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.: PACTR202212482289582 Date of Registration: 19/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title RANDOMISED CONTROLLED TRIAL OF INTRAMUSCULAR PENTAZOCINE VERSUS INTRAMUSCULAR DICLOFENAC FOR PAIN RELIEF DURING MANUAL VACUUM ASPIRATION AT FEDERAL TEACHING HOSPITAL KATSINA.
Official scientific title RANDOMISED CONTROLLED TRIAL OF INTRAMUSCULAR PENTAZOCINE VERSUS INTRAMUSCULAR DICLOFENAC FOR PAIN RELIEF DURING MANUAL VACUUM ASPIRATION AT FEDERAL TEACHING HOSPITAL KATSINA.
Brief summary describing the background and objectives of the trial ONE OF THE PROBLEMS OF MVA IS PAIN AND THERE ARE DIFFERENT MODALITIES OF MANAGING PAIN DURING MVA .PENTAZOCINE IS A COMMONLY USED DRUG AT FTH, KATSINA AND ITS ASSOCIATED WITH LOTS OF UNBEARABLE SIDE EFFECTS, HENCE THE NEED FOR AN ALTERNATIVE WITH EQUAL EFFICACY AND LESS SIDE EFFECTS. OBJECTIVES TO COMPARE THE EFFECTIVENESS OF INTRAMUSCULAR PENTAZOCINE WITH INTRAMUSCULAR DICLOFENAC AS PAIN RELIEVING DRUGS DURING MVA. TO COMPARE PAIN PERCEPTION BETWEEN THE PATIENTS WHO HAD PENTAZOCINE AND THOSE WHO HAD DICLOFENAC INJECTION FOR PAIN RELIEF DURING MVA TO COMPARE THE PATIENT SATISFACTION BETWEEN THOSE WHO HAD PENTAZOCINE AND THOSE WHO HAD DICLOFENAC INJECTION FOR PAIN RELIEF DURING MVA. TO COMPARE THE SIDE EFFECTS OF PENTAZOCINE AND DICLOFENAC FOR PAIN RELIEF DURING MVA. TO MAKE A RECOMMENDATION BASED ON THE ABOVE AT FTH, KATSINA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MVA. FTH
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied PAIN RELIEF DURING MANUAL VACUUM ASPIRATION
Purpose of the trial Supportive care
Anticipated trial start date 10/08/2020
Actual trial start date 10/08/2020
Anticipated date of last follow up 17/03/2021
Actual Last follow-up date 05/05/2022
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group INTRAMUSCULAR PENTAZOCINE 30MG STAT 30MG OF INTRAMUSCULAR PENTAZOCINE WAS GIVEN TO A GROUP BEFORE THE PROCEDURE WHILE 75MG OF DICLOFENAC WAS GIVEN TO ANOTHER GROUP BEFORE THE PROCEDURE 50 Active-Treatment of Control Group
Experimental Group INTRAMUSCULAR DICLOFENAC 75MG STAT 75MG OF INTRAMUSCULAR DICLOFENAC WAS GIVEN TO THE EXPERIMENTAL GROUP BEFORE THE PROCEDURE 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ALL CONSENTING WOMEN WHO PRESENTED WITH A MISCARRIAGE OF LESS THAN 12 WEEKS FOR MANUAL VACUUM ASPIRATION MVA FOR ANY OTHER INDICATION APART FROM MISCARRIAGE. OBESITY WOMEN IN WHOM DICLOFENAC IS CONTRAINDICATED LIKE THOSE WITH PEPTIC ULCER DISEASE. HISTORY OF HYPERSENSITIVITY TO PENTAZOCINE OR DICLOFENAC. USE OF ANY KIND OF ANALGESIA WITHIN 12 HOURS. UNCONSCIOUS PATIENTS. PATIENTS IN SHOCK REQUIRING RESUSCITATION. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 22 Year(s) 34 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 24/10/2019 FEDERAL MEDICAL CENTRE KATSINA
Ethics Committee Address
Street address City Postal code Country
JIBIA BYPASS. PMB 2121, KATSINA katsina 820281 Nigeria
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 25/10/2020 FEDERAL MEDICAL CENTRE KATSINA
Ethics Committee Address
Street address City Postal code Country
PMB 2121, JIBIA WAY, OBSTETRICS AND GYNAECOLOGY DEPARTMENT KATSINA KATSINA 820281 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PAIN PERCEPTION USING VISUAL ANALOGUE SCORE WITHIN 10 MINUTES OF THE PROCEDURE
Secondary Outcome PATIENT SATISFACTION USING LIKERT SCALE AND SIDE EFFECTS PROFILE WITHIN 10 MINUTES OF THE PROCEDURE
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL TEACHING HOSPITAL KATSINA. PMB 2121,JIBIA WAY, KATSINA, NIGERIA KATSINA Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Abe Abidemi Job Department of Obstetrics and Gynaecology, PMB 2121.FTH, Katsina Katsina 820281 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Abe Abidemi PMB 2121, FTH, KATSINA KATSINA 820281 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
PROF. JAMILU TUKUR DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, FTH, KATSINA, PMB 2121 KATSINA 820281 Nigeria
DR AISHA ABDURRHAMAN PMB 2121, DEPARTMENT OF OBSTETRICS AND GYNACOLOGY, FTH, KATSINA KATSINA 820281 Nigeria
DR NURA ABDULKARIM PMB 2121, FTH, KATSINA KATSINA 820281 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ABIDEMI ABE drbidemi@yahoo.com 2347038130806 pmb 2121, FTH Katsina
City Postal code Country Position/Affiliation
Katsina 820281 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries JAMILU TUKUR jtukur@yahoo.com 2348037042818 PMB 2121, FTH, JIBIA BYPASS,KATSINA
City Postal code Country Position/Affiliation
KATSINA 820281 Nigeria PROVOST. CONSULTANT
Role Name Email Phone Street address
Public Enquiries AISHA ABDURRHAMAN aisha_abdurrahman@yahoo.com 2348033096164 PMB 2121, FTH, JIBIA BYPASS,KATSINA
City Postal code Country Position/Affiliation
KATSINA 820281 Nigeria CONSULTANT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol immediately other information will be sent through email
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 15/12/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 15/12/2022 Result - 15/12/2022 Result - 15/12/2022 Result - 15/12/2022 Result - 15/12/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information