Evidence-Based Medicine

Research Appraisals

Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.

Showing 4 appraisals

Randomised Controlled TrialEvidence: Weak
55CEBM

European journal of pediatrics

Efficacy and safety of procedural sedation-analgesia during laser photocoagulation for retinopathy of prematurity: a systematic review

UNLABELLED: Laser photocoagulation for retinopathy of prematurity (ROP) in preterm infants causes significant procedural pain. Although general anaesthesia (GA) is the standard of care, many settings frequently rely on inadequate sedation-analgesia or topical anaesthesia alone, exposing neonates to considerable pain and clinical instability. This systematic review aimed to evaluate the efficacy and safety of procedural sedation-analgesia during laser photocoagulation for ROP. We searched MEDLINE, Embase, and Cochrane CENTRAL for trials investigating sedation-analgesic agents during laser photocoagulation. Primary outcome was analgesic efficacy (pain score reduction, rescue analgesics required). Additional outcomes included adverse effects (e.g., apnea, oxygen requirement). Two reviewers extracted relevant information and assessed risk-of-bias using ROB2 and evidence certainty using GRADE methodology. Of 540 articles screened, four relevant RCTs were identified (n = 265). These RCTs compared varying combinations of agents (oral dextrose vs. no dextrose, fentanyl vs. oral sucrose, fentanyl vs. ketamine, ketamine-propofol vs. GA). Three RCTs evaluating pain-related outcomes (PIPP-R score and intra-procedural crying duration) suggested that the investigated non-general anaesthetic regimens may provide inadequate procedural analgesia (low to very low-certainty evidence). The evidence is very uncertain about the effect of ketamine-propofol on post-procedure ventilation requirement compared with general anaesthesia. Apnea was the commonest adverse effect (three studies), especially with high-dose fentanyl (30%). Three studies had a low risk-of-bias, while one had some concerns (randomisation, outcome measurement). CONCLUSION: Overall, the included studies were small RCTs evaluating varying combinations of interventions, precluding concrete conclusions about the superiority of any analgesic regimen during laser photocoagulation. Further high-quality studies are needed to identify safe and effective analgesia for settings where GA is unavailable. REVIEW REGISTRATION: Prospectively registered on PROSPERO (CRD420251070146). WHAT IS KNOWN: • Laser photocoagulation procedure for retinopathy of prematurity is immensely painful. • Despite general anaesthesia being the standard, most neonates undergo the procedure under inadequate analgesia, particularly in high-burden settings. Optimal analgesic regimen for the laser procedure, in settings where general anaesthesia is unavailable, is unknown. WHAT IS NEW: • This systematic review of trials investigating analgesic agents for laser procedure for ROP found four RCTs with significant heterogeneity in intervention agents. • Low- to very low-certainty evidence suggests that none of the evaluated sedo-analgesic regimens consistently achieved optimal analgesia, and most infants continued to experience moderate-to-severe procedural pain.

13 July 2026

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Randomised Controlled TrialEvidence: Moderate
60CEBM

The New England journal of medicine

Decompression with or without Duraplasty for Chiari I and Syringomyelia

BACKGROUND: In children with Chiari type I malformation and syringomyelia, neurosurgical posterior fossa decompression (PFD) provides clinical improvement, but whether duraplasty (incising the dura and placing a dural graft) improves outcomes is unclear. METHODS: We conducted a multicenter, cluster-randomized, controlled trial of PFD with duraplasty (PFD-D) as compared with PFD alone. Persons 21 years of age or younger with cerebellar tonsillar ectopia of at least 5 mm and a maximum syrinx diameter of 3.0 to 9.9 mm were enrolled at 38 centers. Centers were cluster-randomized: all the participants within each center underwent the same intervention. The primary outcome was surgical complications within 6 months. Secondary outcomes were clinical improvement, syrinx reduction, and repeat decompression at 10 to 24 months and the change in overall health-related quality of life at 6 to 24 months. RESULTS: A total of 162 participants were included in the trial, of whom 78 were assigned to undergo PFD-D and 84 to undergo PFD alone. The percentage of participants with complications within 6 months was 14% with PFD-D and 6% with PFD (adjusted odds ratio, 2.59; 95% confidence interval [CI], 0.86 to 7.84; P = 0.11). At 24 months, the percentage of participants with clinical improvement was 58% with PFD-D and 46% with PFD; the mean (±SD) syrinx reduction was 3.08±2.33 mm and 1.22±1.79 mm, respectively; and the percentage of participants with repeat decompression was 3% and 14%. Changes in health-related quality of life were similar in the two groups. CONCLUSIONS: The percentage of participants with surgical complications did not differ significantly between those who underwent PFD-D and and those who underwent PFD alone. Larger trials are needed to determine the relative benefits and risks of these two procedures. (Funded by the Patient-Centered Outcomes Research Institute and others; ClinicalTrials.gov number, NCT02669836.).

