Analgesic efficacy of sustained release paracetamol in patients with osteoarthritis of the knee
Abstract
AIMS: Paracetamol is widely recommended as the initial treatment for pain associated with osteoarthritis (OA). A sustained release (SR) paracetamol formulation (Panadol Extend) was compared with standard immediate release (IR) paracetamol (Panadol) in patients with knee pain secondary to OA. The primary parameter for assessment of efficacy was patient-assessed global pain relief as determined on day 8 of the treatment period.
METHODS: A double-blind, double-dummy, randomized study was conducted. Patients (n=403) were treated for 7 days with paracetamol 4 g day(-1) (SR paracetamol, two 665 mg tablets taken three times daily; IR paracetamol, two 500 mg tablets taken four times daily). Patients completed daily pain measurements and assessed global pain relief at the end of the study. Therapeutic noninferiority was defined on the basis of achieving statistical noninferiority for global pain relief.
RESULTS: Analysis of the primary parameter for the intention to treat population showed that the difference in proportion of patients (SR-IR paracetamol) achieving a successful response on day 8 was -0.7%; 90% CI (-8.82%, 7.45%), P=0.890. For the per protocol population the difference in proportion was -3.0%; 90% CI (-11.61%, 5.66%), P=0.571. As the lower bound of the 90% CI for the treatment difference in each case was greater than the prespecified value (-15%), SR paracetamol was considered to be statistically noninferior to IR paracetamol in terms of pain relief. The treatments…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 403 participants or records.
Read the paper
Related studies
- Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial
- Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial
- Comparison of the Post-Caesarean Analgesic Effect of Adding Dexmedetomidine to Paracetamol and Ketorolac: A Randomized Clinical Trial
- A triple-blind randomized clinical trial of different associations between dexamethasone and non-steroids anti-inflammatories for preemptive action in third molar extractions
- An open label randomized clinical trial of Indomethacin for mild and moderate hospitalised Covid-19 patients
- Oral paracetamol and/or ibuprofen for treating pain after soft tissue injuries: Single centre double-blind, randomised controlled clinical trial
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.