To assess the effect of oral gabapentin versus oral acetaminophen on controlling of pain after chest tube insertion
Design
This is a double-blind randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the drawing of lots to the intervention and control groups
Settings and conduct
This study will be performed in the Besat Hospital in Hamadan city on 60 eligible candidates for chest tube insertion. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Candidate for chest tube insertion
Exclusion criteria:
Pregnancy
Body mass index greater than 30
Receiving opioid medications
Addiction to opium
Renal of liver failure
Intervention groups
Intervention group:
Oral gabapentin tablet 1200 mg one hour before chest tube insertion and then 600 mg three times daily for at most one week
Control group:
Oral acetaminophen tablet 1000 mg one hour before chest tube insertion and then 1000 mg three times daily for at most one week
Main outcome variables
Primary outcome:
Pain healing
Secondary outcome:
Possible cardiopulmonary complication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N429
Registration date:2022-05-23, 1401/03/02
Registration timing:prospective
Last update:2022-05-23, 1401/03/02
Update count:0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-08-24, 1401/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral gabapentin versus oral acetaminophen on controlling of pain after chest tube insertion: a double-blind randomized clinical trial
Public title
Effect of oral gabapentin versus oral acetaminophen on controlling of pain after chest tube insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Candidate for chest tube insertion
Exclusion criteria:
Pregnancy
Body mass index greater than 30
Receiving opioid medications
Addiction to opium
Renal of liver failure
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention.. Thus, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-05-07, 1401/02/17
Ethics committee reference number
IR.UMSHA.REC.1401.126
Health conditions studied
1
Description of health condition studied
Pneumothorax
ICD-10 code
J93.11
ICD-10 code description
Primary spontaneous pneumothorax
Primary outcomes
1
Description
Pain healing
Timepoint
Immediately after chest tube insertion and 12, 24, 48, and 72 hours after that
Method of measurement
Using Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Possible cardiopulmonary complication
Timepoint
Immediately after chest tube insertion and 12, 24, 48, and 72 hours after that
Method of measurement
With taking history and clinical examination
Intervention groups
1
Description
Intervention group: Oral gabapentin tablet 1200 mg one hour before chest tube insertion and then 600 mg three times daily for at most one week
Category
Treatment - Drugs
2
Description
Control group: Oral acetaminophen tablet 1000 mg one hour before chest tube insertion and then 1000 mg three times daily for at most one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Dr Mehrshad Sedigh
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
mehrshadsedigh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mehrshad Sedigh
Position
Resident of Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mehrshadsedigh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Hamid Rea Khorshidi
Position
General Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
khorshidi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available