Post-caesaraen section morphine requirements: IV vs oral paracetamol

• Research type

  Research Study

• Full title

  Post-caesarean section morphine requirements: a comparison of IV versus oral paracetamol

• IRAS ID

  6021

• Sponsor organisation

  St. Mary's Hospital, Imperial NHS Trust

• Eudract number

  2008-003735-20

• Clinicaltrials.gov Identifier

  not known

• Research summary

  A combination of pain killersare routinely used after elective caesarean section and this is recommended asthese painkillers work in different ways. The painkillers which are routinelyused include paracetamol, diclofenac (a painkiller and anti-inflammatorysimilar to ibuprofen or aspirin) and morphine. Paracetamol is often givenfollowing surgery in the form of suppository and then tablets/capsules duringthe time in hospital. There are many modes of paracetamol administerationincluding suppository, tablet/capsules or intravenously (via a drip which issited routinely during the caesarean section). The ideal method of administeringparacetamol is not clear. The effectiveness of a painkiller depends on itsabsorption into the bloodstream. It has been shown that in some circumstancesthat suppositories are not effective (i.e. do not give good pain relief) as theonset time is delayed and also they may not be absorbed fully into thebloodstream. The pain relief provided by the oral method (tablets) may bedecreased following surgery for various reasons e.g. nausea and vomiting,delayed stomach emptying due to surgery. The intravenous method has been shownto provide effective pain relief in cases following heart and bone surgery,where the oral method is not suitable (e.g. in patients who are nil by mouthfollowing surgery). The advantage of finding the better method of administerationis that patients may require less morphine after surgery. The advantages ofless morphine usage means that some of the side-effects of morphine e.g.nausea, vomiting, sedation, itch can be avoided. By ensurin women have the bestpain relief with minimal side-effects means that they may be able to care fortheir babies easier and better following caesarean section. In women followingcaesarean section, the ideal method of administering paracetamol is not knownand not been investigated. We wish to know whether the best method ofadministeration is the oral route (tablets/capsules) or the intravenous route(through a drip). If we find that the the intravenous route is better then We'll make it routine to use this method; if not, we will continue using theoral paracetamol. The study is a randomised study. Sometimes we don??t knowwhich way of treating patients is best. To find out, we need to comparedifferent treatments. We put people into groups and give each group a differenttreatment. The results are compared to see if one is better. To try to makesure the groups are the same to start with, each patient is put into a group bychance (randomly). This means that women who are having an elective caesareansection will be randomly (ie by chance) placed into two groups at the end ofthe caesarean section. One group will be given intravenous paracetamol and theother will be given oral paracetamol. You will have a 50:50 chance of being ineither group. The anaesthetic and surgery for the caesarean section willproceed before this otherwise as normal routine.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  08/H0712/87

• Date of REC Opinion

  30 Oct 2008

• REC opinion

  Further Information Favourable Opinion