Jedna doza gabapentina za liječenje boli nakon operacije u odraslih
Abstract
Background
Gabapentin is an antiepileptic drug, also used in the treatment of neuropathic pain, which is the subject of a Cochrane review, currently under revision. Its efficacy in treating established acute postoperative pain has not been demonstrated.
Objectives
To assess the efficacy and safety of single dose oral gabapentin compared with placebo in established acute postoperative pain using methods that permit comparison with other analgesics.
Search methods
We searched Cochrane CENTRAL, MEDLINE, EMBASE, and the Oxford Pain Relief Database. Additional studies were sought from reference lists of retrieved articles and reviews. Clinical trials databases were searched for unpublished studies; clinical trial reports of several unpublished studies have been made public following litigation in the US.
Selection criteria
Single oral dose, randomised, double‐blind, placebo‐controlled trials of gabapentin for relief of established moderate to severe postoperative pain in adults.
Data collection and analysis
Studies were assessed for methodological quality and data extracted by two review authors independently. Numbers of participants with at least 50% of maximum possible total pain relief (TOTPAR) or summed pain intensity difference (SPID) with gabapentin or placebo were calculated and used to derive relative benefit (RB) or risk (RR), and number‐needed‐to‐treat‐to‐benefit (NNT). Numbers of participants using rescue medication, and time to its use, were sought as additional measures of efficacy. Information on adverse events and withdrawals was collected.
Main results
Four unpublished studies met inclusion criteria; in three, participants had pain following dental surgery, and one followed major orthopaedic surgery; 177 participants were treated with a single dose of gabapentin 250 mg, 21 with gabapentin 500 mg, and 172 with placebo. At least 50% pain relief over 6 hours was achieved by 15% with gabapentin 250 mg and 5% with placebo; giving a RB of 2.5 (95% CI 1.2 to 5.0) and an NNT of 11 (6.4 to 35). Significantly fewer participants needed rescue medication within 6 hours with gabapentin 250 mg than with placebo; NNT to prevent use 5.8. About one third of participants reported adverse events with both gabapentin 250 mg and placebo. No serious adverse events occurred with gabapentin.
Authors' conclusions
Gabapentin 250 mg is statistically superior to placebo in the treatment of established acute postoperative pain, but the NNT of 11 for at least 50% pain relief over 6 hours with gabapentin 250 mg is of limited clinical value and inferior to commonly used analgesics. Gabapentin 250 mg is not clinically useful as a stand‐alone analgesic in established acute postoperative pain, though this is probably the first demonstration of analgesic effect of an antiepileptic in established acute pain.
PICO
Plain language summary
Jedna doza gabapentina za liječenje boli nakon operacije u odraslih
Gabapentin je lijek koji se prvenstveno koristi za liječenje epilepsije, a isto tako i boli koja nastaje zbog oštećenja živaca (neuropatska bol). Gabapentin se obično ne koristi za liječenje boli koja nastaje zbog ozljede ili boli koja nastaje nakon operacije; sporno je može li gabapentin uopće može biti djelotvoran u tim stanjima. Cilj ovog Cochrane sustavnog pregleda bio je ispitati da li je gabapentin djelotvorna terapija za liječenje akutne postoperativne boli u odraslih. Pronađena su 4 neobjavljena klinička pokusa s ukupno 370 ispitanika koji su primali ili gabapentin ili placebo (tabletu bez aktivnog sastojka). Gabapentin je u dozi od 250 mg u određenoj mjeri ublažio bol, ali nije bio djelotvoran kao neki drugi lijekovi koji se za takvu bol već dugo vremena koriste ‐ kao npr. ibuprofen, diklofenak i naproksen, a vjerojatno i paracetamol, sami ili u kombinaciji sa slabim opioidom.
Međutim, sa znanstvenog gledišta, zanimljivo je da lijek koji je izvorno razvijen za liječenje epilepsije ima bilo kakav učinak na liječenje boli koja se javlja nakon kirurškog zahvata. Istraživačka pitanja na koja još uvijek treba odgovoriti jest koja je doza lijeka najbolja i može li kombiniranje gabapentina zajedno s uobičajenim lijekovima protiv bolova omogućiti bolje ublažavanje postoperativne boli nego sami standardni lijekovi.
