Randomized trial of a photography-aided behavioural intervention to reduce risk factors for caries and malocclusion in high-risk infants.

OBJECTIVE: To assess the efficacy of a photography-aided behavioural intervention in reducing risk factors for dental caries and malocclusion in high-risk infants. MATERIALS AND METHODS: In this randomized trial conducted in a maternity hospital, 55 mothers of recently born infants at high risk of developing oral diseases were allocated to either the intervention (n = 28) or usual care (n = 27). The intervention arm received the same usual care plus an enhanced, behaviour-oriented, photography-aided, two-stage (0 and +6 months) educational programme addressing nutritional, behavioural, lifestyle and familial factors that affect child's oral health. The primary outcome was the proportion of children classified as being at a 'low risk' of developing dental caries at the age of 12 months using a modified score based on the Caries-risk Assessment Form of the American Academy of Pediatric Dentistry. Secondary outcomes included risk factors for malocclusion, such as duration of exclusive breastfeeding, pacifier use and bottle-feeding and/or sippy cup usage. RESULTS: At 12 months, the proportion of children considered at low risk for dental caries was significantly higher in the intervention group compared to usual care (71% vs 15%, respectively, relative risk = 4.82, 95% confidence interval = 1.89-12.3, p < 0.001). The median duration of exclusive breastfeeding in the intervention group was 1.7 times higher than in the control arm (5 months vs 3 months, p = 0.03). CONCLUSION: Altogether, our findings provide evidence that a low-cost, two-stage preventive strategy using photographs to deliver a stronger visual impact might significantly reduce the incidence of risk factors for dental caries and malocclusion in 12-month-old children.

Codeine plus acetaminophen improve sleep quality, daily activity level, and food intake in the early postoperative period after photorefractive keratectomy: a secondary analysis.

PURPOSE: To determine whether codeine plus acetaminophen after photorefractive keratectomy (PRK) have beneficial effects on sleep quality, activity levels, and food intake, beyond their effect of pain relief. METHODS: We enrolled 40 patients (80 eyes) in this randomized, double-blind, paired-eye, placebo-controlled, add-on trial. Each eye was treated 2 weeks apart, and the patients were randomly allocated to receive either the placebo or the intervention (30 mg codeine and 500 mg acetaminophen) (4 times a day for 4 days). Outcomes were sleep quality, daily activity level, and food intake within 24-72 h post-photorefractive keratectomy, as measured by the McGill Pain Questionnaire. RESULTS: Sleep quality and daily activity level were inversely associated with pain scores within the first 48 h post-photorefractive keratectomy. During the intervention, patients were significantly more likely to score their sleep quality as good at 24 h (relative risk=2.5; 95% confidence interval 1.48-4.21, p<0.001) and 48 h compared to during placebo (relative risk=1.37; 95% confidence interval: 1.03-1.84, p=0.023). The probability of reporting good daily activity level at 24 and 72 hours post-photorefractive keratectomy was three times higher when patients received the intervention compared to the placebo (relative risk=3.0; 95% confidence interval: 1.49-6.15, p=0.006 and relative risk=1.31; 95% confidence interval: 1.02-1.67, p=0.021, respectively). No difference was observed in food intake. CONCLUSION: The oral combination of codeine and acetaminophen significantly improves sleep quality and daily activity level within the first 24-72 h post-photorefractive keratectomy compared to a placebo.

Codeine plus acetaminophen improve sleep quality, daily activity level, and food intake in the early postoperative period after photorefractive keratectomy: a secondary analysis / Melhora da qualidade do sono e das atividades diárias pós PRK imediato utilizando codeína com paracetamol: análise secundária de um ensaio clínico randomizado, duplo-cego e placebo-controlado

ABSTRACT Purpose: To determine whether codeine plus acetaminophen after photorefractive keratectomy (PRK) have beneficial effects on sleep quality, activity levels, and food intake, beyond their effect of pain relief. Methods: We enrolled 40 patients (80 eyes) in this randomized, double-blind, paired-eye, placebo-controlled, add-on trial. Each eye was treated 2 weeks apart, and the patients were randomly allocated to receive either the placebo or the intervention (30 mg codeine and 500 mg acetaminophen) (4 times a day for 4 days). Outcomes were sleep quality, daily activity level, and food intake within 24-72 h post-photorefractive keratectomy, as measured by the McGill Pain Questionnaire. Results: Sleep quality and daily activity level were inversely associated with pain scores within the first 48 h post-photorefractive keratectomy. During the intervention, patients were significantly more likely to score their sleep quality as good at 24 h (relative risk=2.5; 95% confidence interval 1.48-4.21, p<0.001) and 48 h compared to during placebo (relative risk=1.37; 95% confidence interval: 1.03-1.84, p=0.023). The probability of reporting good daily activity level at 24 and 72 hours post-photorefractive keratectomy was three times higher when patients received the intervention compared to the placebo (relative risk=3.0; 95% confidence interval: 1.49-6.15, p=0.006 and relative risk=1.31; 95% confidence interval: 1.02-1.67, p=0.021, respectively). No difference was observed in food intake. Conclusion: The oral combination of codeine and acetaminophen significantly improves sleep quality and daily activity level within the first 24-72 h post-photorefractive keratectomy compared to a placebo.

