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.: PACTR202201521544765 Date of Approval: 21/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Local anaesthesia prior to intramuscular Magnesium Sulphate injection to reduce pain: A randomised crossover pilot study
Official scientific title Novel use of local analgesia prior to intramuscular magnesium sulphate injection to reduce pain: A randomised crossover study
Brief summary describing the background and objectives of the trial Magnesium sulphate (MgSO4) is the drug of choice for the prevention and treatment of eclampsia. Magnesium sulphate is administered parenterally by intravenous (IV) or intramuscular (IM) routes. Intramuscular (IM) MgSO4 is given in a large volume with a highly concentrated salt solution and is exceptionally painful. Repeated maintenance doses of IM injections of MgSO4 can be a painful experience. The study is conducted to evaluate the effect of giving local anaesthesia prior to MgSO4 injection on intramuscular pain and patient’s preference on method of administration. The main objectives of the study are to evaluate the following in pregnant and puerperium women receiving magnesium sulphate for eclampsia or preeclampsia: Objectives 1. Determine if giving local anaesthesia using 1milliliter (mL) of 2% lignocaine five minutes prior to intramuscular injections of 5g (10 mL) 50% magnesium sulphate will reduce pain at the injection site compared to the current standard injection of mixed 2% lignocaine and MgSO4. 2. Assess patient’s preference of the injection methods between the one injection method and the two injection method.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Pain in patient with preeclampsia and eclampsia receiving intramuscular magnesium sulphate.
Purpose of the trial Treatment: Other
Anticipated trial start date 04/04/2022
Actual trial start date 04/05/2022
Anticipated date of last follow up 09/01/2023
Actual Last follow-up date 23/07/2022
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 49
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Two injection method 1mL of 2% Lignocaine, intramuscular, once 5g of 50% magnesium sulphate, intramuscular, once once The 1 mL of 2% lignocaine will be administered on either left or right buttock deep intramuscular and the needle will be left in situ. After 5 minutes 5g of Magnesium Sulphate intramuscular will be administered through the same needle. Lignocaine mixed with MgSO4 will be administered in the other buttock. The patient’s perceived pain will be evaluated immediately after receiving the intramuscular Magnesium Sulphate. Simple descriptive words of no pain; mild pain; moderate pain; severe/unbearable pain and the numeric pain scale will be used to evaluate for pain. Participants who will be assessed during the loading dose will receive both the study intervention (two injection) and control (one injection) at the same time and be able to compare and rate the pain perception of both administration at the same time. If the loading dose has previously been administered, we will use two consecutive maintenance dosages where a sequence of the one injection and two injection administration will be randomised by participant. A series of numbered, sealed opaque envelopes with random allocations will be prepared by a person not directly involved in the study. The random sequence will be generated electronically, in the balanced blocks of variable size. Allocation cards marked “One injection first” or “Two injection first” will be sealed in the envelopes. When participants are enrolled, the name of the participant will be entered into a numbered register before the relevant numbered envelope is opened. The patients will be asked what route of administration they prefer after the pain evaluation and the reason for the preferred route of administration. The participants will be asked to compare pain between the two administration methods and state the more painful administration or if they felt similar pain. Because each participant acts as their own control it gives reliable comparison of the two methods and makes it possible to assess patient’s preference 41
Control Group One Injection 1mL of 2% Lignocaine mixed with 5g of 50% magnesium sulphate in one syringe, given one Once 1 mL of 2% Lignocaine mixed with 5g of 50% Magnesium sulphate will be administered in the buttock, deep intramuscular. The patient’s perceived pain will be evaluated immediately after receiving the intramuscular Magnesium Sulphate. Simple descriptive words of no pain; mild pain; moderate pain; severe/unbearable pain and the numeric pain scale will be used to evaluate for pain. Participants who will be assessed during the loading dose will receive both the study intervention (two injection) and control (one injection) at the same time and be able to compare and rate the pain perception of both administration at the same time. If the loading dose has previously been administered, we will use two consecutive maintenance dosages where a sequence of the one injection and two injection administration will be randomised by participant. A