The effect of oral midazolam in relieving pain in the patients who need insertion of nasogastric tube(NGT);
Determining and comparing the pain amount in time of NGT insertion in two groups with receiving midazolam and placebo;
Determining and comparing the satisfaction in time of NGT insertion in two study groups;
Design
Study of randomised clinical trial with control group; parallel group; triple blind;
Patients are divided into two groups according to a randomized computer program and then divided into case and control groups.
Settings and conduct
Triple blind researches being carried out on the patients referred to the emergency department of zanjan Mousavi and Valiasr Hospitals, which require the insertion of NGT.Twenty minutes before the insertion of the NGT, low dose of sedation (2milligram) syrup midazolam will give to the first group and the same amount of placebo syrup will be given to second group. The syrup is presented with encoding. The person who inserts NGT and Evaluator are not aware about drug type.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 till 60 years old;pregnancy; breastfeeding; chronic obstructive pulmonary disease;decrease level of consciousness; vomiting;benzodiazepine allergy; weight below 40 kilogram; benzodiazepine contraindications;
Intervention groups
200 patients are divided into 2 groups. Twenty minutes before the insertion of NGT, low dose of sedation ( 2 milligram) syrup midazolam will give to the first group and the same amount of placebo syrup will be given to second group. outcomes will be observed
Main outcome variables
Evaluation of pain severity based on visual analog scale;
Evaluation of patients satisfaction of nasogastric tube insertion;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110629006922N4
Registration date:2019-05-28, 1398/03/07
Registration timing:retrospective
Last update:2019-05-28, 1398/03/07
Update count:0
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Afsaneh Karami
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1727 0801
Email address
rastin@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2019-05-20, 1398/02/30
Trial completion date
2019-05-20, 1398/02/30
Scientific title
Effect of Oral Midazolam in Pain relief of patients need Nasogastric Tube insertion:A Clinical Trial Study
Public title
Effect of Oral Midazolam in Pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with age 18 - 60 years
Indication for Nasogatric tube insertion ( treatment - diagnostic)
Exclusion criteria:
decrease level of consciousness
allergy to benzodiazepines
difficulty of swalloing
nausea or vomiting
chronic obstructive pulmonary disease
pregnancy
breastfeeding
hypotension ( systolic blood pressure below 90 )
Dissatisfied to participate in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into 2-person blocks based on a Random Software Allocation Software (RAS) program, then the two case groups (Midazolam receiving group) and the control group (the group receiving the placebo) will be defined in the software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients are randomly divided into two groups based on RAS software. Prepared syrups with the dosage calculated from midazolam and placebo were delivered to the person responsible for the NG Tube and will be administered orally, 20 minutes before the procedure, with a mild administration dose (2 mg).
Containers containing midazolam and placebo are pre-coded so that the relevant assistant, patient and NG Tube employs the contents of the dishes. And the placebo is used in terms of color, odor, and appearance of the drug.
Placebo
Used
Assignment
Parallel
Other design features
Due to the presence of pain during insertion of NG Tube and its intolerance in many patients, and the lack of a positive clinical response to thrombocytopenia with lidocaine, as well as the side effects and limitations related to intravenous ketamine and midazolam, we decided This study was conducted to evaluate the effects of oral midazolam in relieving pain in patients requiring ease of administration of NG Tube.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Effect of oral midazolam on Reduce pain in the time of nasogastric insertion
ICD-10 code
Y47
ICD-10 code description
Sedatives, hypnotics and antianxiety drugs
Primary outcomes
1
Description
Pain sensation in visual analog score
Timepoint
Time of nasogastric insertion
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Satisfaction with Nasogastric tube insertion
Timepoint
After nasogastric tube insertion
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Intervention group: Midazolam receiving group; Midazolam syrup, which was made by professors of Pharmacology Department of Tabriz University of Medical Sciences. This syrup is given orally to a patient at a dose of 2 mg 20 minutes before the nasogastric tube is inserted. After insertion, it will be questioned about the severity of pain and the satisfaction of the insertion of this tube.
Category
Treatment - Drugs
2
Description
Control group: Group receiving placebo. Placebo syrup was also made by professors of the Pharmacology Department of Tabriz University of Medical Sciences. The placebo syrup is quite similar to midazolam and its mode of administration is similr midazolam. This syrup is given orally to a patient at a dose of 2 mg 20 minutes before the nasogastric tube is inserted. After insertion, it will be questioned about the severity of pain and the satisfaction of the insertion of this tube.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department of Educational & Therapeutic Hospital of Valiasr; Zanjan
Full name of responsible person
Ala Rastin
Street address
Zanjan; Valiasr Square; Sheikh Fazlollah Noori Highway; Valiasr Medical Education Center
City
Zanjan
Province
Zanjan
Postal code
4515777977
Phone
+98 24 3377 0801
Fax
+98 24 3377 0757
Email
ala.rastin@gmail.com
Web page address
http://zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Deputy of Research and Technology; University of Medical Sciences; Azadi Square; Zanjan; Iran
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3342 0651
Email
dr.akarami@yahoo.com
Web page address
http://zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is 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
The whole data after Unidentifiable of patients, will be converted into the article and we try to published it in a reliable Journal
When the data will become available and for how long
All data will be released without time limitation.
To whom data/document is available
Results will be available for all groups.
Under which criteria data/document could be used
Data will be available to interested researchers without limitations.
From where data/document is obtainable
In order to receive the dataو during communication with the responsible scientific officer, the requested information will be provided to the applicants through his email.
What processes are involved for a request to access data/document
With request for Information, it will be sent by email as soon as possible.