Optimising pain control after caesarean section - an evaluation if oxycodone can replace morphine and low potency opioids postoperatively.

INTERVENTION: Trade Name: OxyContin 10 mg Pharmaceutical Form: Tablet Trade Name: OxyContin 20 mg Product Name: OxyContin Product Code: 13831 Pharmaceutical Form: Tablet Trade Name: OxyNorm 5 mg Product Name: OxyNorm Product Code: 16454 Pharmaceutical Form: Capsule* Trade Name: OxyNorm 10 mg/ml Pharmaceutical Form: Intravenous infusion CONDITION: Pain management after elective cesarean section. ; MedDRA version: 12.1 Level: LLT Classification code 10036276 Term: Postoperative analgesia PRIMARY OUTCOME: Main Objective: To investigate if oral oxycodone will can substitute for intravenous morphine during the first 24 hours after cesarean section as well as substitute for codeine during the following 4 days. The mean and maximum NRS for pain assessment will be registred for each of the different time periods (0‐6, 6‐12, 12‐24 and 24‐48 hours) as well as cumulatively and for the whole period. Primary end point(s): To evaluate whether oxycodone is as effective and as safe as the protocol used today in our clinic. The next question is whether administration of a more long‐acting opiate with more stable basic serum levels might also reduce the number of episodes with break‐through pain. Possibly the oral administration will be less time consuming for the midwifes than intravenous injections. ; Secondary Objective: The total amount of opiates (opiate equivalents) will be documented and compared between the groups. The patients evaluation of the whole postoperative period on a scale between 0 and 10 where 10 represents a completely satisfactory pain management. Comparison of parameters related to the mothers mobilization. ; Midwifes will be asked to estimate time used for drug administration.; Specific security variables include: ; Apgar score and collection of samples from the umbilical cord for blood gas analysis. ; Evaluation of the potential effects of opiate exposure on the newborn babies by the neurologic and adaptive capacity score (NACS) (Amiel‐Tison, 1982). ; Measurement of oxycodone levels in breast milk and in serum from mother and child. ; Weight development in the newborns.; Registration of any complications in the newborns leading to specific control or treatment, e.g. bilirubin levels above the normal range. INCLUSION CRITERIA: Women undergoing elective cesarean section at the Karolinska University Hospital. Women who intend to breast feed. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range