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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201607001703323 |
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Date of registration:
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01/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pentazocine versus combined Pentazocine and Diclofenac for Pain Relief in the First 24 Hours after Caesarean Section: A Randomized Controlled Study.
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Scientific title:
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Pentazocine versus combined Pentazocine and Diclofenac for Pain Relief in the First 24 Hours after Caesarean Section: A Randomized Controlled Study. |
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Date of first enrolment:
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01/11/2014 |
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Target sample size:
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126 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1703 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program ,Sealed opaque envelopes
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Phase:
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Not Applicable
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Leonard
Ajah |
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Address:
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Department of Obstetrics and Gynaecology, Faculty of Medical Sciences,University of Nigeria,Enugu Campus.
40001
Enugu
Nigeria |
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Telephone:
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+2348033920789 |
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Email:
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leookpanku@yahoo.com |
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Affiliation:
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Lecturer/Honorary Consultant |
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Name:
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Leonard
Ajah |
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Address:
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Department of Obstetrics and Gynaecology, Faculty of Medical Sciences,University of Nigeria,Enugu Campus.
40001
Enugu
Nigeria |
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Telephone:
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+2348033920789 |
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Email:
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leookpanku@yahoo.com |
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Affiliation:
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Lecturer/Honorary Consultant |
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Key inclusion & exclusion criteria
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Inclusion criteria: consenting low risk parturients who had either elective or emergency caesarean section
Had spinal anaesthesia
Conscious
Exclusion criteria: Had general anaesthesia
Had stillbirth
History of allergy to pentazocine or diclofenac.
History of severe obstetric haemorrhage Delirium
Preexisting opioid dependency
Sickle cell haemoglobinopathy
Peptic ulcer disease
Psychiatric illness
Illiteracy and
Declined consent to participate in the study despite adequate counselling.
Age minimum:
18 Year(s)
Age maximum:
49 Year(s)
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy and Childbirth
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Pregnancy and Childbirth
Post-Caesarean section analgesia
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Post-Caesarean section analgesia
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Intervention(s)
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Pentazocine plus diclofenac
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Pentazocine plus sterile water for injection
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Primary Outcome(s)
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Postoperative pain control
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Secondary Outcome(s)
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patient satisfaction and maternal and neonatal adverse outcomes.
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Source(s) of Monetary Support
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Fedral Teaching Hospital,Abakilik
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Ethics review
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Status: Approved
Approval date: 15/10/2014
Contact:
Research Ethics Committee,Federal Teaching Hospital,Abakliki
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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