title: Fixed time interval compared with on-demand oral analgesia protocols for post-caesarean pain: a randomised controlled trial.
abstract: OBJECTIVE
  To compare the efficacy, safety and satisfaction from two modes of oral analgesia administration for the treatment of post-caesarean pain in the first 48 h following surgery: on-demand versus fixed time interval administration.
  
  
  METHODS
  Open label parallel-group, randomised-controlled trial from February to December 2013.
  
  
  METHODS
  University-affiliated hospital in Israel.
  
  
  METHODS
  Two-hundred women who underwent caesarean delivery with regional anaesthesia.
  
  
  METHODS
  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 48 h. If the patient requested additional analgesia, Percocet (oxycodone and paracetamol) was given as a rescue treatment.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Administration of oral analgesia in fixed time intervals is superior to drug administration following patient demand without increasing maternal or neonatal adverse outcomes.
  
  
  CONCLUSIONS
  Oral analgesia in fixed time intervals is superior to analgesia following demand.
authors.affiliation: Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel.
authors.forename: E
authors.initials: E
authors.lastname: Yefet
authors.affiliation: Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel.
authors.forename: H
authors.initials: H
authors.lastname: Taha
authors.affiliation: Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel.|Rappaport Faculty of Medicine, Technion, Haifa, Israel.
authors.forename: R
authors.initials: R
authors.lastname: Salim
authors.affiliation: Neonatology Department, Emek Medical Center, Afula, Israel.
authors.forename: J
authors.initials: J
authors.lastname: Hasanein
authors.affiliation: Obstetrical Anesthesiology Unit, Department of Anesthesiology, Emek Medical Center, Afula, Israel.
authors.forename: Y
authors.initials: Y
authors.lastname: Carmeli
authors.affiliation: Research Authority, Emek Medical Center, Afula, Israel.
authors.forename: N
authors.initials: N
authors.lastname: Schwartz
authors.affiliation: Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel.|Rappaport Faculty of Medicine, Technion, Haifa, Israel.
authors.forename: Z
authors.initials: Z
authors.lastname: Nachum
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000009:adverse effects; D000284:Administration, Oral; D000328:Adult; D016362:Analgesia, Obstetrical / Q000009:adverse effects / Q000379:methods*; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D002585:Cesarean Section / Q000009:adverse effects*; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007557:Israel; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects; D059408:Pain Management / Q000379:methods; D010147:Pain Measurement / Q000379:methods; D010149:Postoperative Pain / Q000188:drug therapy*; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011247:Pregnancy; D014147:Tramadol / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D004338:Drug Combinations; C514822:oxycodone-acetaminophen; D004008:Diclofenac; D000082:Acetaminophen; D014147:Tramadol; D010098:Oxycodone
keywords: Breastfeeding; caesarean sections; oral analgesia; post-caesarean pain