The effects of Melatonin, Gabapentin and Dextromethorphan on post operative pain control in patients undergoing hip fracture surgery with general anesthesia
The effects of Melatonin, Gabapentin and Dextromethorphan on post operative pain control in patients undergoing hip fracture surgery with general anesthesia
Design
This double-blind and clinical trial .120 patients who are candidate for hip bone surgery at Valiasr Hospital in Arak. We will divide patients in 4 groups by simple randomization. Groups are parallel.
Settings and conduct
This double-blind and clinical trial .120 patients who are candidate for hip bone surgery at Valiasr Hospital in Arak.The patients are divided into 4 groups by simple randomization with envelopes.The study is double-blind.Outcome elevator and analyzer and participant are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria:Candidate for hip fracture surgery, 17 to 65 years old, both sexes ,absence of fractures in other organs ,absence of coagulation disorders, lack of renal and hepatic and cardiovascular disease, no history of drug use in the past 48 hours, no drug and psychotropic addiction and alcohol
Exclusion criteria:Unwillingness to participate in the study, severe hemodynamic instability
Intervention groups
Intervention group 1: We treat patients with 6 milligram Melatonin sublingual (Webber Natural.Canadian Co.) dissolved in water (final volume is 5 millimeter ) 90 minute before surgery.
Intervention group 2: We treat patients with 1 milligram in kilogram oral Dextromethorphan (Porcina Pharmaceutical Co. Iran)dissolved in water (final volume is 5 millimeter ) 90 minutes before surgery.
Intervention group 3: We treat patients with 600 milligram tablet of Gabapantin (Tehran shimi Co. Iran)dissolved in water (final volume is 5 millimeter ) 90 minutes before surgery.
Control group:We treat patients with 5 millimeter distilled water orally 90 minutes before surgery.
Main outcome variables
Pain, sedation, mean opiate drug use
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N136
Registration date:2020-03-13, 1398/12/23
Registration timing:registered_while_recruiting
Last update:2020-03-13, 1398/12/23
Update count:0
Registration date
2020-03-13, 1398/12/23
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Melatonin, Gabapentin and Dextromethorphan on post operative pain control in patients undergoing hip fracture surgery with general anesthesia
Public title
The effects of Melatonin, Gabapentin and Dextromethorphan on post operative pain control in patients undergoing hip fracture surgery with general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for hip fracture surgery
17 to 65 years old
Both sexes
Absence of fractures in other organs
Absence of coagulation disorders
Lack of renal and hepatic and cardiovascular disease
No history of drug use in the past 48 hours
No drug and psychotropic addiction and alcohol
Exclusion criteria:
Unwillingness to participate in the study
Severe hemodynamic instability
Age
From 17 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in 4 groups A and B and C and D .
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-01-12, 1398/10/22
Ethics committee reference number
IR.ARAKMU.REC.1398.286
Health conditions studied
1
Description of health condition studied
Hip fracture surgery
ICD-10 code
S32.4
ICD-10 code description
Fracture of acetabulum
Primary outcomes
1
Description
Pain
Timepoint
At recovery time, 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Visual analog scale
2
Description
Sedation
Timepoint
24 hours after surgery
Method of measurement
Ramsy score
3
Description
Mean of opiate drug
Timepoint
24 hours after surgery
Method of measurement
Milligram
4
Description
Mean blood pressure
Timepoint
Every 15 minutes during surgery and recovery time
Method of measurement
Barometer
5
Description
Mean heart rate
Timepoint
Every 15 minutes during surgery and recovery time
Method of measurement
Count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: We treat patients with 6 milligram Melatonin sublingual (Webber Natural.Canadian Co.) dissolved in water (final volume is 5 millimeter ) 90 minute before surgery.
Category
Treatment - Drugs
2
Description
Intervention group 2: We treat patients with 1 milligram in kilogram oral Dextromethorphan (Porcina Pharmaceutical Co. Iran)dissolved in water (final volume is 5 millimeter ) 90 minutes before surgery.
Category
Treatment - Drugs
3
Description
Intervention group 3: We treat patients with 600 milligram tablet of Gabapantin (Tehran shimi Co. Iran)dissolved in water (final volume is 5 millimeter ) 90 minutes before surgery.
Category
Treatment - Drugs
4
Description
Control group:We treat patients with 5 millimeter distilled water orally 90 minutes before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street