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.: PACTR202307474015398 Date of Approval: 10/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intramuscular pentazocine versus Intramuscular acetaminophen for pain relief during labour in federal medical centre, Abuja: A randomized controlled study.
Official scientific title Intramuscular pentazocine versus Intramuscular acetaminophen for pain relief during labour in federal medical centre, Abuja: A randomized controlled study.
Brief summary describing the background and objectives of the trial Background: Labour pain is recognized globally as one of the most painful physiological events experienced by a woman in her lifetime. There is a need for effective management of labour pain as it weakens the woman in the process of giving birth to a child. Epidural analgesia which gives an effective pain relief is expensive and most patients cannot afford it. Aim and Objectives: To compare the effectiveness of intramuscular pentazocine versus intramuscular acetaminophen in the relief of labour pain among women in active phase of labour at Federal Medical Centre, Abuja. Materials and Methods: This study is a randomized, double-blinded clinical study that will be recruiting a total of 202 parturients with singleton fetus in the active phase of labour between 37 - 42 weeks’ gestation and will be divided into two groups: A and B of 101 parturients each. One group will receive intramuscular pentazocine at a dose of 1 mg/kg but not more than 60 mg while the other group will receive intramuscular acetaminophen at a dose of 15 mg/kg but not more than 900 mg at a cervical dilatation of 4-6 cm. Maternal vital signs will be monitored and labour pain will be assessed using the Visual Analogue Scale (VAS). Neonatal conditions will be assessed using the APGAR scoring system and also the need for admission to the NICU (Neonatal Intensive Care Unit). The overall satisfaction of the parturients with the analgesia will be assessed with Likert scale within 24 hours of child delivery. Data Analysis: International business machines’ Statistical product for service solutions (IBM SPSS) version 28.0 will be used for data entry and analysis. Data will be summarized using frequency tables, means, and standard deviations. Categorical data will be presented as frequencies and percentages. Continuous data will be summarized as means and standard deviation and the groups will be compared using student t-tests. The chi-square will be used to compare the differences in categorical variables.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Labour Analgesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/07/2023
Actual trial start date 03/07/2023
Anticipated date of last follow up 03/10/2023
Actual Last follow-up date 03/11/2023
Anticipated target sample size (number of participants) 202
Actual target sample size (number of participants) 202
Recruitment status Active, not recruiting
Publication URL Nigeria Medical Journal- npmcn.edu.ng
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intramuscular Acetaminophen 15mg/kg once once dosing This group will receive intramuscular acetaminophen at a dose of 15 mg/kg but not more than 900 mg at a cervical dilatation of 4-6 cm. 101
Control Group Intramuscular pentazocine 1mg/kg once once dosing This group will receive intramuscular pentazocine at a dose of 1 mg/kg but not more than 60 mg. 101 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant women, 2.Gestational age between 37 and 42 weeks, 3. Singleton fetus, 4. Active phase of labour, 5.Cervical dilation of 4-6 cm, 6.Consented to participate in the study. 1. Non-consenting pregnant women, 2. Allergy to pentazocine and acetaminophen, 3. Intrauterine fetal death, 4. Fetal distress, 5. Antepartum hemorrhage 6. Chronic or recent liver disease, renal disease, 7. Diabetes mellitus, 8. Cardiopulmonary depression, 9. Multiple gestation 10. Patient with previous Caeserean section 11. Patient with induced labour and augmentation 12. IVF conception. Adult: 19 Year-44 Year 19 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 20/03/2023 federal medical centre Abuja health research ethics committee
Ethics Committee Address
Street address City Postal code Country
plot 95 Research and Institutions District Abuja, beside EFCC HQ / NOUN, Abuja Abuja 900001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Significant reduction in the intensity of labour pain after administration of analgesic agents. 60minutes interval of drug administration ie 60minutes, 120minutes, 180minutes, 240minutes
Secondary Outcome a. Maternal satisfaction with the analgesia b. Side effects associated with pain relief. c. Fetal outcome among the two groups of women who had intramuscular pentazocine and intramuscular acetaminophen in labour. Immediately after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
federal medical centre Abuja plot 95 Research and Institutions District Abuja, beside EFCC HQ / NOUN, Abuja Abuja 900001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Nora Ogbu flat 28f kings court estate, Jabi, Abuja. Abuja 900001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Nora Ogbu flat 28f, kings court estate, Jabi, Abuja 900001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Ekweani John federal medical centre Abuja Abuja 900001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nora Ogbu drnoraogbu@gmail.com +2348063332531 flat 28f, kings court estate, jabi
City Postal code Country Position/Affiliation
Abuja 900001 Nigeria senior registrar in npmcn
Role Name Email Phone Street address
Public Enquiries Juliet Ucha diutonwa@gmail.com +23408035397945 federal medical centre Abuja
City Postal code Country Position/Affiliation
Abuja 900001 Nigeria consultant with npmcn
Role Name Email Phone Street address
Scientific Enquiries John Ekweani johananie@gmail.com +2349050002987 federal medical centre Abuja
City Postal code Country Position/Affiliation
Abuja 900001 Nigeria consultant npmcn
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be protected and only made available after getting permission from participant Informed Consent Form,Study Protocol 2 years open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
national postgraduate medical college of Nigeria obstetrics and gynecology journal 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