Acetylcysteine, also called N-acetylcysteine or NAC is the antidote for acetaminophen toxicity and it reduces morbidity and mortality following acetaminophen toxicity.Adverse drug reactions might affect therapeutic outcome or lead to treatment delay. In some countries NAC is given intravenously and in others orally. In our hospital the accepted route of administration is the intravenous route. In a previous study in our hospital, anaphylactoid reactions following intravenous NAC was found to be more than other studies, although there was no anaphylactoid shock or death. Moreover the oral route was not acceptable in patients because refractory emesis frequently leads to delayed or ineffective administration of the antidote. The longer duration of hospital stay in oral route is another factor makes our patients to accept the risk of anaphylactoid reactions than the oral administration. So we applied a new protocol using the combination therapy of both the oral and IV route for each patient and compared it with the only IV administration therapy (the accepted therapy in our hospital).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112146948N2
Registration date:2011-12-26, 1390/10/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-26, 1390/10/05
Registrant information
Name
Nastaran Eizadi-Mood
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2127
Email address
izadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-09-21, 1389/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the adverse effects of intravenous N-acetylcysteine with intravenous and oral N-acetylcystein in acetaminophen toxicity
Public title
Treatment of acetaminophen toxicity
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: Patients with acetaminophen poisoning; ingesting the toxic acetaminophen dose (≥7.5g); aged ≥ 18 years old; coming to the hospital before 8 hours after acetaminophen ingestion.
The exclusion criteria: Less than 7.5g acetaminophen ingesting; aged under 18 years old; coming to the hospital after 8 hours after acetaminophen ingestion; vomiting two times after oral NAC was given; pregnant patients; those who had risk factors for hepatic toxicity (e.g. those who had hepatic cirrhosis; chronic ethanol ingestion; usage of substances that induce cytochrome P450 enzyme activity including rifampin; phenobarbital; isoniazid; phenytoin and carbamazepine).
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2009-03-02, 1387/12/12
Ethics committee reference number
185066
Health conditions studied
1
Description of health condition studied
acetaminphen toxicity
ICD-10 code
T39.0
ICD-10 code description
Poisoning by nonopioid analgesics, antipyretics and antirheumatics (Salicylate)s
Primary outcomes
1
Description
anaphylactoid reactions
Timepoint
during NAC (N-acetylcysteine) infusion
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
The group A (only intravenous N-acetylcystein or NAC) was managed by IV NAC with 150mg/kg infused in 200cc of 5% dextrose water (5%DW) in 30 minutes, followed by a 4 hour infusion of 50mg/kg of NAC in 500cc of 5%DW and finally with a 16 hour infusion of 100mg/kg NAC in 1000cc 5%DW.
Category
Treatment - Drugs
2
Description
In group B (oral and IV NAC), oral NAC was given by 140mg/kg in 200cc of 5%DW. If vomiting occurred in any patient during one hour after the ingestion of the oral NAC then 10mg metoclopramide was given IM and the oral NAC was given with the same dose again. If there was no vomiting again then the administration of NAC was continued by IV route by 50mg/kg in 500cc of 5%DW in four hour infusion and then 100mg/kg in 1000cc of 5%DW in 16 hour infusion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor and Aliasghar Hospitals
Full name of responsible person
Nastaran Eizadi Mood
Street address
Noor and Aliasghar hospitals, Ostandari Avenue, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Nastaran Eizadi Mood
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Nastaran Eizadi Mood
Position
Associate profossor of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1668 0011
Fax
Email
izadi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Nastaran Eizadi Mood
Position
MD, PhD of toxicology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1668 0011
Fax
Email
izadi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Nastaran Eizadi Mood
Position
Associate proffosor of Isfahan University of Medical Sciences; MD, PhD of toxicology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
Fax
Email
izadi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)