Fixed time interval compared with on-demand oral analgesia protocols for post-caesarean pain: a randomised controlled trial.

Abstract

To compare the efficacy, safety and satisfaction from two modes of oral analgesia administration for the treatment of post-caesarean pain in the first 48h following surgery: on-demand versus fixed time interval administration. Open label parallel-group, randomised-controlled trial from February to December 2013. University-affiliated hospital in Israel. Two-hundred women who underwent caesarean delivery with regional anaesthesia. Patients were randomly assigned to receive predetermined combinations of tramadol, paracetamol and diclofenac either following patient demand or at predetermined 6-h intervals for the first 48h. If the patient requested additional analgesia, Percocet (oxycodone and paracetamol) was given as a rescue treatment. Pain intensity and satisfaction were self-evaluated with visual analogue scale of 0 (no pain/least satisfaction) to 10 (worst pain/highest satisfaction). Breastfeeding, need for supplemental formula, and maternal and neonatal adverse effects were also evaluated. The 'fixed time interval' group, compared with the 'on-demand' group, had lower mean pain score (2.8±0.84 versus 4.1±0.48, respectively; P<0.0001), higher satisfaction rate (9.1±1.2 versus 8.3±1.5, respectively; P<0.0001), more breastfeeds (23.7±6.5 versus 19.2±6.2, respectively; P<0.0001) and less use of supplemental formulas (8.2±5.2 versus 11.9±6.5, respectively; P<0.0001). The number of times that drugs were given was slightly higher in the 'fixed time interval' group without an increase in maternal adverse effects, which were mild. No adverse effects were reported for the neonates. Administration of oral analgesia in fixed time intervals is superior to drug administration following patient demand without increasing maternal or neonatal adverse outcomes. Oral analgesia in fixed time intervals is superior to analgesia following demand.