Preemptive Paracetamol for Postoperative Pain

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02425254

Acronym

PPPP

Enrollment

Registered

2015-04-23

Start date

2016-01-31

Completion date

2018-07-31

Last updated

2015-12-03

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

Conditions

Pain, Surgical Wound

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.

Interventions

DRUGIntravenous paracetamol

1000mg intravenous solution for infusion

DRUGIntravenous saline 0.9%

0.9% sodium chloride in order to ensure double-blinding

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Morphine consumption	24 hours postoperatively	Measured from PCA machine

Secondary

Measure	Time frame	Description
Nausea and vomiting	24 hours	Incidence of nausea or vomiting 24 hours postoperatively
Pruritus	24 hours	Incidence of pruritus 24 hours postoperatively
Sedation	24 hours	Incidence of sedation 24 hours postoperatively
Time to first analgesic request	24 hours	In minutes
Allergic reaction	24 hours	Incidence of allergic reaction (defined as diagnosed by clinician 24 hours postoperatively)
Pain score	1 hour	Numeric rating scale (NRS)
Urinary retention	24 hours	Incidence of urinary retention 24 hours postoperatively

Contacts

Primary ContactJohn Williams, PhD

john.williams7@nottingham.ac.uk01332 724641

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026