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.: PACTR202209818432344 Date of Approval: 15/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A RANDOMISED CONTROLLED STUDY OF INTRAMUSCULAR ACETAMINOPHEN- DICLOFENAC VERSUS ACETAMINOPHEN-PENTAZOCINE FOR PAIN RELIEF DURING MANUAL VACUUM ASPIRATION IN UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL
Official scientific title A RANDOMISED CONTROLLED STUDY OF INTRAMUSCULAR ACETAMINOPHEN- DICLOFENAC VERSUS ACETAMINOPHEN-PENTAZOCINE FOR PAIN RELIEF DURING MANUAL VACUUM ASPIRATION IN UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL
Brief summary describing the background and objectives of the trial Background. The management of first trimester miscarriages using manual vacuum aspiration is a cheap, fast and safe surgical method of uterine evacuation. However, pain that result from cervical manipulation, insertion of cannula and suctioning of uterus makes it intolerable for participants. An effective method of managing pain to forestall this and improve patients satisfaction is vital. A study assessing the effectiveness of acetaminophen-diclofenac versus acetaminophen-pentazocine may provide valuable insight to a more efficacious option with better safety outcome. Aim: This study seeks to compare combined acetaminophen-diclofenac versus acetaminophen-pentazocine for pain relief during manual vacuum aspiration in a randomised controlled study in University of Maiduguri Teaching Hospital. Objective: To determine the effectiveness, side effects and patients’ satisfaction of combined acetaminophen-diclofenac versus acetaminophen-pentazocine for pain relief during manual vacuum aspiration. Methodology: This will be a triple-blind randomised controlled study, comparing the effectiveness, patient satisfaction and side effects of combined acetaminophen-diclofenac versus acetaminophen-pentazocine as a multimodal analgesia for pain control during manual vacuum aspiration. A total of 112 consenting patients will be randomised into two groups. Patients in group A (56 patients) will receive combined acetaminophen-diclofenac while patients allocated in group B (56 patients) will receive acetaminophen-pentazocine for pain relief during manual vacuum aspiration. The primary outcome will be to measure the occurrence of mild or no pain during the procedure. Secondary outcome measures will be the need for rescue analgesia, patients’ satisfaction with analgesia given and side effect profile of analgesia used during the procedure. The data will be entered into SPSS version 20.0 (IBM, Armonk, NY, USA 2011) for statistical analysis.
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 19/04/2022
Actual trial start date 25/04/2022
Anticipated date of last follow up 29/07/2022
Actual Last follow-up date 31/08/2022
Anticipated target sample size (number of participants) 112
Actual target sample size (number of participants) 112
Recruitment status Closed to recruitment,follow-up continuing
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 GROUP B ACETAMINOPHENEPENTAZOCIN GROUP All eligible participants will receive intramuscular acetaminophen (DrugfieldR) 600 mg and intramuscular pentazocine (Zolon) 60 mg 20 minutes before the procedure at the upper lateral gluteal region. A stat dose. All eligible participants will receive intramuscular acetaminophen (DrugfieldR) 600 mg and intramuscular pentazocine (Zolon) 60 mg 20 minutes before the procedure at the upper lateral gluteal region. 56 Active-Treatment of Control Group
Experimental Group GROUP A ACETAMINOPHEN DICLOFENAC A stat dose of intramuscular acetaminophen 600 mg and intramuscular diclofena 75 mg 20 minutes before the procedure. A stat dose All eligible participants will receive intramuscular acetaminophen (DrugfieldR) 600 mg and intramuscular diclofenac sodium (Voltaren) 75 mg 20 minutes before the procedure at the upper lateral gluteal region. 56
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Women diagnosed with miscarriage clinically and/or by pelvic ultrasound scan at a gestational age of 12 weeks or less that requires MVA. 2) Patients that are informed, counselled, and consented to participate in the study. 1) Known peptic ulcer disease patients 2) Allergic reaction to pentazocine, diclofenac and acetaminophen. 3) Septic or hypovolemic shock 4) Patients with chronic liver or kidney disease 5) Known coagulation disorder 6) Patient’s refusal Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 55 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 18/02/2022 University of Maiduguri Teaching Hospital Ethics committee
Ethics Committee Address
Street address City Postal code Country
Bama Road, Maiduguri Maiduguri 600235 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be to determine and compare participant pain perception, when either combined intramuscular acetaminophen-diclofenac or acetaminophen-pentazocine is given for pain relief during manual vacuum aspiration. Thirty minutes after the procedure
Secondary Outcome Secondary outcomes will be the need for rescue analgesia (intramuscular tramadol 100 mg), incidence of dizziness, nausea, vomiting, and participant satisfaction with analgesia regimen used. Thirty minutes after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL MAIDUGURIBAMA BORNO STATE NIGERIA. BAMA ROAD MAIDUGURI MAIDUGURI 600235 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator Dr Maduka Chike Joachim salary account C-17 University of Maiduguri teaching Hospital staff Quarters Maiduguri 600235 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MADUKA CHIKE JOACHIM PERSONAL ACCOUNT C BLOCK, UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL QUARTER, MADUGURI MAIDUGURI 600235 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator CHIKE JOACHIM MADUKA akinjoe83@gmail.com 08037830703 C-QUARTER UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL
City Postal code Country Position/Affiliation
MAIDUGURI 600235 Nigeria POSITION
Role Name Email Phone Street address
Public Enquiries ANGELA CHIKAODILI IHEFOBI angelachika18@gmail.com 08104351088 H BLOCK UNIVERSITY OF MAIDUGURI TEAC
City Postal code Country Position/Affiliation
MAIDUGURI 600235 Nigeria POSITION
Role Name Email Phone Street address
Scientific Enquiries HAMZA BELLO hamzabellomadara@gmail.com 08037686432 H BLOCK UNIVERSITY OF MAIDUGURI TEACHING HOSPITAL
City Postal code Country Position/Affiliation
MAIDUGURI 600235 Nigeria POSITION
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available. Also, individual data that underlies the result reported in the article after d-identification will be shared. Informed Consent Form Immediately following publication. open access
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