Effectiveness of oral administration of meloxicam with pain pump containing paracetamol and sufentanil on analgesia after cesarean section
Design
The control group consisted of patients receiving placebo in the form of oral meloxicam at a dose of 7.5 mg two times before the onset of the spinal anesthesia and 12 hours later with a pain control pump
Settings and conduct
Ali ebn Abi Talib hospital in Zahedan, not blinded clinical trial controlled with placebo, randomized blocking
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 18 to 38 years; term pregnancy; elective cesarean; ASA class one and two. Exclusion criteria: drug abuse; bleeding disorders; severe psychiatric disorders; body mass index higher than 35; preeclampsia
Intervention groups
The intervention group included patients receiving meloxicam tablets (Hexal, Germany) orally at a dose of 7.5 mg two times before the onset of spinal anesthesia and 12 hours later with a pain control pump
Main outcome variables
Pain intensity; need for analgesic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180206038648N1
Registration date:2018-02-23, 1396/12/04
Registration timing:registered_while_recruiting
Last update:2018-02-23, 1396/12/04
Update count:0
Registration date
2018-02-23, 1396/12/04
Registrant information
Name
Saman Nasrollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5778
Email address
dr.nasrollahi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-26, 1396/04/05
Expected recruitment end date
2018-06-26, 1397/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of oral meloxicam with paracetamol and sufentanil pain pump in analgesia after cesarean section
Public title
Efficacy of oral meloxicam in analgesia after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elective cesarean section
Term pregnancy
ASA Class I & II
Exclusion criteria:
Drug abuse
Bleeding disorders
Severe psychiatric disorders
Body mass index higher than 35
Preeclampsia
Age
From 18 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random Blocks
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Ali-ebn Abi Talib Hospital, Salamat Blvd., Daneshgah Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Approval date
2017-06-25, 1396/04/04
Ethics committee reference number
IR.ZAUMS.REC.1396. 74
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
Pain intensity
Timepoint
6,12, and 24 hours after surgery
Method of measurement
VAS (Vision Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: administration of the meloxicam tablet (Hexal, Germany) orally at a dose of 7.5 mg two times before the onset of the spinal anesthesia and 12 hours later
Category
Treatment - Drugs
2
Description
Control group: administration of a meloxicam-like tablet placebo two times before the onset of spinal anesthesia and 12 hours later.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-ebn Abi Talib Hospital
Full name of responsible person
Saman Nasrollahi
Street address
Ali-ebn Abi Talib Hospital, Salamat Blvd., Daneshgah Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
dr.nasrollahi@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Mohsen Tahri
Street address
Hesabi Sq., Daneshgah Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
dr.taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Saman Nasrollahi
Position
Anesthesia resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ali-ebn Abi Talib Hospital, Salamat Blvd., Daneshgah Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
dr.nasrollahi@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Jamshid Ordoni Aval
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ali eb abi Talib Hospital, Salamat Blvd., Daneshgah Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
dr.ordoniaval@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Saman Nasrollahi
Position
Anesthesia resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ali ebn Abi Talib Hospital, Salmat Blvd., Daneshgah Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
dr.nasrollahi@zaums.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