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.: PACTR202604757190219 Date of Registration: 24/04/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparison of two pain relief injections (tramadol and pentazocine) for women in labour in Enugu,Nigeria.
Official scientific title A randomised controlled trial comparing intramuscular tramadol versus intramuscular pentazocine for labour analgesia in Enugu,Nigeria.
Brief summary describing the background and objectives of the trial Background: Unmanaged labour pain is a significant global health challenge, particularly in resource-limited settings like Enugu, Nigeria, contributing to adverse maternal physiological and psychological outcomes. , . While neuraxial analgesia such as epidural is considered the gold standard, its widespread availability and utilisation are limited across sub-Saharan Africa due to infrastructural, cost, and personnel constraints. Consequently, systemic opioids, notably intramuscular tramadol and pentazocine, remain crucial, accessible, and affordable pharmacological interventions for labour pain relief . Although some comparative studies on these two agents exist there remains a critical gap in robust, recent, and localised evidence concerning their comparative efficacy, maternal and neonatal safety profiles, and patient satisfaction within the Nigerian obstetric population. Aim: This study aims to compare the efficacy and safety of intramuscular tramadol versus intramuscular pentazocine injections for opioid pain relief during labour among parturients in Enugu, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TRAPEN Trial
Disease(s) or condition(s) being studied Anaesthesia,Neonatal Diseases,Obstetrics and Gynecology,Pregnancy and Childbirth,Respiratory
Sub-Disease(s) or condition(s) being studied Analgesia in labour
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/07/2026
Actual trial start date 28/07/2026
Anticipated date of last follow up 10/11/2026
Actual Last follow-up date 30/11/2026
Anticipated target sample size (number of participants) 330
Actual target sample size (number of participants) 330
Recruitment status Not yet recruiting
Publication URL not yet available
Secondary Ids Issuing authority/Trial register
UNTHHREC2025120521 Health Research Ethics Committee UNTH
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group pentazocine 30mg 4-6 hour post administration Controlled arm(pentazocine): A single intramuscular injection of pentazocine 30mg will be administered during active phase labour . Maternal and fetal outcomes including fetal outcomes, including pain relief ,will be monitored for up to 4-6 hours. 165 Active-Treatment of Control Group
Experimental Group tramadol 100mg of intramuscular Tramadol 4-6 hours post-administration Experimental arm: Participants in the experimental arm will receive a single intramuscular injection of tramadol 100mg during active labour. Maternal and fetal outcomes including pain relief, will be monitored for up to 4-6 hours after administration. 165
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Primigravid or multigravid women in active labour (cervical dilatation 4-8 cm). • Gestational age of 37--42 weeks. • Singleton pregnancy with a cephalic presentation. • Pain score of 5 on a 10-point Visual Analogue Scale requesting pain relief. • Haemodynamically stable. • Age 18-44 years. • Ability to understand and provide informed consent. • Known allergy or contraindication to tramadol or pentazocine. • Known opioid dependence or chronic opioid use. • Pre-existing medical conditions (e.g., severe cardiac, renal, hepatic, or neurological disease, uncontrolled hypertension, pre-eclampsia, eclampsia, or gestational diabetes requiring insulin) that might affect drug metabolism or neonatal outcomes. • Any obstetric complications (e.g., antepartum haemorrhage, placenta praevia, abruptio placentae, severe intrauterine growth restriction, chorioamnionitis). • Evidence of foetal distress requiring immediate intervention. • History of psychiatric illness or known psychotomimetic tendencies. • Contraindication to intramuscular injections. • Women who have received any systemic analgesia or regional analgesia during the current labour. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 44 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 18/12/2025 Health Research Ethics Committee UNTH
Ethics Committee Address
Street address City Postal code Country
Ituku /Ozalla , Enugu Enugu 400001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome . Primary Outcome Measure: • Analgesic Efficacy: Measured by changes in pain intensity using a 10-point VAS at baseline, 15, 30, 60, 90, and 120 minutes post-administration, and hourly thereafter until delivery. Total pain relief and peak pain relief will also be assessed. Baseline, 15,30,60,90 and 120 minutes and hourly until delivery.
