Protocol summary

Study aim
Comparison of effect of intravenous administration of ketorolac and acetaminophen (Apotel) on pain relief after uvulopalatopharyngoplasty(UPPP) surgery
Design
Referees for Uvulopalatopharyngoplasty surgery were divided into two groups based on the random numbers table. To the first group, Ketorolac 0.5 milligram/kilogram (maximum dose 30 milligram) was given intravenously half an hour before the end of surgery and then every 8 hours to 24 hours, and in the second group, acetaminophen (Apotel) 15 milligram/kilogram (maximum dose 1 gram) half an hour. Before the end of surgery and then 1 gram was prescribed every six hours for 24 hours. Then the pain level was evaluated based on Visual Analogue Scale (VAS) at half, 6, 12, 24 and 48 hours after surgery. The time to start swallowing liquids and solids was compared between the two groups.
Settings and conduct
patients aged 18-55 who had referred to ShahidSadoughi Hospital for the treatment of obstructive sleep apnea by UPPP
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients with ASA 1 and 2, body mass index˂35. Exclusion criteria were any heart disease, uncontrolled blood pressure, uncontrolled diabetes, gastrointestinal problems, including (GERD), patient non-cooperation, use of anticoagulant drugs, drug abuse, use of corticosteroids, kidney disease, and surgery length of more than 2 hours.
Intervention groups
To the first group, 0.5 milligram/kilogram (maximum dose 30 mg) of intravenous ketorolac half an hour before the end of surgery and then every 8 hours to 24 hours after surgery, and to the second group, acetaminophen (Apotel) 15 milligram/kilogram (maximum dose 1 gram) ) was administered half an hour before the end of surgery and then 1 gram every six hours until 24 hours.
Main outcome variables
intensity of pain need for drugs Time to start swallowing liquids Time to start swallowing solids

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240402061399N1
Registration date: 2024-04-09, 1403/01/21
Registration timing: prospective

Last update: 2024-04-09, 1403/01/21
Update count: 0
Registration date
2024-04-09, 1403/01/21
Registrant information
Name
Maryam Bahaloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3826 9200
Email address
drbahaloo@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-05-30, 1403/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of intravenous administration of ketorolac and acetaminophen on pain relief after Uvulopalatopharyngoplasty surgery
Public title
A comparative study of the effect of intravenous administration of ketorolac and acetaminophen on pain relief after Uvulopalatopharyngoplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with american society of anesthesiologists physical status classification(ASA) BMI˂35
Exclusion criteria:
heart disease uncontrolled hypertension uncontrolled diabetes gastrointestinal disease, Gastroesophageal reflux disease (GERD) Patient non-cooperation anti coagulant usage drug abuse corticosteroid usage renal disease surgery time more than 2 hr
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Among the 60 patients who come for this surgery during this period, we want to select two groups of 30 people for interventions. First, we consider the numbers 1 to 60. In the table of random numbers, the two digits on the left side of each number are used as the decision criterion, and after selecting the numbers randomly from the table, according to the contract, even numbers will be placed in the ketorolac intervention group and odd numbers will be placed in the acetaminophen intervention group. ,
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants are unaware of the type of drug received. The drugs of both groups are prepared by the resident and will be available to the anesthetist in the operating room and the nurses in the ENT department. The follow-up person in the operating room and ENT department is unaware of which group each person is in. The data will be coded based on the number and the person analyzing will not know about the groupings.
Placebo
Not used
Assignment
Parallel
Other design features
Ethics permission was obtained from the regional ethics committee at Shahid Sadoughi University of Medical Sciences, Yazd. code: IR.SSU.MEDICINE.REC.1402.252

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee at Shahid Sadoughi University of Medical Sciences, Yazd.
Street address
baharan jadid apartment, bahar ave, daneshgah blvd, safaeeyeh, yazd
City
yazd
Province
Yazd
Postal code
8915838795
Approval date
2023-11-08, 1402/08/17
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.252

Health conditions studied

1

Description of health condition studied
Uvulopalatopharyngoplasty
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain intensity, need for narcotics, time to start swallowing liquids, time to start swallowing solids
Timepoint
Number of times the need for narcotics during the first 48 hours after surgery, time to start swallowing liquids and solids, pain intensity 6, 12, 24 and 48 hours after surgery
Method of measurement
Pain intensity based on Visual Analogue Scalescale, number of times the need for narcotics, time to start swallowing liquids and solids

Secondary outcomes

1

Description
Heart rate, blood pressure, slow bleeding, nausea, vomiting, rash, dizziness
Timepoint
Heart rate and blood pressure before and after induction of anesthesia, after extubation, 0, 15 and 60 minutes into recovery. Bleeding in the first 48 hours after surgery. Nausea, vomiting, rash and dizziness in the first 24 hours after surgery
Method of measurement
Heart rate per minute, blood pressure mm Hg. Bleeding, nausea and vomiting, rash and dizziness or not

Intervention groups

1

Description
Intervention group: 0.5 mg/kg (maximum dose 30 mg) intravenous ketorolac half an hour before the end of surgery and then every 8 hours until 24 hours after surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd
Full name of responsible person
maryam bahaloo
Street address
Shahid Qandi Boulevard- Ibn Sina Street
City
yazd
Province
Yazd
Postal code
89158 87857
Phone
+98 35 3822 4000
Email
sadoghi-hospital@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
amin salehi abarghouei
Street address
Z - Imam Hossein (a.s.) Square - Student Blvd. - Imam Reza (a.s.) Research Educational Complex
City
yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Phone
+98 35 3628 8114
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
1
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
Yazd University of Medical Sciences
Full name of responsible person
maryam bahaloo
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
baharan jadid, bahar ave, daneshgah blvd, safaeeyeh
City
yazd
Province
Yazd
Postal code
8915838795
Phone
+98 35 3826 9200
Email
drbahaloo@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
habibollah hosseini
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Islamic Republic Blvd - Mohammad Sadegh Afshar Hospital
City
yazd
Province
Yazd
Postal code
۸۹۱۷۹۴۵۵۵۶
Phone
+98 35 3515 5011
Email
drhalhosseini@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
maryam bahaloo
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
baharan jadid. bahar aven, daneshgah blvd
City
yazd
Province
Yazd
Postal code
8915838795
Phone
+98 35 3826 9200
Email
drbahaloo@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All cases will be written as clinical trial articles and published in a scientific journal
When the data will become available and for how long
unlimited
To whom data/document is available
All people who have scientific study in this field
Under which criteria data/document could be used
To help spread science and if accepted by reputable scientific journals
From where data/document is obtainable
Reputable scientific websites
What processes are involved for a request to access data/document
In addition to the article, documents can also be sent to university applicants by email
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