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Paracetamol for postoperative pain

Preemptive paracetamol for postoperative pain: a randomised, double blind two way crossover trial - Preemptive paracetamol for postoperative pain

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-001562-26-GB
Enrollment
Unknown
Registered
2015-05-27
Start date
2015-06-16
Completion date
Unknown
Last updated
2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain following surgery MedDRA version: 18.0 Level: LLT Classification code 10000683 Term: Acute back pain System Organ Class: 100000004859 MedDRA version: 18.0 Level: LLT Classification code 10000690 Term: Acute cervical pain System Organ Class: 100000004859 MedDRA version: 18.0 Level: LLT Classification code 10066714 Term: Acute pain System Organ Class: 100000004867

Interventions

Trade Name: Paracetamol 10mg/ml solution for infusion Product Name: Paracetamol 10 mg/ml solution for infusion Product Code: PL 03551/0128 Pharmaceutical Form: Solution for injection/infusion

Sponsors

University of Nottingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age 18-80 years old Elective non-malignant cervical spinal surgery Capacity to give informed consent Ability to use PCA device and pain score scale ASA I, II and III General anaesthesia >50kg in weight Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: Allergy or sensitivity to paracetamol, proparacetamol or morphine Liver disease Renal disease (creatinine clearance 150) Hypokalaemia (K <3.5) and hyperchloraemia Pregnancy/breastfeeding

Design outcomes

Primary

MeasureTime frame
Main Objective: To test whether a dose of paracetamol given before surgical incision is more effective at reducing postoperative pain and painkiller consumption versus a dose given at the end of surgery;Secondary Objective: To test whether a dose of paracetamol given before surgical incision is more effective at reducing morphine side effects versus a dose given at the end of surgery;Primary end point(s): Pain scores 1,2,6,12 and 24 hours 24-hour morphine consumption ;Timepoint(s) of evaluation of this end point: 24 hours—

Secondary

MeasureTime frame
Secondary end point(s): Time to first analgesic request Nausea and vomiting Pruritus Sedation Urinary retention Allergic reaction ;Timepoint(s) of evaluation of this end point: 24 hours—

Countries

United Kingdom

Contacts

Public ContactJohn P Williams

University of Nottingham

john.williams7@nottingham.ac.uk01332724621

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026