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.: PACTR202208650496401 Date of Approval: 02/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Acetaminophen-diclofenac versus acetaminophen-pentazocine combinations for pain relief after caesarean delivery at university of Maiduguri teaching hospital. 'A randomised controlled study'.
Official scientific title Acetaminophen-diclofenac versus acetaminophen-pentazocine combinations for pain relief after caesarean delivery at university of Maiduguri teaching hospital. 'A randomised controlled study'.
Brief summary describing the background and objectives of the trial The rapid rise in caesarean section rate is one of the most disturbing characteristics of modern obstetric practice. Postoperative pain following caesarean section is one of the major predictable and undesirable outcomes of the procedure. Adequate postoperative analgesia following caesarean section is difficult to achieve despite the various modalities that have been in use. The objective of this study is to compare the efficacy of combined acetaminophen-diclofenac versus acetaminophen-pentazocine for pain relief in the first twenty four hours following caesarean section at university of Maiduguri teaching hospital, Maiduguri.
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 Pain management following caesarean delivery
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/06/2022
Actual trial start date
Anticipated date of last follow up 20/08/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Acetaminophen and diclofenac injections Intravenous acetaminophen 900mg every six hours Intramuscular diclofenac 50mg every eight hours Twenty four hours Participants in the experimental arm will receive intravenous acetaminophen 900mg six hourly for twenty hours, and intramuscular diclofenac 50mg eight hourly for twenty hours. 42
Control Group Acetaminophen and pentazocine injections Intravenous acetaminophen 900mg six hourly. Intramuscular pentazocine 60mg eight hourly. Twenty hours The participants in the control group will receive intravenous acetaminophen 900mg six hourly for twenty four hours and intramuscular pentazocine 60mg eight hourly for twenty fours. 42 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Booked Patients. Participants who gave informed consent. Peptic ulcer disease. Chronic kidney disease. Liver disease. Unbooked patients. Allergic reaction to pentazocine, diclofenac and acetaminophen. Sickle cell disease. Participants who will have general anaesthesia. Intrauterine fetal death. Adult: 19 Year-44 Year 15 Year(s) 49 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 15/09/2021 Research and Ethics Committee University of Maiduguri Teaching Hospital Nigeria
Ethics Committee Address
Street address City Postal code Country
Muhammed Bukar Street, Bama Road, Maiduguri, Nigeria Maiduguri 600211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Is to measure the occurrence of severe pains 24 hours postoperatively 24 hours postoperative
Secondary Outcome Is to measure the incidence of nausea and vomiting, time from surgery to initiation of breastfeeding and time from surgery to start of ambulation. 6 hours, 12 hours and 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Maiduguri Teaching Hospital Department of Obstetrics and Gynecology University of Maiduguri Teaching Hospital Maiduguri 600221 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Hilary Ikechukwu Obetta Department of obstetrics and gynaecology, university of Maiduguri teaching hospital. Maiduguri 600221 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hilary Ikechukwu Obetta Number 10 Muhammed Bukar street Maiduguri 600221 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hilary Obetta obettahilary@gmail.com +2347037058969 Number 10 Bukar Muhammed
City Postal code Country Position/Affiliation
Maiduguri 600221 Nigeria Researcher
Role Name Email Phone Street address
Public Enquiries Innocent Dishon innocentdishon@gmail.com +2348034591107 GRA behind wetland
City Postal code Country Position/Affiliation
Nguru 630261 Nigeria General duties
Role Name Email Phone Street address
Scientific Enquiries Hadiza Usman adiusman@yahoo.co.uk +2348038780591 Fore street
City Postal code Country Position/Affiliation
Maiduguri 600221 Nigeria Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Booked pregnant women at University of Maiduguri Teaching Hospital scheduled for either elective or emergency ceaserean section during the period of the study. Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years Open access. for data set request or review of study apply officially to the research and ethics committee University of Maiduguri Teaching Hospital Nigeria.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information