None listed
Conditions
Brief summary
The aim of this trial is to compare the effectiveness of a vapocoolant (rapidly cooling) spray to a chemical ice pack to usual care for reducing the injection pain experienced by labouring women when water injections are used to manage back pain in labour. Participants will be women in labour at term with a single, head down fetus and requesting analgesia for back pain in labour. Labour back pain occurs in approximately one third of all labours and sterile water injections, which is standard care at all participating sites, has been shown in placebo controlled trials conducted by members of our team, to provide significant pain relief. However, the administration pain experienced by women receiving water injections is significant and in known to act as a deterrent to use. We will randomise eligible women who have elected to have water injections for labour back pain and consent to participate to receive either vapocoolant spray, application of cold packs for 10 minutes prior to injections, or a control group of usual care in which neither the vapocoolant spray or cold packs are used. We expect the study to provide data on the best approach to mitigating the pain of water injections
Interventions
Women in labour and receiving four intradermal injections of 0.1 - 0.3 millilitres of sterile water for management of back pain in labour assessed by visual analogue scale equal to or greater than 6 will receive either the application of a vapocoolant spray applied to the injections sites. The vapocoolant spray PainEase® is manufactured by Gebauer. PainEase® spray and contains 1,1,1,3,3-Pentafluoropropane and 1,1,1,2-Tetrafluoroethane which are non-flammable and. unlike ethyl chloride. are not
Women in labour and receiving four intradermal injections of 0.1 - 0.3 millilitres of sterile water for management of back pain in labour assessed by visual analogue scale equal to or greater than 6 will receive either the application of a vapocoolant spray applied to the injections sites. The vapocoolant spray PainEase® is manufactured by Gebauer. PainEase® spray and contains 1,1,1,3,3-Pentafluoropropane and 1,1,1,2-Tetrafluoroethane which are non-flammable and. unlike ethyl chloride. are not absorbed through the skin and therefore safe to use in pregnancy. The cooling effect occurs through the rapid evaporation. The injection points will be sprayed with PainEase® spray at a distance of 8 cms from skin for a period of five to eight seconds immediately prior to administering the injections. The intervention will be delivered by two midwives working concurrently. Participants in the second intervention group will receive the application of a chemical cold pack to the injection area for 10 minutes prior to the administration of the water injections. Compliance with the administering protocol for both interventions will be recorded on the case report form.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
In labour (spontaneous or induced) Are equal to or greater than 16 years of age Have a term singleton pregnancy (between 37 and 42 weeks gestation) Have a fetus in a cephalic (head down) presentation Experience back pain assessed by visual analogue scale VAS as equal to or greater than 6 Are able to provide informed consent
Exclusion criteria
Multiple pregnancy Malpresentation (breech, transverse, shoulder) Have a serious medical condition at onset of labour (e.g. severe hypertension, diabetes requiring insulin infusion Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia.
Outcome results
None listed