Respiratory adverse events in children with mild upper respiratory infection: intravenous corticosteroid compared to placebo, randomized blinded clinical trial
Patients: Two hundered pediatric patients (1-6 Y), candidate for ophthalmology examination under anesthesia (which cannot be postponed for 6 weeks) with mild upper respiratory tract infection (URI) (based on Parnis criteria) are enrolled.
Intervention: After taking written informed consent from parents or gaurdians, they are randomized to blindly receive intravenous corticosteroid (group c) or placebo (group P), ten minutes before anesthesia. Same protocol of anesthesia with sevoflurane and LMA were conducted for both groups.
Inclusion criteria would be as follow:1- recent (started within two week) upper respiratory infection (URI).2- Mild URI (based on Parnis criteria). 3- anesthesia could not be postponed for 6 weeks later. 4- ASA class II and exclusion criteria as follow: 1- Difficult airway. 2- Cardiac condition. 3- Drug allergy. 4- Change in surgery or anesthesia plan (more drug prescriptions other than protocol) 5- long lasting surgery (more than an hour)
Measurement: Perioperative outcomes (cough. desaturation, laryngospasm, bronchospasm vomiting and re-admission to hospital for respiratory problems) were assessed in recovery and 7 days later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307023436N2
Registration date:2013-07-18, 1392/04/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-18, 1392/04/27
Registrant information
Name
Babak Gharaei
Name of organization / entity
Labbafijejad Hospital, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2254 9029
Email address
b.gharaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Anesthesiology Department of Labbafinejad Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2013-08-03, 1392/05/12
Expected recruitment end date
2014-02-03, 1392/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Respiratory adverse events in children with mild upper respiratory infection: intravenous corticosteroid compared to placebo, randomized blinded clinical trial
Public title
Is corton beneficial for pediatric patients with coryza undergoing anesthesia?
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion:1- recent (started within two week) upper respiratory infection (URI).2- Mild URI (based on Parnis criteria). 3- anesthesia could not be postponed for 6 weeks later. 4- ASA class II
Exclusion: 1- Difficult airway. 2- Cardiac condition. 3- Drug allergy. 4- Change in surgery or anesthesia plan (more drug prescriptions other than protocol) 5- long lasting surgery (more than an hour)
Age
From 1 year old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak St
City
Tehran
Postal code
Approval date
2012-12-10, 1391/09/20
Ethics committee reference number
400/8641
Health conditions studied
1
Description of health condition studied
Acute Nasopharyngitis
ICD-10 code
J00
ICD-10 code description
Coryza (acute)Nasal catarrh, acuteNasopharyngitis
Primary outcomes
1
Description
Cough
Timepoint
(after intervention) Recovery, and 7 days later
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Desaturation (SPO2 less than 92%)
Timepoint
(after intervention) Induction, Maintenance, Emergence and Recovery
Method of measurement
Continious pulse oximetry
2
Description
Partial Laryngospasm (inspiratory stidor)
Timepoint
(after intervention) Induction, maintenance, Emergence and Recovery
Method of measurement
Continious observation
3
Description
Bronchospasm (expiratory wheeze)
Timepoint
(after intervention) Induction, maintenance, emergence and recovery
Method of measurement
Lung auscultation
4
Description
Vomiting
Timepoint
(after intervention) Induction, maintenance, emergence and recovery
Method of measurement
Observation
5
Description
Re-admission within a week after discharge (respiratory related)
Timepoint
(after intervention) 7 days after anesthesia
Method of measurement
Telephone asking
Intervention groups
1
Description
Intervention:
Intravenous Hydrocortisone (1mg/kg) and dexamethasone slow iv injection (0.1 mg/kg) , ten minutes before anesthesia
Category
Prevention
2
Description
Control:
Intravenous normal sailine with same volume injected in the intervention group