Efficacy of Intra nasal naloxone on respiratory rate,consciousness and O2Saturation in opium poisoning in children
Design
Patients with inclusion criteria divided into 2 groups alternately;
Intra nasal naloxone dribbling(case ) group and Intra venous naloxone injection(control) group .
There is no randomization.
Settings and conduct
Patients 1-13 years-old with opium poisoning referred to Loghman-Hakim hospital poison center treated with
Intranasal naloxone dribbling in one patient and Intravenous naloxone injection in the next one .
Participants/Inclusion and exclusion criteria
One year to 13 years
Opium poisoning
No nasal congestion
Parental agreement
No history of Cardiopulmonary arrest,Coma,Apnea.
Intervention groups
Intranasal naloxone dribbling for patients as case group and Intravenous Naloxone injection for the next one as control group.
Main outcome variables
Respiratory Rate;O2 Saturation;Level of conscienceness(Glasgow Coma Scale) GCS.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180226038869N1
Registration date:2019-02-22, 1397/12/03
Registration timing:registered_while_recruiting
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
Fariba Farnaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5102 5000
Email address
faribafarnaghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intranasal versus Intravenous Naloxone in opium poisoning in children.
Public title
Intranasal naloxone for treatment of opioid poisoning in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Opium poisoning
1-13 years
No nasal congestion
Parental agreement
Exclusion criteria:
Age
From 1 year old to 13 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Lack of enough evidence for IN naloxone in treatment of opiod poisoning in children
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences