Preemptive Paracetamol for Postoperative Pain: a Randomised, Double-blind, Two Way Crossover Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- University of Nottingham
- Enrollment
- 50
- Primary Endpoint
- Morphine consumption
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Pregnancy or breast-feeding
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 (Drug)
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% (Drug)
Postincision paracetamol
Intravenous saline ≥15 minutes before surgical incision and 1000mg intravenous paracetamol given 15 minutes before the end of surgery
Intervention: Intravenous paracetamol (Drug)
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% (Drug)
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)