Infraorbital nerve block for postoperative pain following cleft lip repair in children.

BACKGROUND: Postoperative pain is a barrier to the quality of paediatric care, the proper management of which is a challenge. Acute postoperative pain often leads to adverse functional and organic consequences that may compromise surgical outcome. Cleft lip is one of the most common craniofacial birth defects and requires surgical correction early in life. As expected after a surgical intervention in such a sensitive and delicate area, the immediate postoperative period of cleft lip repair may be associated with moderate to severe pain. Infraorbital nerve block associated with general anaesthesia has been used to reduce postoperative pain after cleft lip repair. OBJECTIVES: To assess the effects of infraorbital nerve block for postoperative pain following cleft lip repair in children. SEARCH METHODS: We searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library, Issue 6, 2015), MEDLINE, EMBASE, and Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) from inception to 17 June 2015. There were no language restrictions. We searched for ongoing trials in the following platforms: the metaRegister of Controlled Trials; ClinicalTrials.gov (the US National Institutes of Health Ongoing Trials Register), and the World Health Organization International Clinical Trials Registry Platform (on 17 June 2015). We checked reference lists of the included studies to identify any additional studies. We contacted specialists in the field and authors of the included trials for unpublished data. SELECTION CRITERIA: We included randomised controlled clinical trials that tested perioperative infraorbital nerve block for cleft lip repair in children, compared with other types of analgesia procedure, no intervention, or placebo (sham nerve block). We considered the type of drug, dosage, and route of administration used in each study. For the purposes of this review, the term 'perioperative' refers to the three phases of surgery, that is preoperative, intraoperative, and postoperative, and commonly includes ward admission, anaesthesia, surgery, and recovery. DATA COLLECTION AND ANALYSIS: Two review authors (GF and EH) independently identified, screened, and selected the studies, assessed trial quality, and performed data extraction using the Cochrane Pain, Palliative and Supportive Care Review Group criteria. In case of disagreements, a third review author (EMKS) was consulted. We assessed the evidence using Grading of Recommendations, Assessment, Development and Evaluation (GRADE). MAIN RESULTS: We included eight studies involving 353 children in the review. These studies reported different types of interventions (lignocaine or bupivacaine), observation times, and forms of measuring and describing the outcomes, making it difficult to conduct meta-analyses. In the comparison of infraorbital nerve block versus placebo, there was a large effect in mean postoperative pain scores (our first primary outcome) favouring the intervention group (standardised mean difference (SMD) -3.54, 95% confidence interval (CI) -6.13 to -0.95; very low-quality evidence; 3 studies; 120 children). Only one study reported the duration of analgesia (in hours) (second primary outcome) with a difference favouring the intervention group (mean difference (MD) 8.26 hours, 95% CI 5.41 to 11.11; very low-quality evidence) and less supplemental analgesic requirements in the intervention group (risk ratio (RR) 0.05, 95% CI 0.01 to 0.18; low-quality evidence). In the comparison of infraorbital nerve block versus intravenous analgesia, there was a difference favouring the intervention group in mean postoperative pain scores (SMD -1.50, 95% CI -2.40 to -0.60; very low-quality evidence; 2 studies; 107 children) and in the time to feeding (MD -9.45 minutes, 95% CI -17.37 to -1.53; moderate-quality evidence; 2 studies; 128 children). No significant adverse events (third primary outcome) were associated with the intervention, although three studies did not report this outcome. Five out of eight studies found no unwanted side effects after the nerve blocks. Overall, the included studies were at low or unclear risk of bias. The reasons for downgrading the quality of the evidence using GRADE related to the lack of information about randomisation methods and allocation concealment in the studies, very small sample sizes, and heterogeneity of outcome reporting. AUTHORS' CONCLUSIONS: There is low- to very low-quality evidence that infraorbital nerve block with lignocaine or bupivacaine may reduce postoperative pain more than placebo and intravenous analgesia in children undergoing cleft lip repair. Further studies with larger samples are needed. Future studies should standardise the observation time and the instruments used to measure outcomes, and stratify children by age group.

Beta-blockers for preventing stroke recurrence.

