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Comparing the effect of single doses of preoperative use of Sumatriptan 100 milligram, Pregabalin 75 milligram and Gabapentin 300 milligram on postoperative pain in rhinoplasty

Protocol summary

Study aim
Comparison of effectiveness of preoperative single dose of 100 mg Sumatriptan, 75 mg Pregabalin, 300 mg Gabapentin on pain after rhinoplasty
Design
The clinical trial has three double-blind, randomized, parallel groups
Settings and conduct
90 patients undergoing rhinoplasty are divided randomly into three groups of 30 patients receiving Sumatriptan, Pregabalin and Gabapentin. One hour before surgery, patients will be given the drugs orally. The severity of pain 2, 4, 6, 12, and 24 hours after surgery is measured using Visual Analog Scale (VAS). Data analysis will be done using Stata V14.2 software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adult volunteers for rhinoplasty with ASA I status Exclusion criteria: Patients with a history of substance, drug or alcohol abuse, patients with renal or hepatic failure, patients with a history of diabetes or patients with diabetes, patients with a history of allergy to any of the drugs used in this study. Patients who take anti-diabetic, antidepressant, antiepileptic or antihypertensive drugs, patients who take painkillers daily or within 24 hours before surgery, as well as patients who are unable to co-operate.
Intervention groups
Volunteers for a rhinoplasty who will enter the trial by signing a written consent, will be randomly divided into three groups: Sumatriptan, Pregabalin and Gabapentin . One hour before the surgery, patients in each group will receive a capsule which contains one of these drugs: 100 mg Sumatriptan, 75 mg Pregabalin, 300 mg Gabapentin.
Main outcome variables
Post-operative pain intensity which would have been acquired, will be compared between the three groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140503017537N7
Registration date: 2020-04-25, 1399/02/06
Registration timing: registered_while_recruiting

Last update: 2020-04-25, 1399/02/06
Update count: 0
Registration date
2020-04-25, 1399/02/06
Registrant information
Name
Hesamedin Nazari
Name of organization / entity
Kermanshah University of Medical Sciences , School of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 918 856 5291
Email address
h.nazari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-09, 1398/12/19
Expected recruitment end date
2020-05-08, 1399/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of single doses of preoperative use of Sumatriptan 100 milligram, Pregabalin 75 milligram and Gabapentin 300 milligram on postoperative pain in rhinoplasty
Public title
Comparison of the efficacy of Sumatriptan, Pregabalin and Gabapentin on postoperative pain in rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adult individuals volunteering for rhinoplasty with ASA I status.
Exclusion criteria:
Patients with a history of substance abuse, drug abuse or alcohol abuse Patients with kidney or liver failure Patients with diabetes or history of diabetes Patients who are allergic to any of the drugs used in this trial Patients who use antidiabetic medications, antidepressants, anticonvulsants or antihypertensive medications Patients who use painkillers daily or 24 hours before the surgery Patients who are unable to cooperate
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of the group they take part in. Also, the person responsible for evaluating outcomes in the patient has been kept unaware of treatment groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Committee of Ethics in Research, Kermanshah University of Medical Sciences
Street address
No. 26, Valiasr alley, Sadjad blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6718938513
Approval date
2020-02-19, 1398/11/30
Ethics committee reference number
IR.KUMS.REC.1398.1185

Health conditions studied

1

Description of health condition studied
post-operative pain after rhinoplasty
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

Primary outcomes

1

Description
Severity of postoperative pain
Timepoint
At 2,4,6,12,24 hours after the end of operation
Method of measurement
Using the Visual Analogue Scale(VAS)

Secondary outcomes

1

Description
Nausea and Vomiting
Timepoint
Within 24 hours after surgery
Method of measurement
Yes/No

2

Description
Drowsiness
Timepoint
Within 24 hours after surgery
Method of measurement
Yes/No

Intervention groups

1

Description
Intervention group1: One hour before surgery, patients receive an oral capsule containing 100 mg Sumatriptan with 100 ml of drinking water.
Category
Prevention

2

Description
Intervention group2: One hour before surgery, patients receive an oral capsule containing 75 mg Pregabalin with 100 ml of drinking water.
Category
Prevention

3

Description
Intervention group3: One hour before surgery, patients receive an oral capsule containing 300 mg Gabapentin with 100 ml of drinking water.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah Imam Khomeini Hospital
Full name of responsible person
Hamed Nazari
Street address
Imam khomeini Hospital, Naghlieh St.
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
nazari.hamed67@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice chancellor for research and technology, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3837 0541
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Hamed Nazari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shariati St
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
nazari.hamed67@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kermanshah University of Medical Sciences
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shariati St
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
nazari.hamed67@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ghazal Hemati
Position
Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shariati St
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3725 3775
Email
ghhemati@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are no further information available.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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