Assessment Of Pain Associated With Intramuscular Injection Of Magnesium Sulphate With Or Without Lignocaine In Women With Severe Preeclampsia And Conscious Eclamptic Women– A Randomized Control Trial

Abstract

Background World wide Magnesium Sulphate (MgSO4) is the drug of choice for the management severe preeclampsia and eclampsia, used parentrally by intravenous (IV) and intramuscular route(IM). Most common side effect of intramuscular Magnesium Sulphate is pain at the site of injection seen in majority of the patients due to large volume(10ml) and multiple injections practiced in Asian countries. WHO 2006 guidelines recommend addition of 1ml 2% Lignocaine to IM injection of MgSO4. This recommendation is consensus based. There is lack of sufficient data on whether addition of Lignocaine reduces pain at the site of injection. Objective To find out whether addition of 1ml of 2% Lignocaine with MgSO4 in IM injection reduces the injection site pain, when used in severe preeclampsia and conscious eclamptic women using visual (faces) analogue scale of 0 to 10. Methodology This Randomized control trial was done at labour room of department of Obstetrics and Gynaecology, teaching hospital attached to KLE university’s, J N medical college, Belagaum. Total sample size of 90 eligible women were randomized into 2 groups by using sequentially numbered opaque sealed envelop technique (SNOSE)- Group A Magnesium Sulphate with 1ml of 2% Lignocaine . Group B Magnesium Sulphate alone. Injection was given deep IM at upper outer quadrant of alternate buttocks. Pain assessment was done by using visual (faces) analogue scale in both the groups with in 5minutes of 1stinjection , at the end of 4 hours of giving 1st injection and at end of 24 hours or 4hours of the last dose which ever is later. Results As per the CONSORT flow diagram, 101women were approached to participate in the study of which 96 women were eligible, of them 90 women consented and were randomized into 2 groups by SNOSE method. 46 women received MgSO4 with 1ml of 2% Lignocaine and 44 women received MgSO4 alone. Of these, 73 women completed planned course of Pritchard’s regimen and 17 were given partial regimen but were included in analysis of the result (6 were assesed after 1st dose of injection and 11 were available for 2nd assessment. The pain scores were evaluated using Visual(faces) analog scale within 5minutes of injection of 1st dose, 4hours after injection of 1st dose and at the end of 24 hours or 4hours of last dose of injection. There was no statistical significance in mean pain scores between 2 groups within 5minutes of 1st injection(P value 0.897), 4hours after 1st injection(P value 0.138) and the end of 24hours or 4 hours of the last dose of injection(P value 0.423). There was no difference between minimum 4,2,0 and maximum 8,4(Group A) and 6(Group B),4 mean pain scores between the groups at different intervals respectively. Conclusion We conclude that the addition of 1ml of 2% Lignocaine in IM injections of 50% MgSO4 is not beneficial in reducing pain.