Efficacy and safety of modified-release paracetamol for acute and chronic pain: a systematic review protocol
| Autor: | Zeljana Margan Koletic, Svjetlana Dosenovic, Livia Puljak |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male safety medicine.medical_specialty Fever paracetamol efficacy MEDLINE Pain relief Administration Oral Pain Drug Administration Schedule Anaesthesia 03 medical and health sciences 0302 clinical medicine medicine Protocol media_common.cataloged_instance Humans suspension modified-release 030212 general & internal medicine European union Adverse effect Intensive care medicine Child media_common Pain Measurement acetaminophen Protocol (science) Dose-Response Relationship Drug business.industry Chronic pain Australia General Medicine Middle Aged medicine.disease Acetaminophen Clinical trial Child Preschool Acute Disease Female Chronic Pain business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | IntroductionParacetamol (acetaminophen) is widely used for management of mild-to-moderate pain and reduction of fever. It is available as immediate release (IR) and modified-release (MR) formulation. In 2017, European Medicines Agency recommended a suspension of marketing of MR paracetamol in the European Union. Benefit-risk balance of these products has been assessed as negative as data showed that existing procedures for overdose management may not be efficient. Since MR paracetamol is still available in other countries (Australia and USA) and there is no available systematic review (SR) of efficacy and safety of MR paracetamol in the literature, we have decided to perform one to evaluate available data from randomised clinical trials (RCTs).Methods and analysisUsing predefined search criteria, we will search EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform to identify RCTs evaluating efficacy and safety of MR paracetamol alone in any dose or duration for any pain. Participants are defined as adults and adolescents (over 12 years). Primary efficacy outcomes will be pain intensity, pain relief and sleep. Primary safety outcomes will be the number of patients experiencing any (serious) adverse event, the number of patients withdrawn due to adverse events and the number of patients with gastrointestinal and hepatic adverse events. Data analysis will be subdivided based on different clinical syndromes. Meta-analysis will be conducted if possible. Cochrane risk of bias (RoB) tool with seven dimensions will be used to assess RoB of individual studies.Ethics and disseminationThis SR will include only data collected from trial reports; therefore, an ethical approval will not be sought. We will publish the protocol and our findings in peer-reviewed journals.PROSPERO registration numberNCT42018115769. |
| Databáze: | OpenAIRE |
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