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.: PACTR202212654526624 Date of Approval: 21/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Diclofenac versus Pentazocine Hydrocloride for analgesia In first stage labour: a Randomised Controlled Trial
Official scientific title Diclofenac versus Pentazocine Hydrocloride for analgesia In first stage labour: a Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Background Labour is a distressing condition associated with severe pain. Therefore, adequate pain management is important in making this process less distressing. Achieving this can be challenging especially in resource-poor environments with low capacity to provide epidural analgesia for every woman leading to the continued search for alternatives. Opioids are effective but are associated with a wide range of maternal and fetal side effects necessitating the continued search for effective, safer alternatives. Aim To compare the effectiveness of intramuscular diclofenac with intramuscular pentazocine as analgesics in the first stage of labour JUSTIFICATION FOR THE STUDY Providing adequate pain control during labour is an important aspect of active management of labour. Of the known analgesics used in labour, epidural analgesia is the gold standard. However, this service is not routinely available to every woman in labour due to its high cost and the lack of manpower with the requisite skill for the procedure especially in resource-poor centres. Non-regional analgesics currently in use in the first stage of labour such as opioids (tramadol and pentazocine) and other non-opioids have been associated with various maternal and neonatal side effects. Diclofenac and other NSAID have good analgesic effects but have not been widely used in providing analgesia in labour. A study comparing diclofenac and a placebo (normal saline) as analgesic in the first stage of labour done by Al-Assadi AF and published in 2015 showed that diclofenac was effective and lacked the side effects associated with pentazocine. This study therefore became necessary as the search for safer, cheaper, easy-to-administer and equally or more effective non-regional analgesic in labour continues.
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: Drugs
Anticipated trial start date 11/12/2019
Actual trial start date 01/01/2020
Anticipated date of last follow up 01/07/2020
Actual Last follow-up date 01/08/2020
Anticipated target sample size (number of participants) 650
Actual target sample size (number of participants) 650
Recruitment status Completed
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group PENTAZOCINE HYDROCLORIDE group They were given a single dose of 30mg (2ml) pentazocine by deep I.M injection in the gluteal area. A dose They were given a single dose of 30mg (2ml) pentazocine by deep I.M injection in the gluteal area. Pain was reassessed at 30minutes, 60minutes and 120minutes by the researcher or same research assistant. Further management of labour was carried out according to standard protocol for labour management. 325 Active-Treatment of Control Group
Experimental Group DICLOFENAC group A dose of IM 75mg Diclofenac A dose They were given a single dose of 75mg (2ml) Diclofenac (Olfen) by deep I.M injection in the gluteal area. Pain was reassessed at 30minutes, 60minutes and 120minutes by the researcher or same research assistant. Further management of labour was carried out according to standard protocol for labour management. 325
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Previously selected booked primigravidae and multiparous women (Para 1–4) with a term pregnancy admitted to the labour room in the active phase of labour with a cervical dilatation from 4–7cm with no contraindication to the use of diclofenac or pentazocine. 2. Women in active phase labour with singleton fetus. 1. Unbooked status. 2. History of medical diseases (diabetes mellitus, hypertension, cardiac deceases, chronic renal disease, peptic ulcer disease, bleeding disorder and bronchial asthma). 3. Grandmultiparity 4. History of previous uterine scar, multiple gestation, preterm labour 5. History of opioid addiction Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 50 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 05/11/2019 Alex Ekwueme Federal University Teaching Hospital Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
No 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria
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 28/09/2020 Mile 4 Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mile 4 Road Abakaliki Abakaliki 480 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Pain score recorded at 30, 60 and 120 minutes following injection of IM diclofenac 75mg. 2. Pain score recorded at 30, 60 and 120 minutes following injection of IM pentazocine 30mg. During labour 30, 60, 120 minutes after injection
Secondary Outcome 1. Maternal side effects of diclofenac noted 2. Fetal side effects of diclofenac noted 4. Maternal side effects of pentazocine noted 5. Fetal side effects of pentazocine noted During labour following administration of drugs, immediate postpartum period to 2-3 days after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Hospital Abakaliki Ebonyi State No 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria
Mile 4 Hospital Abakaliki Ebonyi State Mile 4 Road Abakaliki Abakaliki 480 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Osuafor No 6 Ejiofor street Abakaliki abakaliki 480 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Osuagwu No 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria Individual
Primary Sponsor Dr Anikwe CC No 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Anikwe CC No 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria
Dr Dimejesi No 6 Ejiofor street Abakaliki Abakaliki 480 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator OSUAGWU CHIDUBEM PHILIP philiman2020@gmail.com 08113326246 No 6 Ejiofor Street
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Chidebe C Anikwe drchideanikwechristian@gmail.com 08064165965 No 6 Ejiofor Street
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria consultant
Role Name Email Phone Street address
Public Enquiries Ikechukwu Dimejesi ikedimejesi@gmail.com 08033656433 No 6 Ejiofor Street
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, figure) 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