Clinical trial NCT01981213: Attempted Suicide With Acetaminophen Among 8-18 Year-old Children / Adolescents in Denmark
Official title: Attempted Suicide With Acetaminophen Among 8-18 Year-old Children / Adolescents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatic Injury
Keywords: Acetaminophen
Suicide
Attempts
Early Predictors of Hepatic Injury
Childhood Suicidal Behaviour
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 500
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric Department, children/adolescents who have tried to commit suicide with acetaminophen (8-18 years-old)

Brief summary: A: Early predictors of hepatic injury after suicide attempt with acetaminophen:

To explore the following in a pediatric population with acetaminophen overdose due to suicide attempt: 1) the prevalence of episodes of pre- and in-hospital vomiting and the relationship between the total number of vomiting episodes and hepatic injury, 2) the relevance of the early initiation of N-acetylcysteine (NAC) treatment to hepatic injury, and 3) the presence/absence of illness prior to the suicide attempt and hepatic injury.

B: Characteristics, social behaviour, trends and risk factors:

1. To explore the relationship between children admitted to a paediatric department as a result of suicide attempts with acetaminophen and their parents and friends. 2. To determine the extent to which the children had attempted to speak to their parents or other adults about their problems before their suicide attempts. 3. To determine the prevalence of self-mutilation among children with suicidal behaviour. 4. To examine the reasons for these suicide attempts.

C: Establishment of the expression of cytochrome P450 in a pediatric including the age-adjusted activities.

Urine samples will be analyzed using an HPLC tandem mass spectrometric method, which we have already established in our lab.

There will be categorized three groups for comparison:

1. An age-appropriate background population (approximately 200 patients)
2. Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic injury (approximately 50 patients)
3. Other pediatric patients admitted to their local hospital because of acetaminophen poisoning (approximately 200 patients) A control urine sample will be analyzed three months after the suicide attempt.


Eligibility criteria: Inclusion Criteria:

* 8-18 years-old, who tried to commit suicide with acetaminophen.
* Children are only included if they have answered all our standard questions.

Exclusion Criteria:

* Children with known liver disease prior to the suicide attempt.
* If a child have several suicide attempts during the inclusion-period, only the 1st will be included.
* Suicide attempts with other agents than acetaminophen.
* Children taking medication that enhance the induction of the cytochrome P450 system, increase the production of toxic metabolites, and aggravate the hepatic injury, such as ethanol, rifampin, isoniazid, barbiturates, and carbamazepine, will be excluded.

Primary outcomes:
measure: Early predictors of hepatic injury
timeFrame: 2 years
Secondary outcomes:
measure: Expression of CYP 1A2 in a pediatric population
timeFrame: 2 years
measure: Characteristics, social behaviour, trends and risk factors
timeFrame: 2 years
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
Study officials:
References: