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.: PACTR201607001703323 Date of Registration: 01/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pentazocine versus combined Pentazocine and Diclofenac for Pain Relief in the First 24 Hours after Caesarean Section: A Randomized Controlled Study.
Official scientific title Pentazocine versus combined Pentazocine and Diclofenac for Pain Relief in the First 24 Hours after Caesarean Section: A Randomized Controlled Study.
Brief summary describing the background and objectives of the trial BACKGROUND Pain is one of the important outcomes of caesarean section. Its management still remains a challenge in a low resource setting like ours. The addition of diclofenac to pentazocine provides effective and safe postoperative analgesia. AIM To compare the efficacy of intramuscular pentazocine only and combined intramuscular pentazocine with diclofenac as pain relief within 24 hours after caesarean section. METHODOLOGY This was a double blind randomized control study in which a computer generated random numbers, each sealed in an envelope with the drugs will be used. Each number was coded with a particular drug: either placebo or diclofenac and each participant will choose a number that corresponds with the one in the envelope. All the participants received pentazocine (Penzor manufactured by Elyzium pharmaceutical Limited, India) 30 mg 4 hourly for 24 hours. In addition ,each participant received either 3 milliliters of water for injection 12 hourly for 24 hours or diclofenac (Olfen-75 manufactured by Merkel, Blaubeuren-Weiler Germany) 75 mg 12 hourly for 24 hours. All the drugs were administered by intramuscular route and each patient were treated along the line of packed analgesic as stated. DATA ANALYSIS The information obtained was entered into a predesigned data sheet. The data was analyzed with Statistical package for Social Science (IBM SPSS statistics) version 20.0. Categorical variables were analyzed using chi square test while the continuous variables were analyzed using the student¿s t-test. The level of significance was set at < 0.05.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Post-Caesarean section analgesia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2014
Actual trial start date 01/04/2015
Anticipated date of last follow up 30/06/2015
Actual Last follow-up date 31/12/2015
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants) 140
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pentazocine plus sterile water for injection 30 mg of intramuscular pentazocine plus 3 milliliters of sterile water for injection (placebo) given intramuscularly every 12 hours for 24 hours post-caesarean section 24 hours 30 mg of intramuscular pentazocine plus 3 milliliters of sterile water for injection (placebo) given intramuscularly every 12 hours for 24 hours post-caesarean section 70
Control Group Pentazocine plus diclofenac 30 mg of intramuscular pentazocine given 4 hourly for 24 hours plus 75 mg of intramuscualr diclofenac given 12 hourly for 24 hours post-caesarean section. 24 hours 30 mg of intramuscular pentazocine given 4 hourly for 24 hours plus 75 mg of intramuscualr diclofenac given 12 hourly for 24 hours post-caesarean section. 70 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
consenting low risk parturients who had either elective or emergency caesarean section Had spinal anaesthesia Conscious Had general anaesthesia Had stillbirth History of allergy to pentazocine or diclofenac. History of severe obstetric haemorrhage Delirium Preexisting opioid dependency Sickle cell haemoglobinopathy Peptic ulcer disease Psychiatric illness Illiteracy and Declined consent to participate in the study despite adequate counselling. 18 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 15/10/2014 Research Ethics Committee,Federal Teaching Hospital,Abakliki
Ethics Committee Address
Street address City Postal code Country
Hspital Street, Abakaliki 480001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain control 1st, 2nd , 6th , 12th , 18th and 24th hour after the surgery
Secondary Outcome patient satisfaction and maternal and neonatal adverse outcomes. 1st, 2nd , 6th , 12th , 18th and 24th hour after the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Teaching Hospital, PMB 102, Abakaliki 480001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Fedral Teaching Hospital,Abakilik Hospital Street Abakaliki 480001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fedral Teaching Hospital,Abakiliki Hospital Street Abakaliki 480001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr. John Okafor Egede Department of Obstetrics and Gynaecology,Federal Teaching Hospital, Abakaliki 480001 Nigeria
Dr. Leonard Ogbonna Ajah Department of Obstetrics and Gynaecology, Faculty Oof Medical Sciences, University of Nigeria, Enugu Campus. Enugu 40001 Nigeria
Prof. OUJ Umeora Department of Obstetrics and Gynaecology,Federal Teaching Hospital, Abakaliki 480001 Nigeria
Dr. Robinson C. Onoh Department of Obstetrics and Gynaecology,Federal Teaching Hospital, Abakaliki 480001 Nigeria
Dr. JAohnson A. Obuna Department of Obstetrics and Gynaecology,Federal Teaching Hospital, Abakaliki 480001 Nigeria
Dr. Napoleon Ekem Department of Obstetrics and Gynaecology,Federal Teaching Hospital, Abakaliki 480001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator John Egede egedejohno@yahoo.com +2348037797950 Department of Obstetrics and Gynaecology, Federal Teaching Hospital,
City Postal code Country Position/Affiliation
Abakaliki 480001 Nigeria Post-fellowship Senior Registrar
Role Name Email Phone Street address
Public Enquiries Leonard Ajah leookpanku@yahoo.com +2348033920789 Department of Obstetrics and Gynaecology, Faculty of Medical Sciences,University of Nigeria,Enugu Campus.
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Lecturer/Honorary Consultant
Role Name Email Phone Street address
Scientific Enquiries Leonard Ajah leookpanku@yahoo.com +2348033920789 Department of Obstetrics and Gynaecology, Faculty of Medical Sciences,University of Nigeria,Enugu Campus.
City Postal code Country Position/Affiliation
Enugu 40001 Nigeria Lecturer/Honorary Consultant
REPORTING
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