Comparison of Mefenamic Acid effect in Combination with Paracetamol and Ketorulac containing pain pump on analgesia after cesarean section
Design
Phase 2-3 clinical trial with control group; sample size of 60; community based and pragmatic; with parallel, not-blinded, randomized with random blocks (6 blocks of 10).
Settings and conduct
Supportive cares; Ali-ebn Abi-Talib hospital in Zahedan
Participants/Inclusion and exclusion criteria
Inclusion criteria: elective cesarean section; first or repeated caesarean section; term pregnancy; ASA Class I & II; spinal anesthesia
Exclusion criteria: drug abuse; hemorrhagic disorders; severe psychiatric disorders; gastrointestinal disorders; Grade 2 obesity (with a BMI higher than 35); general anesthesia; preeclampsia; the presence of adhesion during surgery; prolongation of operation; massive intraoperative bleeding.
Intervention groups
The intervention group (M) will receive mefenamic acid capsule 250 mg orally two times before the onset of the spinal anesthesia and 6 hours later with an intravenous PCA pain control pump containing 35 mg per kg paracetamol and one milligram per kilogram of ketorolac at a rate of injection of 4 ml per hour. Control group (C) will receive placebo with same shape of mefenamic acid two times before the onset of the spinal anesthesia and 6 hours later with an intravenous PCA pain control pump containing 35 mg per kg paracetamol and one milligram per kilogram of ketorolac at a rate of injection of 4 ml per hour.
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180523039812N1
Registration date:2018-06-18, 1397/03/28
Registration timing:registered_while_recruiting
Last update:2018-06-18, 1397/03/28
Update count:0
Registration date
2018-06-18, 1397/03/28
Registrant information
Name
Iman Abili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5721
Email address
dr.abili@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-12, 1396/03/22
Expected recruitment end date
2018-07-13, 1397/04/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Mefenamic Acid Effect in combination with Paracetamol and Ketorolac containing Pain Pump on Analgesia after cesarean section
Public title
Effect of mefenamic acid on analgesia after cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elective cesarean section
First or repeated caesarean section
Term pregnancy
ASA Class I & II
Spinal anesthesia
Exclusion criteria:
Substance abuse
bleeding disorders
Severe psychiatric disorders
Gastrointestinal disorders
Obesity grade 2 (with a BMI greater than 35)
General anesthesia
Preeclampsia
The presence of adhesion during surgery
Prolongation of operation
Massive bleeding during surgery
Age
From 18 years old to 38 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks; Individuals; Random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Campus of the University of Medical Sciences, Dr.Hesabi Sq., Daneshgah Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-06-12, 1396/03/22
Ethics committee reference number
IR.ZAUMS.REC.1396.55
Health conditions studied
1
Description of health condition studied
Post-caesarean section analgesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity
Timepoint
6, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
Sedation
Timepoint
6, 12 and 24 hours after surgery
Method of measurement
Ramsay sedation scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving Mefenamic acid capsule (al-Hawi, Iran) orally 250 mg two times before the start of the spinal anesthesia and 6 hours later with an intravenous PCA pain control pump containing 35 mg per kg paracetamol and one milligram per kilogram of ketorolac at a rate of injection of 4 ml per hour.
Category
Treatment - Drugs
2
Description
Control group: receiving placebo with same shape of Mefenamic acid two times before the start of the spinal anesthesia and 6 hours later with an intravenous PCA pain control pump containing 35 mg per kg paracetamol and one milligram per kilogram of ketorolac at a rate of injection of 4 ml per hour.