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Pattern of Acute Antipsychotic Drug- Toxicity in Children at Assiut University Children Hospital

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

From 1 Months to 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: October 2023
See protocol details

Summary

Principal SponsorAssiut University
Study ContactEsraa RamadanHusseinMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 30, 2023

Actual date on which the first participant was enrolled.

Acute poisoning in pediatrics is very common as it is one of the prominent causes of mortality and morbidity worldwide as, children are curious and they explore at home and around. Acute poisoning has also been the 3rd most common treated injury for children less than 16 years in the emergency units. Accidental ingestion is one of the most important causes of poisoning in children and is most prevalent between 1-5 year olds. During adolescence, medications used for committing suicide are the main cause of poisoning. Drug ingestion is the commonest cause of acute poisoning among children according to poison control centers records all over the world. A great percent of hospital admission cases involves drug poisoning, particularly with psychotropic drugs such as sedatives, antidepressants, and neuroleptics. Antipsychotics are primary used to treat agitated behavior , various neurological conditions (motor tics ,chorea and dystonia),schizophrenia, manic phase of bipolar disorders; however they are often used to treat nausea, vomiting and headache. Antipsychotics toxic effects include anticholinergic and extrapyramidal syndromes as well as CNS and cardiovascular depression. Antipsychotics are classified as ""typical"" or ""atypical."" They are also classified by their chemical structure as first-generation, including butyrophenones (droperidol, haloperidol) and phenothiazines (chlorpromazine, promethazine), and second generation such as olanzapine, risperidone, quetiapine, and more recently ziprasidone and aripiprazole. Second-generation antipsychotics, or ''atypical antipsychotics,'' were introduced in 1989 and were anticipated to be equally effective for treatment of psychosis.They also had the advertised advantage of fewer extrapyramidal side effects such as dystonias, akathisia, parkinsonism, and tardive dyskinesia, at therapeutic dosing. These medications are now first-line therapy in the treatment of schizophrenia and are additionally being used in a wide array of conditions in both adults and children, including bipolar disorder, tic disorders, eating disorders, obsessive-compulsive disorder, and developmental disorders such as autism. Risperidone and aripiprazole were approved by the FDA in 2006 and 2009, respectively, to treat irritability associated with Autism spectrum disorder (ASD). Antipsychotics overdose is common in Western society. In 2010, poison control centers in the US received about 43 000 calls complaining of atypical antipsychotics overdose. The actual incidence of atypical antipsychotics overdose is greater than announced, due to underreporting. Overdose of an atypical antipsychotic is presented clinically with multiple disorders as CNS depression, tachycardia and orthostatic hypotension. Supportive measures as maintaining patent airway, assessment of breathing, maintaining adequate circulation are necessary before confirmation of intoxication. Evaluation and management of antipsychotic drugs toxicities needs high level of suspicion, careful history taking, proper examination, and investigations to improve the outcome of such patients.

Official TitlePattern of Acute Antipsychotic Drug- Toxicity in Children at Assiut University Children Hospital
NCT06125275
Principal SponsorAssiut University
Study ContactEsraa RamadanHusseinMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 Months to 18 Years

Range of ages for which participants are eligible to join.

Criteria

3 inclusion criteria required to participate
Patients with history of exposure to antipsychotic drugs aged from 1month to 18 years old, who presented to emergency department.

Both sexes.

Diagnosis is according to clinical features suggestive of possible antipsychotic drug- toxicity.

4 exclusion criteria prevent from participating
neonates less than one month .

History of chronic exposure.

Food poisoning and other poisonous.

Other drugs toxicity.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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