This double-blind study aims to compare the effects of ketorolac and pethidine on pain intensity and duration of analgesia after cesarean section. A total of 102 candidates for elective caesarean section admitted to Vali-asr Hospital of Birjand will participate if they will to participate and have inclusion criteria (lack of dependency on opioids, atopy and bronchial asthma, diabetes, renal and hepatic disease, alcohol or drugs abuse, gestational hypertension, preeclampsia and peptic ulcer disease, multiple pregnancy, obesity, infant macrosomia). They will be randomly allocated into two intervention groups (n=61 per group) using simple random sampling method. One group will receive ketorolac (30 mg for those <50 kg; 60mg for those >50 kg) and the second group would have pethidine (30 mg). After 4 hours, Faces Pain Scale and Visual Analog Scale will be used to measure pain. The patients will not receive any tranquilizer during the 4 hours but 20 mg of pethidine in case of severe pain. Analgesia duration will be acknowledged by the patients during the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101317756N8
Registration date:2016-10-17, 1395/07/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-17, 1395/07/26
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery for Research, Birjand University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of ketorolac and pethidine on pain control and duration of analgesia after cesarean section
Public title
Effects of ketorolac and pethidine on pain control and duration of analgesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Candidates for elective caesarean section willing to participate; lack of dependency on opioids, atopy and bronchial asthma, diabetes, renal and hepatic disease, alcohol or drugs abuse, gestational hypertension, preeclampsia and peptic ulcer disease, multiple pregnancy, obesity, infant macrosomia; exclusion criteria: unwillingness to continue participation.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice-Chancellery of Research, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Approval date
2015-12-21, 1394/09/30
Ethics committee reference number
Ir.bums.1394.60
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Pain intensity
Timepoint
4 hours after treatment
Method of measurement
Faces Pain Scale and Visual Analog Scale (VAS)
2
Description
Anelgesic duration
Timepoint
From end of intervention until first pain onset
Method of measurement
patient self-report
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group (i.e., The Ketorolac group): Having undergone general anesthesia, they will get injected by Ketorolac (30 mg for those <50 kg; 60 mg for those >50 kg). After 4 hours, Faces Pain Scale and Visual Analog Scale will be used to measure pain. The patients will not receive any tranquilizer during the 4 hours but 20 mg of pethidine in case of severe pain. Analgesia duration will be recorded upon the patients' acknowledgement.
Category
Treatment - Drugs
2
Description
The second intervention group (i.e., The Pethadine group): Having undergone general anesthesia, they will get injected by Pethidine (30 mg). After 4 hours, Faces Pain Scale and Visual Analog Scale will be used to measure pain. The patients will not receive any tranquilizer during the 4 hours but 20 mg of pethidine in case of severe pain. Analgesia duration will be recorded upon the patients' acknowledgement.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr Hospital
Full name of responsible person
Zeinab Abbaspour Benhangi
Street address
Ghaffari St.,
City
Birjand,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellery for Reasearch at Birjand University of Medicla Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari St.,
City
Birjand,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery for Reasearch at Birjand University of Medicla Sciences
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
Birjand Univercity of Medical Sciences
Full name of responsible person
Zainab Abbaspour Benhangi
Position
Student of Medicine
Other areas of specialty/work
Street address
Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
zeinab.abbaspour@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Maliheh Zanguei
Position
Assistant Professor in Anesthesia
Other areas of specialty/work
Street address
Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5000
Fax
Email
Zeinab.Abbaspour@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medicl Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
mbroozgar@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)