Research Appraisals
Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.
Showing 4 appraisals
PloS one
Long term evaluation of the safety and efficacy of local cooling anesthesia during intravitreal injections: The COOL-2 Trial
BACKGROUND/OBJECTIVE: To evaluate the safety and effectiveness of a medical device providing cooling anesthesia to the eye as local anesthesia for intravitreal (IVT) injections. SUBJECTS/METHODS: As a multicenter, open label, dose escalation clinical trial, subjects receiving at least 3 IVT injections in the study eye were recruited to participate. All patients received subconjunctival lidocaine as their anesthesia for previous IVT injections. Subjects receiving IVT injections were assigned (non-randomized) to four groups in which the cooling device was applied to the conjunctiva at the location of the intravitreal injection: Group 1: -10˚C for 20 seconds; Group 2: -15˚C for 10 seconds; Group 3: -15˚C for 15 seconds; and Group 4: -15˚C for 20 seconds. The primary outcome was pain during IVT injection assessed by a visual analog scale (0-10). RESULTS: Eighty subjects were enrolled at 2 sites. The mean number of prior IVT injections was 20.3 for Group 2 and 15.0 for Group 3. Pain was significantly less for the 10 second vs the 15 second application (2.2 vs 3.6, p = 0.0255). The mean pain score was lower for Group 2 (-15°C for 10 seconds) ranging a score of 1.0 to 2.9 across the study visits, compared with Group 3 (-15°C for 15 seconds) with a mean range of 3.2 to 5.2 across the study visits. Treatment order (visit) significantly decreased by 0.10 pain units per visit (p = 0.0002). Punctate epithelial erosions (PEE) were reported in 20 of 56 eyes (35.7%) in Group 2, none were reported in Group 3. CONCLUSION: Cooling anesthesia device reduced the severity of pain associated with IVT injection during the procedure, although mild and transient PEE may be associated with treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03956797.
13 June 2026
Read appraisal →Clinical oral investigations
Effectiveness of BRIX3000 for chemo-mechanical caries removal: a systematic review and meta-analysis of time and pain outcomes
AIMS: This systematic review was conducted to critically assess and statistically synthesise data from all available clinical studies on this topic. This study focused on the efficacy and safety of this agent (BRIX3000), the time required for caries removal, and the pain experienced by patients during the procedure, to provide clinicians and researchers with clear evidence on whether BRIX3000 is genuinely effective. MATERIALS AND METHODS: Electronic literature searches were performed using PubMed, Scopus, and Web of Science to collect eligible randomised clinical trials that had evidence regarding the efficacy of BRIX3000 for chemo-mechanical caries removal in comparison with the conventional rotary instruments and other atraumatic restorative treatment (ART) methods. The selected studies included children and adults of both sexes, with no age or gender preference, who had dentinal carious lesions in primary or permanent teeth without pulpal involvement. RESULTS: Nine randomised trials (eight in paediatric and one in adult populations) were included. Pooled analyses indicated that BRIX3000 was associated with a longer mean caries removal time than control techniques (MD 4.58 min, 95% CI 2.45 to 6.70; p < 0.0001; I² = 96%) and with lower pain scores on the Wong-Baker FACES scale among paediatric patients (MD - 2.50, 95% CI - 4.37 to - 0.62; p = 0.009; I² = 92%). Complete caries removal did not differ significantly between groups in either the paediatric (OR 0.45, 95% CI 0.02 to 8.34; p = 0.59) or adult (OR 0.73, 95% CI 0.15 to 3.49; p = 0.69) subgroup. All pooled estimates exhibited substantial heterogeneity, and the adult evidence comprised only two trials. Most included studies were judged to be at low overall risk of bias on the RoB 2 tool. CONCLUSION: Within the limits of substantial heterogeneity, short follow-up, and a small adult evidence base, BRIX3000 may represent a useful chemo-mechanical alternative - particularly in paediatric and anxiety-prone patients - at the cost of a modest increase in procedural time. Adequately powered trials with longer follow-up are required to confirm these preliminary findings. CLINICAL RELEVANCE: Our results indicate that BRIX3000 can be a viable option for patients with extensive fear of conventional methods, as well as for the paediatric population.
7 June 2026
Read appraisal →World journal of urology
Clinical and procedural factors influencing ureteral stent dwell time and removal methods after endourological procedures: a systematic review.
INTRODUCTION: Ureteral stents are routinely used following endourological procedures to ensure adequate drainage and prevent obstruction. However, stent-related morbidity remains common, and optimal stent dwell time and removal methods are not well defined. This systematic review aimed to evaluate clinical and procedural factors influencing ureteral stent dwell time and the methods used for stent removal after endourological interventions. METHODS: A systematic review was conducted in accordance with PRISMA guidelines and registered on PROSPERO. MEDLINE and Embase were searched from inception to October 2025. Randomized controlled trials and comparative observational studies evaluating ureteral stent dwell time and/or removal methods in adults undergoing endourological procedures were included. Risk of bias was assessed using RoB 2 and ROBINS-I tools. RESULTS: Thirty-two studies encompassing 4,373 patients were included. Reported stent dwell times varied widely, most commonly ranging between 10 and 14 days in uncomplicated cases, with longer durations associated with increased rates of encrustation and removal difficulty. Removal techniques included rigid cystoscopy (48.7%), flexible cystoscopy (19.9%), extraction strings (23.5%), and device-assisted methods (7.9%). Less invasive approaches, particularly flexible cystoscopy and extraction-string removal, were consistently associated with reduced pain scores and improved patient comfort, although extraction strings carried a small risk of premature dislodgement. CONCLUSIONS: While practice patterns vary, the evidence suggests that a 10-14 day dwell time might be the optimal window to balance healing with the prevention of encrustation. Less invasive removal approaches, particularly flexible cystoscopy and extraction-string techniques, were generally associated with lower pain scores and high procedural success rates in selected patients. While these methods are safe and better tolerated, extraction strings carried a small, reproducible risk of premature dislodgement. High-quality prospective studies are needed to define determinant-based, individualized stent management strategies.
10 May 2026
Read appraisal →Scientific reports
Effectiveness of intracanal cryotherapy in reducing post-endodontic pain in irreversible pulpitis: a systematic review and meta-analysis
Irreversible pulpitis is characterized by persistent inflammation and moderate to severe pain, often requiring pharmacological or adjunctive strategies for postoperative management. Intracanal cryotherapy has emerged as a simple, cost-effective technique to mitigate this pain by utilizing cold-induced physiological responses. This systematic review and meta-analysis aimed to evaluate the clinical evidence regarding the effectiveness of intracanal cryotherapy in reducing postoperative pain in teeth with irreversible pulpitis. Electronic searches were conducted in PubMed, Web of Science, Cochrane, and Scopus up to October 2025. Randomized controlled trials (RCTs) comparing intracanal cryotherapy to conventional endodontic treatment. Two reviewers independently screened studies, extracted data, and assessed risk of bias using RoB 2. Random-effects meta-analysis was performed using SMD for pain levels at 6, 12, 24, 48, and 72 h. Twelve RCTs were included; nine were meta-analyzed. Cryotherapy significantly reduced pain at 6 and 12 h but not later time points. Intracanal cryotherapy appears to be a safe and inexpensive adjunct that is associated with reduced early postoperative pain, with the most consistent effect observed within the first 6-12 h. Heterogeneity and short follow-up periods. Cryotherapy reduces early postoperative pain only.Registration: PROSPERO CRD420261295239.
27 Apr 2026
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