objective: The effect of intravenous metoclopramide on pain rate, discomfort and nausea caused by the insertion of nasogastric tube.design and setting: This study is a double blind randomized clinical trial.The target population will included all patients who need admission to hospital NG tube insertion Imam Khomeini hospital in sari.The sampling will be carried out after obtaining the necessary permits and obtaining the informed consent of patients, 46 patients needed to be elected NG tube. inclusion criteria:patient's willingness to participate in the study and obtain informed consent; Indications put nasogastric tube; Age over 18 years.exclusion criteria:Lack of patient awareness; Patients with unstable hemodynamic status; Having nosebleeds during the study period; Having problems anatomical nose; Trauma patients; Hypersensitivity to metoclopramide; Medications interact with metoclopramide; Pregnancy;patients with nausea and vomiting will ; If more than two attempts for nasogastric tube insertion is done.intervention:Intervention group, before planting NG tube, 10 mg metoclopramide (manufacturing pharmaceutical company Al-Hawi) will be given intravenously 15 minutes before the procedure. The pipeline project done by students trained and at zero, 30 and 60 minutes on the completed listadministered. Once the injection.control group, with a similar volume of saline (as a placebo) will be administered.The pipeline project done by students trained and at zero, 30 and 60 minutes on the completed list . main outcom variable: Discomfort and pain during intubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015083023696N2
Registration date:2015-12-23, 1394/10/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-23, 1394/10/02
Registrant information
Name
Seyed Mohammad Hosseininejad
Name of organization / entity
Mazandaran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3337 7169
Email address
mhoseininejad@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University Of Medical Science
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of pre-emptive metoclopramide on patients' pain, discomfort and nausea associated with NG Tube insertion
Public title
Study of anti-nausea drug metoclopramide easily nasogastric tube insertion compared with patients not receiving.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:patient's willingness to participate in the study and obtain informed consent; Indications put nasogastric tube; Age over 18 years.
exclusion criteria:Lack of patient awareness; Patients with unstable hemodynamic status; Having nosebleeds during the study period; Having problems anatomical nose; Trauma patients; Hypersensitivity to metoclopramide; Medications interact with metoclopramide; Pregnancy;patients with nausea and vomiting will ; If more than two attempts for nasogastric tube insertion is done.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random, using a list provided by the computer and statistical software, version 13 is stuta. And the block size 2 and 4 and the ratio of one to one.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University Of Medical Science
Street address
Sari, Mazandaran
City
Sari
Postal code
Approval date
2015-11-27, 1394/09/06
Ethics committee reference number
IR.MAZUMS.REC.94
Health conditions studied
1
Description of health condition studied
pain, discomfort and nausea associated with NG Tube insertion
ICD-10 code
k91.8
ICD-10 code description
Complications of action on the digestive system
Primary outcomes
1
Description
discomfort during intubation.
Timepoint
Zero minutes, 30 minutes, 60 minutes
Method of measurement
score pain, nausea, discomfort
2
Description
nausea and vomiting
Timepoint
Zero minutes, 30 minutes, 60 minutes
Method of measurement
score pain, nausea, discomfort
3
Description
pain
Timepoint
Zero minutes, 30 minutes, 60 minutes
Method of measurement
score pain, nausea, discomfort
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group, before planting NG tube, 10 mg metoclopramide (manufacturing pharmaceutical company Al-Hawi) will be given intravenously 15 minutes before the procedure. The pipeline project done by students trained and at zero, 30 and 60 minutes on the completed listadministered. Once the injection.
Category
Treatment - Drugs
2
Description
control group, with a similar volume of saline (as a placebo) will be administered.The pipeline project done by students trained and at zero, 30 and 60 minutes on the completed list .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Seyed Mohammad Hoseininejad
Street address
Mazandaran, Sari, Razi str
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University Of Medical Science
Full name of responsible person
Ahmad Ali Enayati
Street address
mazandaran-sari-meidan moalem-Vice Chancellor for Research and Technology University of Medical Sciences
City
sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University Of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran Univercity Of Medical Science
Full name of responsible person
Mohammad Hajizadeh
Position
Resident emergency Medicine
Other areas of specialty/work
Street address
Mazandaran, Sari, valiasr bolvar
City
Sari
Postal code
Phone
+1 133377169
Fax
Email
mhoseininejad@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Science
Full name of responsible person
Dr Seyed Mohammad Hoseininejad
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Mazandaran, Babol
City
Babol
Postal code
Phone
+1 133377169
Fax
Email
mhoseininejad@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Orthopedics Research Center, Mazandaran University Of Science
Full name of responsible person
Samira Aghajani
Position
Other areas of specialty/work
Street address
Mazandaran, Sari
City
Sari
Postal code
Phone
00
Fax
Email
s.aghajani5233@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)