Protocol summary
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Study aim
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The goal of this study is to evaluate the effect of a single 100mg dose of Sumatriptan administered prior to surgery on acute pain after rhinoplasty during 24 hours following the operation
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Design
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In this study, which is a randomized, double-blinded, placebo-controlled clinical trial, volunteers for rhinoplasty who will enter the trial by signing a written consent, will be randomly divided into two groups, case and control; and pain intensity in both groups will be monitored in 2, 4, 6, 12 and 24 hours after surgery.
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Settings and conduct
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This is a trial conducted in Imam-Khomeini Hospital at Kermanshah University of Medical Sciences, Kermanshah, Iran. All patients, physicians, surgeons, examiners and operators are blinded to patient allocation to the study groups in this trial.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: adult volunteers for rhinoplasty with ASA I status. Exclusion criteria: any history of past or present systemic diseases; hypersensitivity to Triptans, performing any other surgery at the same time as rhinoplasty; patients’ unwillingness to stay in the trial at any time.
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Intervention groups
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volunteers for a rhinoplasty who will enter the trial by signing a written consent, will be randomly divided into two groups, Sumatriptan and placebo. One hour prior to surgery, patients in the case group will receive a 100mg tablets of Sumatriptan, and patients in the control group will receive a placebo tablets.
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Main outcome variables
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Post-operative pain intensity which would have been acquired, will be compared between the two groups.
General information
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Reason for update
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end of trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191127045516N1
Registration date:
2019-12-12, 1398/09/21
Registration timing:
prospective
Last update:
2020-04-08, 1399/01/20
Update count:
1
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Registration date
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2019-12-12, 1398/09/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-07, 1398/10/17
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Expected recruitment end date
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2020-02-06, 1398/11/17
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Actual recruitment start date
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2020-01-08, 1398/10/18
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Actual recruitment end date
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2020-02-14, 1398/11/25
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Trial completion date
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2020-02-16, 1398/11/27
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Scientific title
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The Effect of a Single 100 milligram Preoperative Dose of Sumatriptan on Postoperative Pain in Rhinoplasty
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Public title
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The prophylactic effect of Sumatriptan on pain following plastic nose surgery
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Adult individuals volunteering for rhinoplasty with ASA I status.
Exclusion criteria:
History of previous or present systemic diseases
Hypersensitivity to Triptans
Undergoing other surgical operations at the same time of rhinoplasty
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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60 sealed envelopes are prepared, 30 of which contain Sumatriptan 100mg tablets and the other 30 contain placebo tablets. A pharmacist who has no role in this trial, allocates a 4 digit random code to each envelope using the random function on a scientific calculator, and each patient gets one envelope. Therefore, allocation of patients to Sumatriptan or placebo groups is accomplished by simple randomization technique.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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A pharmacist who has no part in the study, conceals the Sumatriptan and placebo tablets in sealed envelopes and generates a unique random 4 digit number for each envelope. The fact that each 4 digit number shows a Sumatriptan or placebo containing envelope is kept in an allocation chart. The pharmacist keeps the allocation chart sealed till the end of trial. Therefore, random allocation and allocation concealment is achieved for both the patients as well as the operators, examiners, surgeons and clinicians.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-11-25, 1398/09/04
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Ethics committee reference number
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IR.KUMS.REC.1398.824
Health conditions studied
1
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Description of health condition studied
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post-operative pain after rhinoplasty
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ICD-10 code
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Acute pain
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ICD-10 code description
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G89.1
Primary outcomes
1
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Description
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severity of postoperative pain
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Timepoint
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at 2,4,6,12,24 hours after the end of operation
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Method of measurement
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using the Visual Analogue Scale(VAS)
Secondary outcomes
1
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Description
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Nausea and vomiting
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Timepoint
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24 hours after surgery
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Method of measurement
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yes/no
2
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Description
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constipation
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Timepoint
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24 hours after surgery
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Method of measurement
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yes/no
3
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Description
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drowsiness
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Timepoint
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24 hours after surgery
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Method of measurement
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yes/no
4
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Description
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difficulty concentrating
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Timepoint
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24 hours after surgery
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Method of measurement
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yes/no
5
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Description
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dry mouth
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Timepoint
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24 hours after surgery
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Method of measurement
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yes/no
Intervention groups
1
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Description
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Intervention group: 1 hour prior to surgery, patients take a 100mg Sumatriptans tablets orally with 100 cc drinking water.
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Category
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Treatment - Drugs
2
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Description
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Control group: 1 hour prior to surgery, patients take a placebo tablet orally with 100 cc drinking water.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There are no further information available.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available