series of numbered, sealed opaque envelopes with random allocations will be prepared by a person not directly involved in the study. The random sequence will be generated electronically, in the balanced blocks of variable size. Allocation cards marked “One injection first” or “Two injection first” will be sealed in the envelopes. When participants are enrolled, the name of the participant will be entered into a numbered register before the relevant numbered envelope is opened. The patients will be asked what route of administration they prefer after the pain evaluation and the reason for the preferred route of administration. The participants will be asked to compare pain between the two administration methods and state the more painful administration or if they felt similar pain. Because each participant acts as their own control it gives reliable comparison of the two methods and makes it possible to assess patient’s preference. 41 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient with preeclampsia or eclampsia receiving magnesium sulphate Client willing and consenting to take part in the study Conscious, able to give consent and give answers to questions about pain and preference Age less than 18 years (consenting age ) critically ill patient (very sick, unstable or unconscious patient, GCS <13 or haemo-dynamically unstable patient) Allergic to magnesium sulphate or lignocaine Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 06/10/2021 University of Botswana Institute Review Board
Ethics Committee Address
Street address City Postal code Country
Corner of Notwane and Maputo road Gaborone PB UB708 Botswana
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 02/11/2021 Ministry of Health and Wellness Health Research and Development Division
Ethics Committee Address
Street address City Postal code Country
Nelson Mandela Drive, Gaborone Gaborone PBag 0038 Botswana
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 10/12/2021 Princess Marina Hospital IRB Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Way Gaborone Box 258 Botswana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Verbal report on perceived pain after the injection using using numeric pain scale of 1-10 where 0 is no pain and 10 is unbearable pain. Immediately after receiving the injection
Secondary Outcome Preferred method of injection in the future, that is either one injection or two injection method After receiving both methods of injection administration, after 4 hours when receiving maintenance doses and approximately after 5 minutes when receiving the loading dose
Secondary Outcome Most painful method of injection After receiving both injection methods that is approximately 5 minutes when receiving loading doses and 4 hours when receiving maintenance doses
Secondary Outcome Reason for the preferred future method of injection administration After receiving both injection methods, approximately after 4 hours when maintenance dose and 10 minutes when receiving loading dose
Secondary Outcome Verbal report on perceived pain after receiving intramuscular injection using simple descriptive words that is no pain, mild pain, severe pain and unbearable pain and also Immediately after receiving intramuscular injection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Princess Marina Hospital Hospital way Gaborone Box 258 Botswana
FUNDING SOURCES
Name of source Street address City Postal code Country
Internal Source Hospital Way Gaborone Box 258 Botswana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Botswana Corner of Notwane and Mobuto Road Gaborone PV UB713 Botswana Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Rebecca Luckett Hospital Way Gaborone P Bag 320 Botswana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Modimowame Jamieson jsmiesonwame@gmail.com +26771613355 Kgale View
City Postal code Country Position/Affiliation
Gaborone Box504600 Botswana Department of Obstetrics and Gynaecology Faculty of Medicine University of Botswana and Department of Obstetrics and Gynaecology Princess Marina Hospital. Gaborone Botswana
Role Name Email Phone Street address
Public Enquiries Rebecca Luckett Rebeccaluckett@gmail.com +26774333773 Hospital Way
City Postal code Country Position/Affiliation
Gaborone P Bag 320 Botswana Department of Obstetrics and gynaecology Faculty of Medicine University of Botswana and Department of Obstetrics and gynaecology Princess Marina Hospital Gaborone Botswana
Role Name Email Phone Street address
Scientific Enquiries Justus Hofmeyr justhof@gmail.com +26775946307 Notwane road
City Postal code Country Position/Affiliation
Gaborone PBagUB713 Botswana Department of Obstetrics and gynaecology Faculty of Medicine University of Botswana and Department of Obstetrics and gynaecology Princess Marina Hospital Gaborone Botswana
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data will be provided upon reasonable request within the context of an approved study protocol. Informed Consent Form,Study Protocol After primary publication for five (5) years. Protocols with ethics approval.
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