RESUMO Objetivo: Determinar se codeína (30 mg) mais pa­racetamol (500 mg) após ceratectomia fotorrefrativa fornece efeitos benéficos sobre a qualidade do sono, níveis de atividade e ingestão de alimentos além de seu efeito analgésico. Métodos: Quarenta pacientes (80 olhos) foram incluídos neste estudo randomizado, duplo-cego, pareado, placebo-controlado, add-on. Cada olho foi tratado com 2 semanas de intervalo, sendo aleatoriamente alocado para placebo ou intervenção (4x/dia durante 4 dias). Os resultados incluíram a qualidade do sono, atividade diária e ingestão de alimentos dentro de 24-72 horas de pós-operatório, conforme medido pelo McGill Pain Questionnaire. Resultados: A qualidade do sono e os níveis de atividade foram inversamente associados aos escores de dor nas primeiras 48 horas após o ceratectomia fotorrefrativa. Durante a intervenção, os pacientes foram significativamente mais propensos a classificar seu sono como bom em 24 horas (risco relativo=2,5, intervalo de confiança de 95%: 1,48-4,21, p<0,001) e 48 horas comparado ao placebo (risco relativo=1,37, intervalo de confiança de 95%: 1,03-1,84, p=0,023). A probabilidade de relatar bons níveis de atividade em 24 e 72 horas após ceratectomia fotorrefrativa também foi significativamente maior durante a intervenção em comparação com placebo (risco relativo=3,0, intervalo de confiança de 95%: 1,49-6,15, p=0,006 e risco relativo=1,31, intervalo de confiança de 95%: 1,02 -1,67, p=0,021, respectivamente). Nenhuma diferença foi observada entre a intervenção e placebo em relação à alimentação oral. Conclusão: A combinação de codeína e paracetamol melhorou significativamente a qualidade do sono e atividades diárias nas primeiras 24-72 horas após o ceratectomia fotorrefrativa em comparação com placebo.

Codeine Plus Acetaminophen for Pain After Photorefractive Keratectomy: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial.

BACKGROUND: Pain after photorefractive keratectomy (PRK) is significant, and the analgesic efficacy and safety of oral opioids in combination with acetaminophen has not been fully investigated in PRK trials. PURPOSE: To assess the efficacy and safety of the combination of codeine plus acetaminophen (paracetamol) versus placebo as an add-on therapy for pain control after PRK. STUDY DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Single tertiary center. METHODS: One eye was randomly allocated to the intervention, whereas the fellow eye was treated with a placebo. Eyes were operated 2 weeks apart. The participants were adults older than 20 years with refractive stability for ≥1 year, who underwent PRK for correction of myopia or myopic astigmatism. Codeine (30 mg) plus acetaminophen (500 mg) was given orally 4 times per day for 4 days after PRK. The follow-up duration was 4 months. The study outcomes included pain scores at 1 to 72 hours, as measured by the visual analog scale, McGill Pain Questionnaire, and Brief Pain Inventory, as well as adverse events and corneal wound healing. RESULTS: Of the initial 82 eyes, 80 completed the trial (40 intervention, 40 placebo). Median (interquartile range) pain scores as measured by the visual analog scale were statistically and clinically lower during treatment with codeine/acetaminophen compared with the placebo: 1 hour: 4 (2-4) versus 6 (3-6), P < 0.001; 24 hours: 4 (3-6) versus 7 (6-9), P < 0.001; 48 hours: 1 (0-2) versus 3 (2-5), P < 0.001; and 72 hours: 0 (0-0) versus 0 (0-2), P = 0.001. Virtually identical results were obtained by the McGill Pain Questionnaire and Brief Pain Inventory scales. The most common adverse events with codeine/acetaminophen were drowsiness (42%), nausea (18%), and constipation (5%). No case of delayed epithelial healing was observed in both treatment arms. CONCLUSIONS: When added to the usual care therapy, the oral combination of codeine/acetaminophen was safe and significantly superior to the placebo for pain control after PRK. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02625753.