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.: PACTR202308755450519 Date of Approval: 07/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparing the efficacy of Intravenous Paracetamol to Imtramuscular Pethidine for labour analgesia in ILorin: A randomized controlled study.
Official scientific title Comparing the efficacy of Intravenous Paracetamol to Imtramuscular Pethidine for labour analgesia in ILorin: A randomized controlled study.
Brief summary describing the background and objectives of the trial Background: Although labour is a physiological process, it is accompanied by significant pain which requires treatment; it is often describe by parturient as the worst pain of their lives. Management of labour pain can be via pharmacological or non- pharmacological methods. Epidural analgesia was reported to provide superior analgesia for labour compared to other methods; however, it is not always readily accessible due to the paucity of personnel and high cost. Although parenteral opioids are readily available and effective, the feto-maternal side effects remain a concern thereby necessitating the search for more suitable alternatives. The role of paracetamol as labour analgesia had been examined by few studies to be comparable to that of opioids with fewer feto-maternal side-effects. However, there is need for more study to further validate this role. Objectives: To compare the effectiveness of intravenous paracetamol to intramuscular pethidine for labour analgesia at University of Ilorin Teaching Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Labour pain Relief
Purpose of the trial Treatment: Drugs
Anticipated trial start date 14/08/2023
Actual trial start date
Anticipated date of last follow up 15/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL nasiruibrahim424@gmail.com
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intravenous paracetamol infusion Participants in group A (study group) shall receive an intravenous infusion of 1000mg PCM in 100ml solution over 15 minutes using a standard gravity-dependent intravenous infusion set. And to be repeated after 4hiurs of labour has not progressed upto 7cm cervical dilitation Over 15 minutes Paracetamol, also called acetaminophen or N-acetyl-p-aminophenol (APAP) is a non-opioid analgesic, it is commonly used in the management of moderate to severe pain. 48
Control Group Intramuscular pethidine 50mg IM pethidine over 1-2 minutes to be repeated after 4 hours provided labour has not progressed upto 7 cm cervical dilitation. For maximum of 2 minutes Pethidine (meperidine) is a synthetic phenylpiperidine derivative with structures unrelated to morphine, although with similar pharmacologic effects butless sedation. It was originally developed as an antimuscarinic agen 48 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
INCLUSION CRITERIA Women with term gestation (37 to 42 weeks), with singleton fetus in cephalic presentation Women who present in active phase of labour (cervical dilatation of 4-6cm), either spontaneous or induced Consent to participate in the study. EXCLUSION CRITERIA Women with cervical dilatation of 7cm or more. Multiple gestation. Women with previous uterine surgery (caesarean section, myomectomy). Women with antepartum haemorrhage in index pregnancy. History of hyper-sensitivity to PCM and/or pethidine. Women with diagnosed liver disease and / or sickle cell disease patient. 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 06/06/2023 University of Ilorin Teaching Hospital Ethical Review committee
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road, oke ose, PMB 1459 Ilorin East 240101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maternal labour pain score perception and satisfaction level with pain relief. Measured with VAS and Likert scale respectively From 30 minutes after intervention administered upto an hour after delivery
Secondary Outcome Maternal side effects (Nausea, vomiting, drowsiness, dyspnoea and hypotension) 2. Fetal heart rate abnormalities. 3. Duration of labour (drug –delivery interval) 4. Apgar score less than seven at five minutes and need for NICU admission 5. Need for anti-opioid (Naloxone). From time of intervention administration till 24 hours post delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching Hospital. Old Jebba Road, oke ose. PMB 1459 Ilorin East 240101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self sponsored University of ilorin Teaching Hospital, Obstetrics and Gynecology Department Ilorin East 240101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self funded University of ilorin Teaching Hospital Ilorin East 240101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nasiru IBRAHIM nasiruibrahim424@gmail.com +2347037957122 University of ilorin Teaching Hospital, Obstetrics and Gynecology Department
City Postal code Country Position/Affiliation
Ilorin East 240101 Nigeria Principal investigator
Role Name Email Phone Street address
Public Enquiries Nasiru IBRAHIM nasiruibrahim424@gmail.com +2347037957122 University of ilorin Teaching Hospital, Obstetrics and Gynecology Department
City Postal code Country Position/Affiliation
Ilorin East 240101 Nigeria Principal investigator
Role Name Email Phone Street address
Scientific Enquiries Nasiru IBRAHIM nasiruibrahim424@gmail.com +2347037957122 University of ilorin Teaching Hospital, Obstetrics and Gynecology Department
City Postal code Country Position/Affiliation
Ilorin East 240101 Nigeria Principal investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All participants data collected during the trial, will later be deidentified and shared including the study protocol, statistical analysis plan, informed consent form and analytical code Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The information will be available after 12 months of publication and will end after seven years of publication. The data will be shared with researchers who have ethical approval for the proposed study. It is meant for individual meta analysis and the data requestor signed a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
nasiruibrahim424@gmail.com 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