BACKGROUND: Stroke affects 15 million people per year worldwide. Despite recent developments in acute stroke treatment, prevention remains very important. Stroke has a high rate of recurrence; therefore secondary prevention is also important. Many clinical approaches to control risk factors have been proposed. One of these approaches is the prescription of beta-blockers that have effects beyond the reduction of blood pressure, which can reduce the recurrence of stroke. OBJECTIVES: To evaluate the efficacy of beta-blockers for preventing stroke recurrence and for reducing death and major vascular events in people with a previous stroke or transient ischaemic attack (TIA), and to determine their safety, particularly with regard to the development of diabetes mellitus. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (December 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Database of Systematic Reviews (CDSR) (The Cochrane Library 2011, Issue 12), the Database of Abstracts of Reviews of Effects (DARE) (December 2011), MEDLINE (1966 to December 2011), EMBASE (1980 to December 2011), and Latin American and Caribbean Health Sciences Literature (LILACS) (1982 to December 2011). We also searched ongoing trials registers and reference lists. SELECTION CRITERIA: Randomised controlled trials (RCTs) that included participants with previous stroke or TIA due to arterial thrombosis or embolism.The intervention was any beta-blocker versus control, or beta-blocker plus other treatment versus other treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the trials identified, appraised quality, and extracted data. MAIN RESULTS: We included two RCTs involving 2193 participants in the review. Both studies randomised participants to either beta-blocker (atenolol 5 mg) or placebo. No statistical differences were noted among the groups in risks of fatal and non-fatal stroke (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.75 to 1.17). For all other outcomes analysed (death from all causes, cardiac death, non-fatal myocardial infarction, major vascular events), we observed no significant differences between the groups. AUTHORS' CONCLUSIONS: To date, no available evidence supports the routine use of beta-blockers for secondary prevention after stroke or TIA. More studies with larger samples are needed.

Botulinum toxin for myofascial pain syndromes in adults.

BACKGROUND: Myofascial pain syndrome (MPS) is a regional muscular pain syndrome characterised by the presence of trigger points, which are painful points in one or more muscles. The pain can be felt at the site where the trigger point is located or it can be felt away from that place when the muscle is pressed (referred pain). Botulinum toxin is a protein produced by the bacterium Clostridium botulinum and is a potent neurotoxin that eventually inhibits muscle contractions. It is capable of selectively weakening painful muscles and interrupting the pain cycle. OBJECTIVES: To assess the effectiveness and safety of botulinum toxin in treating MPS, excluding MPS in neck and head muscles. SEARCH METHODS: The search strategy was composed of terms for myofascial pain and botulinum toxin. We searched the Cochrane Pain, Palliative and Supportive Care (PaPaS) Review Group's Specialised Register until December 2011, CENTRAL (Cochrane Database of Systematic Reviews 2011, Issue 4), PUBMED (from 1966 to 2011), EMBASE (from 1980 to 2011) and LILACS (from 1982 to 2011). There was no language restriction. SELECTION CRITERIA: We included randomised controlled trials (RCTs) involving botulinum toxin for treating participants with MPS. We excluded studies with MPS of the neck and head from this review, as they have already been assessed in existing systematic reviews. We considered a diagnosis of MPS to be based on the identification of trigger points in the taut band through palpation of sensitive nodules, local twitch response and specific patterns of referred pain associated with each trigger point. DATA COLLECTION AND ANALYSIS: Two review authors independently screened identified studies, extracted data, assessed trial quality and analysed results using the Cochrane PaPaS Review Group criteria. MAIN RESULTS: Four studies with a total of 233 participants, comparing botulinum toxin A (BTXA) with placebo, met the inclusion criteria. In one study with 145 participants, a significant improvement rate of pain intensity scores, as shown by the mean difference (MD) of -0.23 (95% confidence interval (CI) -0.26 to -0.20; P value < 0.00001) and duration of daily pain (MD -1.11; 95% CI -1.37 to -0.85; P value < 0.00001), was demonstrated when comparing BTXA with placebo. The three other studies showed that there was no statistically significant difference between BTXA and placebo in pain intensity. AUTHORS' CONCLUSIONS: There is inconclusive evidence to support the use of botulinum toxin in the treatment of MPS based on data from four studies with a total of 233 participants, which we considered adequate to be included in this review. Meta-analyses were not possible due to the heterogeneity between studies. We suggest that in future studies the same methodology to assess pain, a standardised dose of treatment, follow-up of at least four months (to observe the maximum/minimum curve of the drug effect) and appropriate data presentation should be used. More high-quality RCTs of botulinum toxin for treating MPS need to be conducted before firm conclusions on its effectiveness and safety can be drawn.

