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.: PACTR202203615684194 Date of Registration: 15/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intramuscular Paracetamol Versus Intramuscular Tramadol as an Intrapartum Labour Analgesia: A Randomised Controlled Trial
Official scientific title Intramuscular Paracetamol Versus Intramuscular Tramadol as an Intrapartum Labour Analgesia: A Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Labour pain is a complex phenomenon that affects maternal psychology and may affect the course of the labour event. The gold standard of pain relief in labour is the neuraxial analgesia but this method is expensive and requires well trained manpower which is a scarce commodity in the developing nations. As such, an analgesia which is cheap, safe to both the mother and fetus, easily administered, readily available and accessible is required. Opioids which are commonly used in these settings are associated with both maternal and fetal side effects which may be catastrophic if used by labour ward staffs in the rural areas and who may not be well trained to recognize these side effects or reverse the actions of these drugs. Intramuscular paracetamol given during labour has been shown to be effective with fewer side effects. The study is aimed at determining the efficacy of intramuscular paracetamol versus tramadol in pain management during normal labour at the Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Ebonyi State.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) none
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/05/2019
Actual trial start date 01/05/2019
Anticipated date of last follow up 01/10/2019
Actual Last follow-up date 01/10/2019
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants) 140
Recruitment status Completed
Publication URL none
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intramuscular paracetamol group 600mg intramuscular paracetamol and a repeat dose after 4hours from the previous dose when needed. During the labour process (less than or equal to 12 hours) Patients in intramuscular paracetamol group would receive 600mg of paracetamol on the gluteal muscle. Rescue or repeat analgesia would be given when patients demanded, however, this is another analgesia other than the one from the initial pool {e.g. if patient X who was on analgesia A, requires rescue analgesia, she would be given a rescue analgesia from the pool containing analgesia B}. The amount of this rescue analgesia given will help us to know how well the initial analgesia worked and interpretation of the final results of this study. However, if parturients did not demand for analgesia, repeat analgesia from the initial pool, is only given after 4 hours from the initial dose for patients who were still in labour and who were adjudged to need further doses. Labour pain would be assessed at intervals following the initial administration of analgesia (15minutes, 1, 2, 3 and 4hours after). 70
Control Group intramuscular tramadol group 100mg intramuscular tramadol and a repeat 4 hours after the first dose if needed by the paturient duration of labour (less than or equal to 12 hours) Patients in intramuscular tramadol group would receive 100mg of tramadol on the gluteal muscle. Rescue or repeat analgesia would be given when patients demanded, however, this is another analgesia other than the one from the initial pool {e.g. if patient X who was on analgesia A, requires rescue analgesia, she would be given a rescue analgesia from the pool containing analgesia B}. The amount of this rescue analgesia given will help us to know how well the initial analgesia worked and interpretation of the final results of this study. However, if parturients did not demand for analgesia, repeat analgesia from the initial pool, is only given after 4 hours from the initial dose for patients who were still in labour and who were adjudged to need further doses. Labour pain would be assessed at intervals following the initial administration of analgesia (15minutes, 1, 2, 3 and 4hours after). 70 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) booked pregnant women 2) spontaneous onset of labour 3) term singleton fetus, in cephalic presentation 4) no contraindication to vaginal delivery 5) consent to participate in the study. 1. Refusal to give consent 2. Patients with multiple gestation 3. Patients who presented at a gestational age below 37 weeks 4. Patients with history narcotics dependency 5. Patients with cardiopulmonary depression 6. Fetal distress 7. Intrauterine fetal death 8. Antepartum haemorrhage 9. History of recent chronic liver disease 10. Vaginal birth after Caeserean section 11. Breech presenting fetuses 12. History of renal disease 13. Known allergy to acetaminophen/tramadol 14. Any contraindication to vaginal delivery 15. Induced labour 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 10/04/2019 Research and Ethics commiteee of Alex Ekwueme Federal University Teaching Hospital Abakaliki
Ethics Committee Address
Street address City Postal code Country
No 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The efficacy of paracetamol or tramadol in achieving labour analgesia using the visual analogue scale. During labour and within 24 hours after delivery
Secondary Outcome 1. Total duration of the labour event. 2. Presence of adverse maternal or foetal effect 3. Need for additional analgesia 4. Maternal satisfaction During labour and within 48 hours after after delivery in thePost natal ward
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital Abakaliki 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ikenna Ebere 6 ejiofor street Abakaliki Abakaliki 480 Nigeria
Chidebe Christian Anikwe 6 Ejiofor Street Abakaliki Abakaliki Abakaliki Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ebere Ikenna No 6 Ejiofor Street Abakaliki Abakaliki 480 Nigeria Individual
Secondary Sponsor Chidebe C Anikwe 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Chidebe Christian Anikwe 6 Ejiofor Street Abakaliki Abakaliki 480 Nigeria
Leonard Ajah 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ikenna Ebere ikenna_ebere@yahoo.com +2348033972548 6 Ejiofor Street Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria Senior registrar
Role Name Email Phone Street address
Scientific Enquiries Chidebe Anikwe drchideanikwechristian@gmail.com +2348064165965 No 6 Ejiofor street Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria consultant
Role Name Email Phone Street address
Public Enquiries Ikenna Ebere ikenna_ebere@yahoo.com +2348033972548 No 6 ejiofor street Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria senior registrar
Role Name Email Phone Street address
Public Enquiries Leonard Ajah leookpanku@yahoo.com +2348033920789 6 Ejiofor street Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the result reported in the article after deidentification ( text, tables, figures) Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 9 months to end at 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee
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