ABSTRACT
OBJECTIVE: To identify the most effective non-pharmacological measures for pain control in preterm infants in the Neonatal Intensive Care Unit (NICU). METHODS: A Systematic review and network meta-analysis of randomized clinical trials published in English, Portuguese, and Spanish from April 2020 to December 2023. The data sources used were MedLine via PubMed, LILACS, EMBASE, The Cochrane Central Register of Controlled Trials, and Pedro. We performed the risk of bias analysis with Rob 2 and the certainty of the evidence and strength of the recommendation using the Grading of Recommendations Assessment, Development, and Evaluation system. We assessed heterogeneity using the Higgins and Thompson I2 test, the classification of interventions using the P-score, and inconsistencies using the Direct Evidence Plot. RESULTS: From 210 publications identified, we utilized 12 studies in analysis with 961 preterm infants, and we combined ten studies in network meta-analysis with 716 preterm infants, and 12 combinations of non-pharmacological measures. With moderate confidence, sensory saturation, sugars, non-nutritive sucking, maternal heart sound, lullaby, breast milk odor/taste, magnetic acupuncture, skin-to-skin contact, and facilitated tucking have been shown to reduce pain in preterm infants when compared to no intervention, placebo, proparacaine or standard NICU routine: sensory saturation [SMD 5,25 IC 95%: -8,98; -1,53], sugars [SMD 2,32 IC 95%: -3,86; -0,79], pacifier [SMD 3,74 IC 95%: -7,30; 0,19], and sugars and pacifier SMD [3,88 IC 95% -7,72; -0,04]. CONCLUSION: Non-pharmacological measures are strongly recommended for pain management in preterm infants in the NICU. IMPLICATIONS FOR CLINICAL PRACTICE: The findings of this study have important implications for policy and practice. This is the only systematic review that compared the effectiveness of non-pharmacological measures, thus making it possible to identify which measure presents the best results and could be the first choice in clinical decision making.
ABSTRACT
BACKGROUND: Fibromyalgia is a heterogeneous condition that appears to be associated with physiological and biochemical disturbances of pain modulation, and that consequently affects numerous other facets of life. Tramadol is currently being explored as an option to manage fibromyalgia pain and other symptoms because of its inhibitory activity of reuptake of neurotransmitters, but its safety and efficacy have not yet been established in these patients. OBJECTIVE: To evaluate the effectiveness and safety of tramadol on the management of symptoms of the syndrome. METHODS: We searched CENTRAL, MEDLINE, EMBASE, LILACS, Opengrey, ClinicalTrials.gov and WHO-ICTRP for randomised controlled trials analysing the association between tramadol used for fibromyalgia either single-agent or in combination with other drugs. Two reviewers independently extracted data and assessed risk of bias using the Cochrane risk-of-bias tool for all included studies. Quality of the evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Four RCTs comprising 459 patients were included. Tramadol-either as a single-agent or in combination with an antidepressant or analgesic-had a positive effect on pain. Tramadol combined with analgesic showed improved quality of life over placebo as measured by the Fibromyalgia Impact Questionnaire at 91 days. However, this difference did not hold for tramadol as a single agent against placebo. The evidence in these articles was rated "low" using the GRADE approach. No serious adverse events were reported. No improvement in depression and quality of sleep were observed. CONCLUSIONS: This systematic review found a dearth of clinical trials on tramadol in patients with fibromyalgia. Although the combination of monoamine and opioid mechanism of tramadol has shown positive effects for fibromyalgia, the available evidence is not sufficient to support or refute the use of tramadol in clinical practice for pain or symptom management. Protocol registration number in the PROSPERO database: CRD42017062139.
