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.: PACTR202109731371431 Date of Approval: 30/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pentazocine - Diclofenac Suppository versus Pentazocine - Intramuscular Diclofenac for Post Caesarean Section Analgesia in Ahmadu Bello University Teaching Hospital, Zaria
Official scientific title Pentazocine - Diclofenac Suppository versus Pentazocine - Intramuscular Diclofenac for Post Caesarean Section Analgesia. A Randomized Control Trial
Brief summary describing the background and objectives of the trial Pentazocine alone or combined with intramuscular diclofenac are the most frequently used analgesia for post CS analgesia. The diclofenac suppository is not commonly used in our environment especially in our centre at ABUTH, Shika, Zaria. Aim To compare the efficacy and effectiveness of pentazocine-intramuscular diclofenac versus pentazocine-rectal diclofenac for post caesarean section analgesia Materials and methods The study was a randomized controlled trial were a total of 166 women having CS were randomized into two groups by WINPEPI generated random numbers and received either 100 mg diclofenac suppository 12 hourly or 75 mg intramuscular diclofenac 12 hourly both in combination with 0.5mg/kg intramuscular pentazocine 6 hourly for post-CS analgesia for the first 24 hours post-CS. Primary outcome measure was postoperative pain control while secondary outcome was maternal satisfaction, time to ambulation and commencement of oral feeds, and maternal adverse outcomes. All information were recorded in a structured proforma, entered into SPSS 25 and analysed accordingly. Level of significance was set at p-value <0.05. Results A total of 164 participants completed the study. Of these, 81.7% were hausa and 87.8% were muslims. The mean age of participants was 26.7 years and mean gestational age was 38 weeks. The mean pain scores at 6,12,18 and 24 hours were mild to moderate, comparable in both groups and the differences were not statistically significant. However, the pain score using the VAS was lower than the pain score recorded using NPRS scoring system. Though, this was not statistically significant. There were no statistical significant difference in maternal satisfaction in both groups. The incidence of side effects was more in the intramuscular group, though this was not statistically significant. Conclusion Pentazocine-rectal diclofenac is an effective and safe combination for post caesarean section analgesia. Keywords : caesarean, pentazocine, diclofenac
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/04/2020
Actual trial start date 05/10/2020
Anticipated date of last follow up 26/03/2021
Actual Last follow-up date 30/03/2021
Anticipated target sample size (number of participants) 166
Actual target sample size (number of participants) 164
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pentazocine and Rectal Diclofenac 0.5mg/kg im pentazocine 6 hourly 100mg rectal diclofenac 12 hourly 24 hours 0.5mg/kg pentazocine was given intramuscularly every six hours for 24 hours and 100mg diclofenac suppository was given rectally every 12 hours for 24 hours 82
Control Group Intramuscular pentazocine and intramuscular diclofenac 0.5mg/kg pentazocine 6 hourly and 75mg diclofenac intramuscularly 12 hourly 24 hours 0.5mg/kg pentazocine was given intramuscularly every 6 hours and 75mg diclofenac was given intramuscularly every 12 hours 82 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Elective or emergency caesarean section under spinal anaesthesia 2. Are fully conscious 3. Consent to the study 1. Caesarean section under general, epidural, or combined spinal-epidural anaesthesia 2. History of preexisting opioid dependency 3. History of allergy to pentazocine or diclofenac. 4. Primary Postpartum haemorrhage (blood loss greater than 1000 ml) 5. Stillbirth 6. Delirium 7. Sickle cell haemoglobinopathy 8. Peptic ulcer disease patients 9. Women who do not give consent Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 49 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 30/03/2020 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Sokoto Road PMB 06, Shika Zaria Zaria 810222 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain control 6, 12, 18 and 24 hours
Secondary Outcome maternal satisfaction, time to ambulation and commencement of oral feeds, maternal adverse outcomes 26 hours post operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmadu Bello University Teaching Hospital Sokoto Road PMB 06 Shika Zaria Zaria Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Raji Sekinat Asake Ahmadu Bello University Teaching Hospital Zaria 810222 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Raji Sekinat Asake Department of Obstetrics and Gynaecology, ABUTH Shika Zaria 810222 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
PHARM TAWAKALT TAHIR IMAM department of pharmacy, ABU teaching hospital Zaria 810222 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sekinat Asake Raji sekinat.r@gmail.com +2347030254605 Department of Obstetrics and Gynaecology, ABUTH Shika Zaria
City Postal code Country Position/Affiliation
Shika Zaria 810222 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Nana Hauwa Madugu madugu20007@yahoo.com +2348035896570 Department of Obstetrics and Gynaecology ABUTH
City Postal code Country Position/Affiliation
Shika Zaria 810222 Nigeria HOD Consultant
Role Name Email Phone Street address
Scientific Enquiries Adekunle Oguntayo fayokunmi@yahoo.co.uk +2348033109752 Department of Obstetric and Gynaecology ABUTH
City Postal code Country Position/Affiliation
Shika Zaria 810222 Nigeria Professor Consultant
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 identification (text, tables, and figures) Informed Consent Form,Statistical Analysis Plan,Study Protocol Yes Public
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 09/08/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/08/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information