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.: PACTR202001726685961 Date of Approval: 22/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy and cost of post cesarean pain management using the world health organization versus us the routine care at nyeri county referral Hospital: A randomized controlled trial
Official scientific title Efficacy and cost of post cesarean pain management using the World Heath Organization versus the Nyeri County referral Hospital: A randomized control trial
Brief summary describing the background and objectives of the trial Despite current advances in analgesics , there is still inadequate post operative pain control . Among women who have undergone cesarean section at NYeri County Referral Hospital: 1. To compare the efficacy of WHO recommended-medications versus the current routine care for post cesarean pain management on adequacy of pain control 2. To compare the cost of WHO recommended medications versus the current routine care for post cesarean management 4. To compare the health care perception of burden and attitude towards the WHO recommended versus us the routine care for post cesarean pain management
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Intervention on post cesarean pain management
Anticipated trial start date 03/06/2019
Actual trial start date 03/06/2019
Anticipated date of last follow up 30/10/2019
Actual Last follow-up date 03/11/2019
Anticipated target sample size (number of participants) 387
Actual target sample size (number of participants) 387
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group WHO Day 1- Morphine 10mg 4 hourly diclofenac 75 mg 8 hourly and paracetamol 1g 8 hourly Day 2- tramadol 100mg 8 hourly diclofenac 50mg 8 hourly and paracetamol 1g 8 hourly Day 3- diclofenac 50mg 8 hourly paracetamol 1g 8 hourly For three days Intervention group will receive the WHO recommended medications 193
Control Group Nyeri county referral hospital Day 1- morphine 10mg 8 hourly Day 2&3- diclofenac 50mg 8 hourly and paracetamol 1 g 8 hourly Three days Nyeri county referral hospital routine care medications 194 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Females 18 years of age and older at screening All patients who have undergone a cesarean section Participants able to provide informed consent both verbal and written Post cs patients having concurrent pain causing conditions Allergy hypersensitivity intolerance to medications Vulnerable populations such as prisoners, mentally unstable to provide consent Suspected or known addiction to drugs of abuse or prescribed medications Clinically unstable post cs patients 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 05/04/2019 Nairobi university ethics and research committee
Ethics Committee Address
Street address City Postal code Country
Kenyatta Avenue Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Efficacy of pin post cesarean section using VAS. Pain satisfaction 72 hours post cesarean using Likert scale and cost of medications used Rest , 6 hours , 12 hours , 24 hours and 72 hours post cesarean section
Secondary Outcome Health care worker Perception of burden and attitudes towards post operative pain management questionannire 72 hours post cesarean section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nyeri county referral hospital Nyeri town Nyeri 10100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Mugambi jackline wanjiku Naivasha Street Naivasha 20117 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mugambi jackline Langata road Naivasha 20117 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
Ngoigo maina Nyeri-hospital road Nyeri 11010100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mugambi Jackine wanjikujacky@gmail.com +254723032054 Naivasha
City Postal code Country Position/Affiliation
Naivasha 20117 Kenya Doctor
Role Name Email Phone Street address
Public Enquiries Jackline Mugambi wanjikujacky@gmail.com +254723032054 Naivashs
City Postal code Country Position/Affiliation
Naivasha 20117 Kenya Doctor
Role Name Email Phone Street address
Scientific Enquiries Mugambi Jackline wanjikujacky@gmail.com +254723032054 Naivasha
City Postal code Country Position/Affiliation
Naivasha 20117 Kenya Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article , after deidentification Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who provide a methodologically sound proposal To achieve aims in the approved proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Proposals should be directed to Wanjikujacky@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