Objectives:
Tonsillectomy is one of the most common pediatric surgeries and post-operation pain is an important complication of this surgery. The aim of this study is to compare the effect of Lidocaine-Morphine and Lidocaine-Ketamine spray on post-tonsillectomy pain in children.
Design:
In this clinical trial, 120 children who are candidate for elective tonsillectomy will be randomly divided into one of the three groups of Lidocaine-Morphine or Lidocaine–Ketamine or control (placebo) (each group has 40 participants).
Setting and conduct:
After induction of general anesthesia and intubation, the operation will be performed (the same rule for all patients). At the end of surgery, we use handmade Lidocaine-Morphine spray for Lidocaine-Morphine group, handmade Lidocaine–Ketamine spray for Lidocaine–Ketamine group and handmade normal saline spray as placebo for control group (locally at the operation site). After extubation when patients enter the recovery ward, until one hour, their pain will be assessed subjectively by an unaware person with FLACC Pain Scaling System. In the case of more than 4 scores for post-operation pain, one dose of Petedine (0/5 mg/kg) will be injected intravenously.
Major Inclusion and Exclusion criteria:
6 to 12 years old children who are candidate for elective tonsillectomy without history of asthma or allergy to morphine or lidocaine or recent usage of analgesics.
Intervention:
Usage of Lidocaine-Morphine spray, Lidocaine–Ketamine spray or normal saline spray.
Main outcome measures (variables):
Finally the scores of pain of all groups’ participants will be compared to each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111019037N4
Registration date:2014-11-17, 1393/08/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-17, 1393/08/26
Registrant information
Name
Mahdieh Yousef-Zanjani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6004
Email address
yusefi.mahdieh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Lidocaine-Morphine and Lidocaine-Ketamine Spray on Post-Tonsillectomy Pain in Children
Public title
Comparison of the Effect of Lidocaine-Morphine and Lidocaine-Ketamine Spray on Post-Tonsillectomy Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
6 to 12 years old children who are candidate for elective tonsillectomy.
Exclusion criteria:
Patients who usually use anticonvulsants or analgesics or anti-inflammatory agents; patients with history of allergy to morphine or lidocaine; patients with underline diseases like asthma.
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The children who enter this trial will be randomly selected for each groups by colored cards.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin university of medical sciences
Street address
Shahid Bahonar Boulevard
City
Qazvin
Postal code
Approval date
2014-06-12, 1393/03/22
Ethics committee reference number
28.20.8849
Health conditions studied
1
Description of health condition studied
Pain in throat (surgery site)
ICD-10 code
R07.0
ICD-10 code description
Pain in throat
Primary outcomes
1
Description
Post-operation pain
Timepoint
From the enterance to the recovery ward until one hour (every 20 minutes)
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group:
Local usage of handmade Lidocaine-Morphine spray (including Lidocaine 10% spray from Irandarou manufacturing company, Tehran, Iran, registered No. 1228129223 and Morphine 10mg/ml ampule from Daroupakhsh manufacturing company, Tehran, Iran, registered No. 1228081477): 1puff/8kg on tonsillectomy site. Each puff: 0.1mg Lidocaine + 0.05mg Morphine.
Category
Treatment - Drugs
2
Description
Second intervention group:
Local usage of handmade Lidocaine-Ketamine spray (including Lidocaine 10% spray from Irandarou manufacturing company, Tehran, Iran, registered No. 1228129223 and Ketamine 50mg/ml ampule from Rotexmedica manufacturing company, Germany, registered No. 1228070822): 1puff/8kg on tonsillectomy site. Each puff: 0.1mg Lidocaine + 0.05mg Ketamine.
Category
Treatment - Drugs
3
Description
Third intervention group:
Local usage of handmade normal saline spray (including normal saline solution 9mg/ml from Daroupakhsh drug manufacturing company, Tehran, Iran, registered No. 1228057458): 1puff/8kg on tonsillectomy site.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods Pediatrics Hspital
Full name of responsible person
Dr. Abbas Hosseini-Jahromi
Street address
Qods Square
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Ardalan Samadzadegan
Street address
Qods Pediatrics Hspital
City
Qazvin
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Ardalan Samadzadegan
Position
Anesthesiology
Other areas of specialty/work
Street address
Qods Pediatrics Hospital, Qods Square
City
Qazvin
Postal code
Phone
00
Fax
Email
yusefi.mahdieh@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)