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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202006496208237 Date of Registration: 11/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title SATC PAIN TRIAL
Official scientific title Scheduled Around the Clock versus Routine Analgesic Dosing for Post Caesarean Pain Control at Kenyatta National Hospital
Brief summary describing the background and objectives of the trial Post caesarean pain management is still sub-optimal despite the available knowledge, research and advanced therapeutic methods. Current guidelines advocate for multi-modal approach to postoperative pain treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 04/08/2019
Actual trial start date 02/09/2019
Anticipated date of last follow up 30/09/2019
Actual Last follow-up date 31/10/2019
Anticipated target sample size (number of participants) 98
Actual target sample size (number of participants) 98
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group scheduled analgesics Morphine 10 mg 6 hourly for 12 hours post-operative Paracetamol 1000 mg administered intravenously every 6 hours for 24 hours Diclofenac rectally 12 hourly given 3 hours after the first paracetamol dose for 24 hours 72 hours hours Scheduled around the clock group Patients received scheduled morphine 10 mg 6 hourly for 12 hours post-operative. Paracetamol 1000 mg administered intravenously every 6 hours for 24 hours Diclofenac rectally 12 hourly given 3 hours after the first paracetamol dose for 24 hours There was no simultaneous administration of medications to allow for continuous pain control. Pain intensity assessed at 0, 4, 10, 24 and 48 hours by the patients. 49
Control Group Routine care Patients received routine analgesia as per Kenyatta National Hospital protocol a) Paracetamol b) NSAIDS c) IV Opioids (Morphine/Tramadol) d) Plus local wound infiltration Rescue analgesia; Morphine 2mg PRN 72 hours All analgesics administered by clinicians preference 49 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients undergoing elective and emergency cesarean section American Society of Anesthesiologists status (ASA) I and II Patients known to have adverse reactions or allergy to study medications Patients too sick/incapable of providing objective pain assessment e.g. mental retardation, visual and hearing impairment. Patients on pain treatment pre-operative Patients on chronic opioid use Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 15 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 03/09/2019 Kenyatta National Hospital University of Nairrobi Ethics Rreview Committee
Ethics Committee Address
Street address City Postal code Country
BOX 20723 Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain score by Visual analogue scale 72 hours
Secondary Outcome Pain satisfaction with pain management during the admission period 72 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital Hopsital road upperhill, Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Jackline Mulunda Box 66564-00800 Nairobi 00800 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jackline Mulunda Box 66564 Nairobi 00800 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
ALFRED OSOTI BOX 66564 NAIROBI 00800 Kenya
ROSA CHEMWEY BOX 66564 NAIROBI 00800 Kenya
ROSE KOSGEI BOX 66564 NAIROBI 00800 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator JACKLINE MULUNDA namutiluj@gmail.com +254721497284 box 66564
City Postal code Country Position/Affiliation
Nairobi 00800 Kenya Registrar Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Jackline Mulunda namutiluj@gmail.com +25472149784 Box 66564
City Postal code Country Position/Affiliation
Nairobi 00800 Kenya Registrar Obstetrics and Gynaecology
Role Name Email Phone Street address
Scientific Enquiries Jackline Mulunda namutiluj@gmail.com +254721497284 66564
City Postal code Country Position/Affiliation
Nairobi 00800 Kenya Registrar Obstetrics and Gynecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that unerlie the results reported after de_identification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol After publication Researchers who provide a methodological proposal
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