Secondary Outcome Secondary Outcome Measures: • Maternal Adverse Effects: Incidence and severity of adverse effects (e.g., nausea, vomiting, dizziness, sedation using a sedation score, pruritus, psychotomimetic effects like dysphoria or hallucinations) recorded hourly for 4 hours post-administration. At 30 minutes, 1,2, and 4 hours post-administration, throughout labour, at delivery, and within the immediate postpartum period up to 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital UNTH Ituku /Ozalla , Enugu Enugu 400001 Nigeria
Enugu State University Of Science and Technology Teaching Hospital Parklane Parkllane Road , GRA, Enugu Enugu 400001 Nigeria
Mother Of Christ Specialist Hospital Ogui Road Enugu 400001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Philip Ikechukwu Ugota the researcher Flat 72, police Housing Estate, 4-corners Ozalla, Enugu. Enugu 402105 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Philip Ikechukwu Ugota Flat 72, Police Housing Estate, 4-corners Ozalla Enugu 402105 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Philip Ugota philipugota01@gmail.com 08034688674 Flat 72, Police Housing Estate 4-corners Ozalla, Enugu
City Postal code Country Position/Affiliation
Enugu 402105 Nigeria Resident Doctor University of Nigeria Teaching Hospital UNTH Ituku Ozalla Enugu Nigeria
Role Name Email Phone Street address
Scientific Enquiries Eric Asimadu eric.asimadu@unn.edu.ng 08037504826 University of Nigeria Teaching Hospital Ituku/Ozall, Enugu.
City Postal code Country Position/Affiliation
ENUGU 400001 Nigeria Consultant Obstetrician and Gynaecologist Department of Obstetrics and gynaecology University of Nigerian Teaching Hospital Ituku Ozalla Enugu Nigeria
Role Name Email Phone Street address
Scientific Enquiries Henry Nnaji nnajihc@gmail.com 08037738502 University of Nigeria Teaching Hospital Ituku/ Ozalla Enugu, Nigeria
City Postal code Country Position/Affiliation
Enugu 400001 Nigeria Consultant Obstetrics and gynaecology Department obstetrics University of Nigeria Teaching Hospital ituku Ozalla Enugu Nigeria.
Role Name Email Phone Street address
Public Enquiries Anthony Nweze nwezeanthony85@gmail.com 07035924830 police housing estate 4-cornersozalla,Enugu
City Postal code Country Position/Affiliation
Enugu 402108 Nigeria Senior Registrar Department of Obstetrics and Gynaecology University of Nigeria teaching Hospital Ituku Ozalla Enugu
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IDP Description De-identified individual participant data (IDP) From this trial comparing intramuscular tramadol versus intramuscular pentazocine for labour analgesia will be made available . The data will include demographic characteristics, labour and delivery details, pain scores, and maternal and neonatal outcomes underlying the results reported in the study. Data will be shared upon reasonable request with qualified researchers who provide a methodologically sound proposal. Access will be subject to approval by the principal investigator and, where applicable, the institutional ethics committee. All shared data will be fully anonymized to protect participant confidentiality. Request for access to data should be directed to the corresponding author at philipugota01@gmail.com Informed Consent Form,Statistical Analysis Plan,Study Protocol Individual participant data will be available beginning from 3 months after publication of the primary results and will remain available for up to 5 years thereafter. Access will be granted qualified researchers upon reasonable request, submission of research proposal and approval by the principal investigator, with a signed data use agreement to ensure confidentiality .
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not yet available at this time 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
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 22/04/2026 correction . Data Collection A structured questionnaire will be used to collect baseline socio-demographic and obstetric data. Pain intensity will be recorded by trained research nurses. Maternal adverse effects and vital signs will be continuously monitored and documented in a standardised case report form. Neonatal outcomes will be obtained from delivery room records and paediatrician assessments. Labour progression will be extracted from partograms and delivery records. Maternal satisfaction and qualitative data on preferences will be collected via direct interviews. IDP Description De-identified individual participant data (IDP) From this trial comparing intramuscular tramadol versus intramuscular pentazocine for labour analgesia will be made available . The data will include demographic characteristics, labour and delivery details, pain scores, and maternal and neonatal outcomes underlying the results reported in the study. Data will be shared upon reasonable request with qualified researchers who provide a methodologically sound proposal. Access will be subject to approval by the principal investigator and, where applicable, the institutional ethics committee. All shared data will be fully anonymized to protect participant confidentiality. Request for access to data should be directed to the corresponding author at philipugota01@gmail.com
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 21/04/2026 PACTR Admin 12 month after completion study and publication of primary result 12 months after completion study and publication of primary result
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 22/04/2026 correction 12 months after completion study and publication of primary result Individual participant data will be available beginning from 3 months after publication of the primary results and will remain available for up to 5 years thereafter.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 22/04/2026 correction Access will be granted qualified researchers upon reasonable request, submission of research proposal and approval by the principal investigator, with a signed data use agreement to ensure confidentiality Access will be granted qualified researchers upon reasonable request, submission of research proposal and approval by the principal investigator, with a signed data use agreement to ensure confidentiality .