29 May 2026

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Systematic ReviewEvidence: Moderate
75CEBM

BMJ paediatrics open

Prevalence of dysglycemia following paediatric cardiac surgery: a systematic review and meta-analysis

BACKGROUND: Postoperative dysglycemia is a common but under-recognised complication in paediatric cardiac surgery, driven by physiologic stress, hormonal changes and cardiopulmonary bypass. Reported prevalence varies widely, and no meta-analysis has synthesised the evidence. Therefore, this study aimed to estimate the pooled prevalence of postoperative dysglycaemia and describe associated postoperative outcomes, such as intensive care unit (ICU) stay and mechanical ventilation duration. METHODS: We conducted a systematic review and meta-analysis following PRISMA 2020 guidelines and the Joanna Briggs Institute (JBI) methodology for prevalence studies. Eligible studies included paediatric patients (≤18 years) undergoing cardiac surgery reporting postoperative dysglycaemia (hyperglycaemia or hypoglycaemia). A random-effects model was used to calculate pooled prevalence and 95%CIs, with logit transformation applied to prevalence proportions and heterogeneity assessed using I² statistics. Subgroup analyses were performed by region/continent, study design, age group and glycaemic threshold. All included studies were critically appraised using the Newcastle-Ottawa Scale for observational studies and the Cochrane Risk of Bias 2 tool for randomised trials. The protocol was registered with PROSPERO (CRD420251161893). RESULTS: 22 studies involving 3864 patients were included. The pooled prevalence of postoperative dysglycemia was 68.6% (95% CI 52.8 to 81.0), with hyperglycaemia accounting for most cases (71.2%) and hypoglycaemia observed in 8.1%. Prevalence was higher in Asia and North America (~75%) than in Europe (45.2%), though not statistically significant. Studies using lower hyperglycaemia thresholds (126-139 mg/dL) reported significantly the highest prevalence (82.3%, p<0.032). The pooled mean ICU stay among dysglycemic patients was 180.3 hours (95% CI 82.3 to 279.3), and mean mechanical ventilation duration was 94.6 hours (95% CI 5.2 to 184.1). Sensitivity analyses showed that no single study disproportionately influenced the overall pooled estimates, and no publication bias was detected. The certainty of evidence assessed using the GRADE approach was moderate for overall dysglycemia prevalence. CONCLUSION: Dysglycaemia is highly prevalent following paediatric cardiac surgery, particularly hyperglycaemia, with prolonged ICU and mechanical ventilation times observed among affected patients. These findings underscore the need for vigilant perioperative glucose monitoring, standardised definitions of dysglycaemia, and evidence-based glycaemic management protocols. Future multicentre studies are warranted to establish optimal glycaemic thresholds and evaluate targeted interventions to improve postoperative outcomes in this vulnerable population.

15 May 2026

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otherEvidence: Moderate
65CEBM

European journal of pediatrics

Randomised crossover trial of neurally adjusted ventilatory assist (NAVA) for neonates with congenital diaphragmatic hernias: the NAN-C study

Retrospective studies comparing NAVA to assist control ventilation (ACV) in neonates with congenital diaphragmatic hernia (CDH) have shown that ventilatory mode may improve respiratory parameters. The aim of this study is to determine if infants with CDH studied post-operatively had a lower oxygenation index (OI) on NAVA compared to ACV. This dual-centre randomised cross-over trial compared post-operative NAVA with ACV in infants with CDH. Infants were randomised to receive either NAVA or ACV first in a 1:1 ratio for a 4-h period. At the end of each 4-h period, blood gas analysis was performed and the OI calculated. The inspired oxygen concentration (FiO2), the peak inflation (PIP), and mean airway pressure (MAP) were averaged from the last 5 min on each mode. Eleven infants were randomised. Nine infants completed the trial. with median gestational age of 38 (range 34.6-39.3) weeks and median postnatal age of 7 (range 5-36) days. Eight had left-sided CDH, six had patch repair and two had thoracoscopic repair. The mean OI after 4 h on NAVA was 3.9 ± 1.8 compared to 5.9 ± 1.61 on ACV (p = 0.008). The peak Edi (6.05 ± 4.5 versus 9.86 ± 7.3 µV, p = 0.028), PIP (17 ± 6.3 versus 22 ± 5.3 cmH2O, p = 0.017), and MAP (8.7 ± 2.6 versus 11.1 ± 1.8 cmH2O, p = 0.008), expiratory tidal volume (5.06 ± 0.71 versus 9.86 ± 1.29 ml/kg, p = 0.043) were lower on NAVA versus ACV. Two infants were randomised, but the trial was stopped due to a low Edi signal.Conclusion: NAVA compared to ACV improved oxygenation postoperatively in infants with CDH. On NAVA, infants had lower oxygen indices, peak Edi, expiratory tidal volume and peak and mean airway pressures.

10 Apr 2026

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