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.: PACTR201508001159254 Date of Approval: 03/06/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intramuscular pentazocine versus diclofenac suppository and intramuscular pentazocine for postcaesarean section pain relief-A double blind RCT
Official scientific title Intramuscular pentazocine versus diclofenac suppository and intramuscular pentazocine for postcaesarean section pain relief-A double blind randomized controlled trial
Brief summary describing the background and objectives of the trial Postoperative pain is a common problem following caesarean section. The unimodal approach of using pentazocine as postcaesarean pain relief is no longer popular and acceptable, hence the need for a safe, easily available and effective multimodal approach. Objectives: To compare the efficacy, side effects, and level of satisfaction of intramuscular pentazocine alone with combination of diclofenac suppository and intramuscular pentazocine
Type of trial RCT
Acronym (If the trial has an acronym then please provide) No acronym
Disease(s) or condition(s) being studied Postcaesarean pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/06/2015
Actual trial start date 10/06/2015
Anticipated date of last follow up 17/08/2015
Actual Last follow-up date 17/08/2015
Anticipated target sample size (number of participants) 136
Actual target sample size (number of participants) 120
Recruitment status Not yet recruiting
Publication URL Not applicable yet
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using coin-tossing Sealed opaque envelopes Open-label(Masking Not Used)
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using coin-tossing Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Diclofenac suppository 100 mg diclofenac suppository 12 hourly 24 hours for both placebo diclofenac and pentazocine Group A (experimental) will receive 100mg diclofenac suppository on the operating table immediately after surgery and 12 hours later. The patient will also receive intramuscular pentazocine 30mg immediately and 6 hourly in the first 24 hours after surgery. 60
Control Group Placebo suppository 100 mg 24 hours Group B: receive Placebo suppository immediately after surgery: repeated after 12 and 24 hrs. Also 30mg intramuscular pentazcine immediately and 6hrly in 24 hrs after surgery 60 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA (American Society of Anesthesiologists¿ Classification) 1 and II status Elective and emergency low segment caesarean section Spinal anaesthesia Refusal to participate in the study Epigastic pain Known peptic ulcer Bleeding problem, excessive intraoperative blood loss (>1000mls) Previous history of hypersensitivity reaction to NSAIDS, pentazocine, tramadoL Excessive perioperative blood loss (>1000mls). 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 Ethics and Research Committee (ERC)
Ethics Committee Address
Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex Ile-Ife 22001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the efficacy, side effects, and level of satisfaction of intramuscular pentazocine alone with combination of diclofenac suppository and intramuscular pentazocine. 2hours post operatively 12 hours postoperatively 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex Hospital road, Ile-Ife 22001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Department of Anaesthesia, Obafemi Awolowo University Teaching Hospitals Complex Ile-Ife 22001 Nigeria
Self Hospital road Ile-Ife 22001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr OLATEJU Simeon Olugbade 4, Iloromu Street Ile-Ife 22001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Adenekan Anthony 54, Mokuro road Ile-Ife 22001 Nigeria
Owojuyigbe Afolabi Modomo Area Ile-Ife 22001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Simeon Olateju gbadeteju2005@yahoo.com +2348033885482 Hospital road
City Postal code Country Position/Affiliation
Ile-Ife 22001 Nigeria Lecturer/Consultant/Obafemi Awolowo University
Role Name Email Phone Street address
Public Enquiries Simeon Olateju gbadeteju2005@yahoo.com +2348033885482 Hospital road
City Postal code Country Position/Affiliation
Ile-Ife 22001 Nigeria Lecturer/Consultant/Obafemi Awolowo University
Role Name Email Phone Street address
Scientific Enquiries Simeon Olateju gbadeteju2005@yahoo.com +2348033885482 Hospital road
City Postal code Country Position/Affiliation
Ile-Ife 22001 Nigeria Lecturer/Consultant/Obafemi Awolowo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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