Comparison of the effect of lidocaine- paracetamol with lidocaine- ketamine on post-tonsillectomy pain relief in children
Design
This study will be done in the operating room. All of the drugs solution of this study will be prepared by only one person who is aware of the study's grouping, in the Similar syringes 10 cc.
Anesthesiologist, patients, and all medical staff that will collaborate in the study will not aware of the drug allocated to each patient.
Settings and conduct
In the present double-blind clinical trial, which will be carried out in a parallel way, a total of 114 patients who will be undergoing undergo open tonsillectomy will be enrolled. Eligible patients will be randomly allocated into 3 equal A, B and C groups by block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ASA grade I or II (American Society of Anesthesiology classification), Patients between 3 and 10 years old and Patients undergoing open tonsillectomy.
Exclusion criteria: Allergy to the drugs used in the study, Positive history of Heart, kidney diseases and chronic pain and Lack of parental consent.
Intervention groups
Intervention group(A): ampoule of lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus Paracetamol 15 mg/kg . This solution will be injected to the patient 15 minutes before the surgery
Intervention group(B): ampoule of Lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus 0.25 mg/kg of ketamine. This solution will be injected to the patient 15 minutes before the surgery
Control group(C): ampoule of lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus normal saline (with the same volume of the studied drugs) is prepared as a placebo. This solution will be injected to the patient 15 minutes before the surgery.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221127056627N2
Registration date:2024-09-18, 1403/06/28
Registration timing:prospective
Last update:2024-09-18, 1403/06/28
Update count:0
Registration date
2024-09-18, 1403/06/28
Registrant information
Name
Zeinabsadat Fattahi Saravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
zefattahi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-01, 1403/07/10
Expected recruitment end date
2025-08-01, 1404/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of lidocaine- paracetamol with lidocaine- ketamine on post-tonsillectomy pain relief in children
Public title
Comparison of the effect of lidocaine- paracetamol with lidocaine- ketamine on post-tonsillectomy pain relief in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA grade I or II (American Society of Anesthesiology classification)
Patients between 3 and 10 years old
Patients undergoing open tonsillectomy
Exclusion criteria:
Allergy to the drugs used in the study
significant cognitive impairment in children
Positive history of Heart, kidney diseases and chronic pain.
Lack of parental consent
Age
From 3 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into three groups by block randomization. In this technique, a permutation block of size 6 will be made for patients of three groups A, B and C. In each block, equal numbers for three groups will be considered in alternative positions. Then 19 blocks of size 6 will be selected randomly and
patients will be allocated randomly and equally into three groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs are provided in the form of similar 10 cc syringes by the first person, these drugs, which have the same color and size and in similar colors, are injected by the second person who is completely unaware of the contents of the syringes. The anesthesiologist, patients, and other personnel involved in the work are blinded to the drugs injected in this study. This study is double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School.
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
197871345
Approval date
2024-03-05, 1402/12/15
Ethics committee reference number
IR.SUMS.MED.REC.1403.036
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
J35.01
ICD-10 code description
Chronic tonsillitis
Primary outcomes
1
Description
Pain after surgery
Timepoint
15, 30 and 45 minutes after surgery in recovery.
Method of measurement
Wong-Baker Pain Scale.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group(A): After selection of target group, ampoule of lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus Paracetamol 15 mg/kg .This solution will be injected intravenously to the patient 15 minutes before the start of surgery by angioket number (22-24).
Category
Treatment - Drugs
2
Description
Intervention group(B): After selection of target group, ampoule of Lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus 0.25 mg/kg of ketamine . This solution will be injected intravenously to the patient 15 minutes before the start of surgery by angioket number (22-24).
Category
Treatment - Drugs
3
Description
Control group: After selection of target group, ampoule of lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus normal saline (with the same volume of the studied drugs) is prepared as a placebo. This solution will be injected intravenously to the patient 15 minutes before the start of surgery by angioket number (22-24).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital
Full name of responsible person
Mahsa, Jalilpour aghdam
Street address
Hafez St, Shiraz.
City
Shiraz
Province
Fars
Postal code
7145683769
Phone
+98 71 3228 8064
Email
dastlib2@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
hashempur@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Jalilpoura gdam
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street