The effect of ondansetron on intravenous acetaminophen analgesia after pediatric adenotonsillectomy
Design
A randomized controlled clinical trial with parallel groups, three blinded, randomized
Settings and conduct
Study Location: Hamedan Besat Hospital
Procedure: Blindness in both intervention and control groups will be prescribed intravenous acetaminophen 2 minutes before surgery.
These patients will be anesthetized the day before surgery.
The surgical technique was the same in all cases.
In pain recovery, the patient's pain is measured on a CHEOPS scale
If the pain score is greater than 1 with the CHEOPS criterion, 0.25mg / kg of meperidine will be administered to the patient for analgesia and up to 0.5 mg / kg for analgesia. The time of the first analgesic application and the total dose of adjunctive analgesic will also be recorded.
In the event of nausea and vomiting, metoclopramide may be administered as an antiemetic and intravenously.
Participants/Inclusion and exclusion criteria
Healthy 1- to 3-year-old children without an underlying disease are candidates for elective adeno-tonsillectomy who will be referred to Hamadan Besat Medical Center during the study period (year 1).
Intervention groups
Intravenous ondansetron 0.1 mg / kg in 1 ml volume plus intravenous acetaminophen 1 mg / kg 2 minutes before surgery and acetaminophen suppository every 2 hours to 4 hours
Main outcome variables
Reduce the analgesic effect of acetaminophen
Increased complications after tonsillectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160508027793N1
Registration date:2019-09-12, 1398/06/21
Registration timing:registered_while_recruiting
Last update:2019-09-12, 1398/06/21
Update count:0
Registration date
2019-09-12, 1398/06/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0032
Email address
l.halimi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-15, 1398/05/24
Expected recruitment end date
2020-03-14, 1398/12/24
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2020-03-14, 1398/12/24
Trial completion date
2020-04-08, 1399/01/20
Scientific title
The effect of IV Ondansetron on analgesic effects of IV Acetaminophen after pediatric tonsillectomy: a double blinded randomized clinical trial
Public title
The IV Ondansetron on analgesic effects of IV Acetaminophen after pediatric tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria :• Age 4-5 years:
Candidate for elective adenotonsillectomy
• Parental consent•
• No history of psychiatric illness
• Do not use the apparatus 2 hours before surgery
• Insensitivity to ondansetron or acetaminophen
• No history of venous hepatic disease
Exclusion criteria:
• Failure to cooperate after initial interventions
• Failure to show proper pain level
• The patient has a decreased level of consciousness.
Age
From 3 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
53
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose we will use the Quadratic Block Randomization method. For this purpose, we provide four sheets of paper.
On the two sheets the letter I means "Intervention" and on the other two sheets the letter C means "Comparison". Mix the sheets together and place in a drawer. On referral to each eligible patient, one leaflet will be randomly drawn and based on this leaflet, whether I or C, will be assigned to one of the intervention groups receiving ondansetron and acetaminophen or a comparison of acetaminophen recipients. It should be noted that the sheets that have been drawn out will not be returned to the drawer until they have been drawn out. After randomly pulling out all four sheets of all four sheets, all the sheets are returned to the drawer again and the procedure will continue again for the next four patients until the desired sample size is reached.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In both intervention and control groups, intravenous acetaminophen will be prescribed 2 minutes before surgery, so the patient will not be informed of the prescription drug. Medications are provided by a technician so the anesthesiologist who will measure and record the outcome of the study will not be aware of the type of medication prescribed. In addition, the analyzer will not know the results of the coding of the intervention and comparison groups. Therefore, the study will be conducted in a triple blind manner.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Opposite of Mardom`s Park , Pazhuhesh crossroad
City
Hameedan
Province
Hamadan
Postal code
6517619664
Approval date
2019-08-14, 1398/05/23
Ethics committee reference number
IRCT.UMSHA.REC1398.433
Health conditions studied
1
Description of health condition studied
Chronic tonsillitis and adenoiditis
ICD-10 code
J35.0
ICD-10 code description
Chronic tonsillitis and adenoiditis
Primary outcomes
1
Description
Painless
Timepoint
15 minutes before surgery and every 6 hours to 24 hours
Four times at recovery, 6 hours, 12 hours and 24 hours after surgery
Method of measurement
ask
Intervention groups
1
Description
Intervention group: Intravenous ondansetron 0.1 mg / kg in 2 ml volume plus intravenous acetaminophen 15 mg / kg 15 minutes before surgery and acetaminophen suppository every 6 hours to 24 hours after surgery
Category
Treatment - Drugs
2
Description
Control group: Intravenous normal saline 2 ml plus acetaminophen 2 mg / kg 15 min before end of surgery and acetaminophen suppository every 6 hours to 24 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Mahshid Nikooseresht
Street address
Shahid Beheshti Blv.
City
Hamedan
Province
Hamadan
Postal code
6517619664
Phone
+98 81 3262 1515
Email
besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashiriyan
Street address
in front of Mardom's Park, Pazhuhesh Crossroad
City
Hamedan
Province
Hamadan
Postal code
6517619664
Phone
+98 81 3838 0574
Email
Medical_faculty@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?