were discharged without particular
associated medications.[20] Benzodiazepines have been the problems, and 2 patients (1.1%) died. In an earlier study

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Goudarzi, et al.: Pediatric toxicoepidemiology of Tramadol intoxication in Iran

in Isfahan on the adult population, two patients also had Mohammadi‑Jouabadi and Payam Peymani analyzed the
died (1.1%).[5] data and all authors have contributed for corrections and
modifications of the manuscript and are accountable for
The mean duration of patients’ hospitalization was
the originality and validity of the data.
12.3  h  (at least 1  h and the maximum up to 336 h‑the
mid of 10  h). The duration of hospitalization was Acknowledgments
dependent on the dose of the drug used, dosage form, The authors express their deep gratefulness to all nurses
the interval between exposure and acceptance, patient’s and personnel of Isfahan Clinical Toxicology Research
blood glucose level on admission, level of consciousness Centre for their kind help, and also to Professor
on the time of admission, and incidence of seizure. In Farzad Gheshlaghi, the Chairman of the Toxicological
previous studies, a relationship between the duration of Emergency Department at Noor University Hospital, for
hospital stay and the dose of tramadol use was found.[5] his sincere support.
Since a high percentage of patients in this study Financial support and sponsorship
had received tramadol from a pharmacy without a This study was originally a Pharm.D. Thesis project
prescription and given that tramadol is on the red list for MHG and was financially supported by the
of controlled substances and medicines, the need for vice‑chancellery for research and developmnt of Isfahan
greater oversight of the pharmacies in this area seems to University of Medical Sciences (grant number: 293356).
be necessary.
Conflicts of interest
The results show that most of the poisoning cases There are no conflicts of interest.
in children and adolescents over  12  years have been
intentional. Perhaps, strengthening emotional intelligence References
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