Objectives: To evaluate the preventive effect of topical versus intravenous lidocaine on postoperative cough in children with mild upper respiratory tract infection (URI) anesthetized with laryngeal mask airway (LMA)
Inclusion: Children with mild URI aged 1-6 y undergoing anesthesia for ophthalmic examination.
Exclusion: Anesthesia lasting more than an hour or requiring extra drugs
Randomization: patients were randomized to receive intravenous vs. topical (on LMA) lidocaine while same volume of normal saline or lubricating gel was applied as placebo.
Method: 130 patients anesthetized by incremental doses of sevoflurane and received intravenous atropine (0.01 mg/kg). One group received intravenous lidocaine (1.5 mg/kg) and topical placebo on LMA. The other group received intravenous placebo and topical lidocaine. LMA was inserted in deep anesthesia. Patients received sevoflurane (3%) with N2O and O2 (50%) (While on spontaneous respiration) for maintenance and LMA removed at the end of examination in deep state.
Measurements: Cough was assessed as primary outcome while apnea, desaturation, laryngospasm, bronchospasm and readmission (one day postoperative) evaluated as secondary outcomes. Outcomes were assessed during induction, maintenance, emergence and recovery (albeit readmission was recorded one day postoperatively).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812083436N1
Registration date:2012-08-07, 1391/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-07, 1391/05/17
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
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-12-12, 1390/09/21
Expected recruitment end date
2012-05-01, 1391/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Anesthesia for the Child with Mild Upper Respiratory Tract Infection: Comparison of intravenous vs. topical lidocaine
Public title
Anesthesia for the Child with Mild Upper Respiratory Tract Infection: Comparison of intravenous vs. topical lidocaine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All pediatric patients between 1-6 y-old whose parents mentioned mild URI symptoms (nasal discharge or congestion, cough, sneeze) started within last two weeks
No evidence of bacterial infection (axillary temperature more than 38, ill appearance evaluated by anesthesiologist in charge, purulent discharge or sputum)
No evidence of lower respiratory infection (crackle or wheeze)
No evidence of medical condition (respiratory, cardiac or neurologic)
Patients candidate for anesthesia to receive full ophthalmologic examination. These procedures were necessary to perform and further delay would have deleterious consequences.
Exclusion criteria:
Those with a probable difficult airway
Hypersensitivity to drugs
Patients who received hydrocortisone, dexamethasone or extra atropine and vasopressor
Those who required muscle relaxant due to unpredicted surgery plan change
or procedures lasting 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:
130
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/Ethics Committee