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Clinical Trials/NCT02425254
NCT02425254
Unknown
Phase 4

Preemptive Paracetamol for Postoperative Pain: a Randomised, Double-blind, Two Way Crossover Trial

University of Nottingham0 sites50 target enrollmentJanuary 2016

Overview

Phase
Phase 4
Intervention
Intravenous paracetamol
Conditions
Pain
Sponsor
University of Nottingham
Enrollment
50
Primary Endpoint
Morphine consumption
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to test whether a dose of paracetamol given before surgical incision is more effective at reducing postoperative pain and analgesic consumption in cervical spine surgery versus a dose given at the end of surgery.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
July 2018
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged 18-80 years old
  • Patients listed for non-malignant cervical spinal surgery
  • General anaesthesia
  • Capacity to give informed consent
  • Ability to use PCA device and pain score scale
  • ASA I, II and III
  • \>50kg in weight

Exclusion Criteria

  • Allergy or sensitivity to paracetamol, proparacetamol or morphine
  • Liver disease
  • Renal disease (creatinine clearance \<30ml/min)
  • Bleeding disorder
  • Chronic alcoholism
  • Chronic malnutrition
  • Dehydration
  • G6PD deficiency
  • Hypernatraemia (Na \>150)
  • Hypokalaemia (K \<3.5) and hyperchloraemia

Arms & Interventions

Preemptive paracetamol

1000mg intravenous paracetamol given ≥15 minutes before surgical incision and intravenous saline 15 minutes before the end of surgery

Intervention: Intravenous paracetamol

Preemptive paracetamol

1000mg intravenous paracetamol given ≥15 minutes before surgical incision and intravenous saline 15 minutes before the end of surgery

Intervention: Intravenous saline 0.9%

Postincision paracetamol

Intravenous saline ≥15 minutes before surgical incision and 1000mg intravenous paracetamol given 15 minutes before the end of surgery

Intervention: Intravenous paracetamol

Postincision paracetamol

Intravenous saline ≥15 minutes before surgical incision and 1000mg intravenous paracetamol given 15 minutes before the end of surgery

Intervention: Intravenous saline 0.9%

Outcomes

Primary Outcomes

Morphine consumption

Time Frame: 24 hours postoperatively

Measured from PCA machine

Secondary Outcomes

  • Time to first analgesic request(24 hours)
  • Nausea and vomiting(24 hours)
  • Pruritus(24 hours)
  • Sedation(24 hours)
  • Urinary retention(24 hours)
  • Allergic reaction(24 hours)
  • Pain score(24 hours)

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