Evaluation of peritonsillar infiltration of Bupivacaine and Dexamethasone effect on pediatric post tonsillectomy pain reduction
Design
Single blind clinical trial, randomized with random numbers table, allocation concealment: using of Sequentially numbered, sealed, opaque envelopes, with control group, with factional groups on 70 children between ages of 4-15.
Settings and conduct
Study will be done, in surgery department of Sabzevar Heshmatie hospital. Patients who will enter in study, without awareness of which group they are attending, they will be operate. After anesthesia and 10 minutes before surgery, bupivacaine and dexamethasone will be direct injected to peritonsillar. When the operate will be ended, patients will be observed at 24 hours. During the hospitalization, the pain will be recorded three times.
Participants/Inclusion and exclusion criteria
Entry requirements:
Tonsillectomy surgery indication
Age between 4-15 years
No entry requirements:
Asthma
Chronic analgesic drugs use
Usage of analgesic drugs at 24 hours before surgery
Inability to connect with others
Chronic disease
Peritonsillar abscess history
Present upper respiratory infection
Intervention groups
Intervention group:
Patients of this group will receive Bupivacaine with Dexamethasone as a direct peritonsillar injection, before Surgery. 10 minutes later surgery will be start.
Control group:
Patients of this group will not receive Bupivacaine with Dexamethasone, before Surgery.
Main outcome variables
pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190406043179N1
Registration date:2019-08-05, 1398/05/14
Registration timing:registered_while_recruiting
Last update:2019-08-05, 1398/05/14
Update count:0
Registration date
2019-08-05, 1398/05/14
Registrant information
Name
Kaveh Ghajari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3765 7960
Email address
ghajarik90@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-21, 1398/04/30
Expected recruitment end date
2019-08-19, 1398/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of peritonsillar infiltration of Bupivacaine and Dexamethasone effect on pediatric post tonsillectomy pain reduction
Public title
Evaluation of Bupivacaine and Dexamethasone effect on Post Tonsillectomy Pain reduction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Tonsillectomy surgery indication
Age between 4-15 years
Exclusion criteria:
Asthma
Chronic analgesic drugs use
Usage of analgesic drugs at 24 hours before surgery
Inability to connect with others
Chronic disease
Peritonsillar abscess history
Present upper respiratory infection
Age
From 4 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
randomization method: Simple randomization
Randomization unit: individual
Randomization tool: with using a random numbers table
How to create a random sequence: using a random numbers table to read it from top to bottom and the even numbers belong to intervention group and the odd numbers belong to control group.
Allocation concealment:using of Sequentially numbered, sealed, opaque envelopes, In this way that the numbers obtained by the random numbers table will be written on the cards respectively. each card will be put inside sealed opaque envelopes.Then envelopes will be numbered and placed in boxes respectively. In the next stage, the patients will enter the group by taking the envelopes respectively (Preparation of the envelopes will be done by the secretary and the physician will not be informed of them).
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will not be informed about which group they are attending, until data collection will be finished.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Shahr blvd, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.MEDSAB.REC.1397.126
Health conditions studied
1
Description of health condition studied
Pediatric post tonsillectomy pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pediatric post tonsillectomy pain,
Timepoint
6, 12, 24 hours after surgery
Method of measurement
Using of Visual Pain Analog Scale by executor of plan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: there are 35 of attended patients (according to the criteria of entering the study), who they will receive Bupivacaine 5 mg (ّFrance Astra Zeneca company) with Dexamethasone (Iran Hormon company) 0.3 mg per kilogram of patient weight as a direct peritonsillar injection, before Surgery. 10 minutes later surgery will be start.
Category
Treatment - Other
2
Description
Control group: there are 35 of attended patients (according to the criteria of entering the study), who they will not receive any Bupivacaine and Dexamethasone before surgery (According to the references, if patients did not get drug, they will not harm and this is acceptable).