Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402735520583 Date of Approval: 13/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intramuscular Pentazocine Versus Rectal Diclofenac for Pain Relief after Caesarean Section.
Official scientific title Intramuscular Pentazocine versus Rectal Diclofenac for Pain Relief after Caesarean Section: A Randomized Control Trial
Brief summary describing the background and objectives of the trial Background: Caesarean section (CS) commonly causes moderate to severe pain in the first 48 hours after surgery with associated discomfort, delayed ambulation, difficulty initiating breastfeeding and prolonged hospital stay. Adequate analgesia after caesarean section is thus very important for the patient’s comfort, overall wellbeing and recovery. Objective: To compare the analgesic effectiveness of rectal diclofenac with intramuscular Pentazocine in the reduction of pain following caesarean section in Federal Medical Centre, Keffi.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied caeserean section
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/03/2023
Actual trial start date 15/03/2023
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date 20/10/2023
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 240
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group rectal diclofenac 100mg 12hourly for 48hours 48 hours 100mg rectal diclofenac given 12hourly for 48hours after caeserean section 120
Control Group intramuscular pentazocine 60mg 8hourly for 48 hours 48 hours after caeserean section IM Pentazocine 60mg 8hourly x 48hours 120 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who had caesarean delivery under spinal anesthesia that consented. 1. Patients who had caesarean delivery under general anesthesia, epidural combined spinal 2. Patients with medical condition known to be potentially exacerbated by non-steroidal anti-inflammatory drugs such as peptic ulcer disease, renal .disease, Asthma liver disease 3. History of allergy to either of the study medications. 4. Patients with bleeding disorder. 5. Any patient who required special post-operative pain control such as sickle cell disease patient. 6. Patients who did not consent to the study. Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/11/2022 Federal Medical Centre Health Reseach Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Federal Medical Centre Keffi, Nasarawa State keffi 961101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) To compare the effectiveness of intramuscular Pentazocine with rectal diclofenac sodium in post caesarean section pain relief. 6hours, 12hours, 18 hours and 24 hours
Secondary Outcome 2) To compare maternal satisfaction with rectal diclofenac sodium and with intramuscular Pentazocine. 24 hours
Secondary Outcome To determine the side effects/adverse effects experienced by patients in the two groups 6hours, 12 hours, 18 hours and 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Keffi. Keffi, Nasarawa State keffi 961101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
DR. ATONGO TERNGU JESSE Department of Obstetrics and Gynaecology Keffi 961101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR. ATONGO TERNGU JESSE Department of Obstetrics and Gynecology, Federal Medical Centre keffi keffi 961101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator JESSE TERNGU ATONGO jesseatongo@yahoo.com +2347037148734 Department of Obstetrics and Gynecology
City Postal code Country Position/Affiliation
Keffi 961101 Nigeria member West African college of surgeons
Role Name Email Phone Street address
Scientific Enquiries PAULINUS UGWU specialcarehospital@yahoo.com +2347066705396 Department of Obstetrics and Gynecology
City Postal code Country Position/Affiliation
Keffi 961101 Nigeria research assistant
Role Name Email Phone Street address
Public Enquiries winifred Atongo ahungwawinifred@gmail.com +2348105270558 47, abacha road, Mararaba, Nasarawa state
City Postal code Country Position/Affiliation
mararaba 961105 Nigeria Analyst
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The results from study were presented to the department of Obstetrics and Gynaecology, FMC Keffi and have been submitted to the Health Research Ethics Committee of FMC Keffi. A dissertation has been made out from the findings of this study and submitted to the West African College of Surgeons, Faculty of Obstetrics and Gynaecology in part fulfillment of the award of fellowship of the college. Study Protocol 12months open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 01/02/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 01/02/2024 Result - 08/02/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information