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Jedna doza intravenskog proparacetamola ili intravenskog paracetamola za ublažavanje boli nakon operacije

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Abstract

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Background

Paracetamol (acetaminophen) is the most commonly prescribed analgesic for the treatment of acute pain. It may be administered orally or intravenously. The efficacy and safety of intravenous (IV) formulations of paracetamol, IV paracetamol and IV propacetamol, compared with placebo and other analgesics, is unclear.

Objectives

To assess the efficacy and safety of IV formulations of paracetamol for treatment of postoperative pain in both adults and children.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 2), MEDLINE (1950 to May 2010), EMBASE (1980 to 2010, Week 18), LILACS (1992 to May 2010) and reference lists of retrieved articles.

Selection criteria

Randomized, double‐blind, placebo‐ or active‐controlled single dose clinical trials of IV propacetamol or IV paracetamol for acute postoperative pain in adults or children.

Data collection and analysis

Two review authors independently assessed the risk of bias and extracted data. We contacted study authors for additional information. We collected adverse event information from the studies.

Main results

Thirty‐six studies (3896 participants) were included. Thirty‐seven percent of participants receiving IV propacetamol/paracetamol experienced at least 50% pain relief over four hours compared with 16% of those receiving placebo (number needed to treat to benefit (NNT = 4.0; 95% confidence interval 3.5 to 4.8). The proportion of participants in IV propacetamol/paracetamol groups experiencing at least 50% pain relief diminished over six hours, as reflected in a higher NNT of 5.3 (4.2 to 6.7). Participants receiving IV propacetamol/paracetamol required 30% less opioid over four hours than those receiving placebo. However, this did not translate to a reduction in opioid‐induced adverse events.

Meta‐analysis of efficacy comparisons between IV propacetamol/paracetamol and active comparators (opioids or nonsteroidal anti‐inflammatories (NSAIDs)) were either not statistically significant, not clinically significant, or both.

Adverse events occurred at similar rates with IV propacetamol or IV paracetamol and placebo. However, pain on infusion occurred more frequently in those receiving IV propacetamol versus placebo (23% versus 1%).

Meta‐analysis did not demonstrate statistically significant differences between IV propacetamol/paracetamol and active comparators for any adverse event except a reduction in the rate of hypotension versus NSAIDs and a reduction in the rate of gastrointestinal disorders versus opioids.

Authors' conclusions

A single dose of both IV propacetamol and IV paracetamol provides around four hours of effective analgesia for about 37% of patients with acute postoperative pain. Both formulations are associated with few adverse events, although patients receiving IV propacetamol have a higher incidence of pain on infusion than both placebo and IV paracetamol.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Laički sažetak

Jedna doza intravenskog proparacetamola ili paracetamola za ublažavanje boli nakon operacije u odraslih i djece

Bol se često javlja nakon kirurških zahvata, i za njeno ublažavanje koriste se rutinski brojni lijekovi. Ovaj Cochrane sustavni pregled procijenio je podatke iz 36 studija u kojima je sudjelovalo ukupno 3896 ispitanika, a koji su imali umjerenu ili intenzivnu bol nakon različitih kirurških zahvata. Rezultati pokazuju da intravenski oblici lijeka paracetamola (ili proparacetamol ili paracetamol) ublažavanju bol tijekom 4 h kod otprilike 40% ispitanika. Izravna usporedba s drugim lijekovima protiv bolova, kao što su morfin i protu‐upalni lijekovi nije pokazala nikakvu razliku u djelotvornosti, iako je taj rezultat možda posljedica malog broja ispitanika u tim usporedbama (studije nisu imale dovoljnu statističku snagu da bi pokazale razliku). Intravensko davanje proparacetamola i paracetamola izazvalo je mali broj nuspojava. Međutim, ispitanici koji su primali intravenski proparacetamol žalili su se na bol na mjestu gdje su dobivali infuziju češće nego oni koji su primali placebo ili intravenski paracetamol.