Stapled versus handsewn methods for colorectal anastomosis surgery.

BACKGROUND: Previous systematic reviews comparing stapled and handsewn colorectal anastomosis that are available in the medical literature have not shown either technique to be superior. An update of this systematic review was performed to find out if there are any data that properly answer this question. OBJECTIVES: To compare the safety and effectiveness of stapled and handsewn colorectal anastomosis surgery. The following primary hypothesis was tested: the stapled technique is more effective because it decreases the level of complications. SEARCH METHODS: A computerized search was performed in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE according to the strategies of the Colorectal Cancer Group of The Cochrane Collaboration. There were no limits upon language, date or other criteria. A revised search strategy was performed for this updated version of the review May 2011. SELECTION CRITERIA: All randomised controlled trials (RCTs) in which stapled and handsewn colorectal anastomosis techniques were compared. Participants were adult patients undergoing elective colorectal anastomosis surgery. The interventions were endoluminal circular stapler and handsewn colorectal anastomosis surgery. Outcomes considered were a) mortality; b) overall anastomotic dehiscence; c) clinical anastomotic dehiscence; d) radiological anastomotic dehiscence; e) stricture; f) anastomotic haemorrhage; g) reoperation; h) wound infection; i) anastomosis duration; and j) hospital stay. DATA COLLECTION AND ANALYSIS: Data were independently analysed by the two review authors (CBN, SASL) and cross-checked. The methodological quality of each trial was assessed by the same two authors. After searching the literature for this update, no study was added to those in the previous version of this review. Details of randomizations (generation and concealment), blinding, whether an intention-to-treat analysis was done or not, and the number of patients lost to follow-up were recorded. The analysis of the risk of bias was updated according to the software Review Manager 5.1. The results of each RCT were summarized on an intention-to-treat basis in 2 x 2 tables for each outcome. External validity was defined by the characteristics of the participants, interventions and the outcomes. The RCTs were stratified according to the level of colorectal anastomosis. The risk difference (RD) method (random-effects model) and number needed to treat (NNT) for dichotomous outcome measures and weighted mean differences (WMD) for continuous outcomes measures, with the corresponding 95% confidence intervals (CI), were presented in this review. Statistical heterogeneity was evaluated using a funnel plot and the Chi(2) test. MAIN RESULTS: Of the 1233 patients enrolled in nine identified trials, 622 were treated with staples and 611 with manual suture. The following main results were obtained. a) Mortality, result based on 901 patients: RD -0.6%, 95% CI -2.8% to +1.6%. b) Overall dehiscence, result based on 1233 patients: RD 0.2%, 95% CI -5.0% to +5.3%. c) Clinical anastomotic dehiscence, result based on 1233 patients: RD -1.4%, 95% CI -5.2 to +2.3%. d) Radiological anastomotic dehiscence, result based on 825 patients: RD 1.2%, 95% CI -4.8% to +7.3%. e) Stricture, result based on 1042 patients: RD 4.6%, 95% CI 1.2% to 8.1%; NNT 17, 95% CI 12 to 31. f) Anastomotic haemorrhage, result based on 662 patients: RD 2.7%, 95% CI -0.1% to +5.5%. g) Reoperation, result based on 544 patients: RD 3.9%, 95% CI 0.3% to 7.4%. h) Wound infection, result based on 567 patients: RD 1.0%, 95% CI -2.2% to +4.3%. i) Anastomosis duration, result based on one study (159 patients): WMD -7.6 minutes, 95% CI -12.9 to -2.2 minutes. j) Hospital stay, result based on one study (159 patients): WMD 2.0 days, 95% CI -3.27 to +7.2 days. AUTHORS' CONCLUSIONS: The evidence found was insufficient to demonstrate any superiority of stapled over handsewn techniques in colorectal anastomosis surgery, regardless of the level of anastomosis. There were no randomised clinical trials comparing these two types of anastomosis in elective conditions in the last decade. The relevance of this research question has possibly lost its strength where elective surgery is concerned. However, in risk situations, such as emergency surgery, trauma and inflammatory bowel disease, new clinical trials are needed.