Evaluating the agreement between children and their parents on dental pain in children using the self-reported method.

BACKGROUND: Having preschool children evaluate their dental pain can provide an additional insight into pain diagnoses and improve patient-centered care. This study aimed to evaluate the agreement between self-reported dental pain by preschoolers and their parents' report (proxy measure). DESIGN: This cross-sectional study was conducted with children aged 4 to 6 years, and with one of their parents. Dental pain was reported using the Simplified Faces Pain Scale (S-FPS) and administered before the dental consultation. Dental pain was assessed using closed-ended questions, and a three-face scale was used to determine pain severity. The kappa and weighted kappa tests were used to evaluate the agreement between the children's self-report and their parents' report. RESULTS: A total of 198 child-parent dyads participated. Current child dental pain was reported by 44.4% of the children and 36.9% of the parents. Severe pain was reported most frequently between children (17.1%) and parents (16.2%). The agreement on the severity of dental pain ranged from substantial (children aged 6 years and parents: weighted kappa = 0.372) to moderate (4-year-olds: 0.412; 5-year-olds: 0.453). CONCLUSION: Children and parents agreed on the child's dental pain. The use of the S-FPS among younger children appears valid and feasible for assessing dental pain.

Parents' satisfaction with paediatric dental treatment under sedation: A cross-sectional study.

BACKGROUND: Patient-reported outcomes are under-investigated in the field of paediatric dental sedation. AIM: To evaluate the satisfaction of parents/guardians with their children's dental sedation, compare it to the dentist's satisfaction, and identify associated factors. DESIGN: This study was performed with parents/guardians of young children treated under sedation and dentists. Participants' satisfaction was measured using the visual analogue scale (0-100). Child's behaviour was classified using the Ohio State Behavioural Rating Scale. Other information was collected during interviews and from patient charts. The Spearman's, Mann-Whitney and Kruskal-Wallis tests were performed (P < .05). RESULTS: A total of 167 parents/guardians and ten dentists participated in the study. Protective stabilisation and atraumatic restorative treatment (ART) were used in 69.9% and 51.5% appointments, respectively. The parents/guardians (median: 91 [25-75 percentile: 75-96]) and dentists (76 [23-98]) were satisfied. Parental/guardian satisfaction was higher than dentist satisfaction (P ≤ .001). Parental/guardian satisfaction was positively correlated with quiet child behaviour (r = 0.347, P ≤ .001) and was associated with the non-use of protective stabilisation (P ≤ .001), no previous toothache (P = .019), and the use of ART (P = .018). CONCLUSION: The participants were satisfied with treatment under sedation. Parents/guardians were more satisfied, especially, when the child had cooperative behaviour.

Sedation versus protective stabilization for dental treatment of children with caries and challenging behavior at the dentist (CHOOSE): a study protocol for a non-randomized clinical trial.

BACKGROUND: There is a lack of evidence on the effectiveness of moderate sedation in pediatric dentistry, compared to protective stabilization, which remains routinely used in Brazil despite moral questions. This prospective non-randomized clinical trial's objective is to evaluate the effectiveness of moderate sedation, compared to the protective stabilization, in the dental care of children with dental behavior management problems. METHODS: Participants will be 152 children under seven years of age with early childhood caries (ECC) who need specialized dental treatment due to a history of challenging behavior during dental care. The interventions to be compared are moderate sedation with oral administration of ketamine and midazolam and protective stabilization. The primary endpoint will be the child's behavior during treatment assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). The secondary outcomes are (A) child's - behavior according to the visual analogue scale, anxiety, pain, and physiological stress; (B) parent's - satisfaction and anxiety; (C) family and child - impact on oral health-related quality of life (OHRQoL); (D) dentist's - satisfaction and stress; (E) procedure - adverse events of the intervention and dental treatment longevity. A cost-effectiveness analysis will be performed from the perspective of the Brazilian Unified Health System (SUS). DISCUSSION: Considering the primary outcome, this study hypothesis is that sedated children have better behavior during dental treatment than children whose behavior was managed by protective stabilization without sedation. Additionally, at the end of 12 months, we expect to identify participants' reported outcomes and objective measures related to dental behavior in early childhood. Trial registration Clinicaltrials.gov registration NCT04119180 on October 8th, 2019. https://clinicaltrials.gov/ct2/show/NCT04119180.

Determinants of parental report of dental pain and discomfort in preschool children-The Dental Discomfort Questionnaire.

BACKGROUND: Pain is a major consequence of caries, which negatively impacts the quality of life of children and their families. AIM: To analyse the parental report of dental pain and discomfort in preschool children, and to identify clinical and sociodemographic factors associated. DESIGN: This cross-sectional study involved 375 four- and five-year-old preschoolers enrolled in the city of Campo Magro public school system, along with their parents and caregivers. Parents/caregivers answered the Brazilian version of the Dental Discomfort Questionnaire (DDQ-B) and a sociodemographic questionnaire. Two examiners (kappa > 0.79) performed clinical examinations using dmf-t and pufa index. The associations were statistically analysed by univariate and multiple Poisson regression with robust variance (α = 0.05). RESULTS: The prevalence of dental pain and discomfort was 70.3% (66%-75% 95% CI). Children from non-nuclear families (PRa 1.33; 95% CI: 1.01-1.76) and whose parents presented a lower level of education (PRa 2.43; 95% CI 1.66-3.55) presented a higher prevalence of dental pain or discomfort. Considering the clinical determinants, after adjusting, only the presence of clinical consequences of untreated dental caries (pufa ≥ 1) (PRa 1.37; 95% CI 1.02-1.84) was significantly associated with higher dental pain or discomfort. CONCLUSIONS: Dental pain and discomfort were associated with socioeconomic factors and with the presence of clinical consequences of untreated dental caries.

Recommended procedures for the management of early childhood caries lesions - a scoping review by the Children Experiencing Dental Anxiety: Collaboration on Research and Education (CEDACORE).

BACKGROUND: Early childhood caries (ECC) affects millions of children up to 6 years old. Its treatment positively impacts the quality of life of children and their families. However, there is no consensus on how to treat ECC. Thus, we performed a scoping review to identify the recommended procedures for the management of ECC lesions. METHODS: A search was performed in PubMed, Scopus, The Cochrane Library, The International Guideline Library and pediatric dentistry associations around the world were contacted by email for unpublished search documents. ECC guidelines/guidance/policies were considered eligible regardless of language and publication date. RESULTS: From a total of 828 references, 52 full-text articles were assessed for eligibility and 22 included in the scoping review. We found different procedures recommendations for the management of ECC lesions. For incipient lesions, minimally invasive methods such as professional fluoride and cariostatic (silver diamine) applications, as well as surveillance were recommended. If restoration was required, the recommended materials were glass ionomer cement, composite resin, amalgam and stainless-steel crown. Interim restorations and Atraumatic Restorative Treatment (ART) were also recommended. Extractions have been suggested for teeth with lesions with pulpal involvement, depending on the child's behaviour and other clinical conditions. CONCLUSIONS: Non-operative procedures, restorative and extraction were recommended for the management of ECC, depending on the extent of the lesions. There is no difference between different management guidelines/guidance/policies for ECC lesions.

Developmental defects of enamel in the deciduous incisors of infants born preterm: Prospective cohort.

OBJECTIVE: Developmental defects of enamel (DDE) in preterm infants still require clarification and may favour dental caries, lower food intake and greater difficulty with weight-height gain. We evaluated factors associated with DDE in preterm infants. SUBJECTS AND METHODS: In this prospective cohort study, we monitored 54 prematurely born infants from birth to 24 months of age. Trained and calibrated dentists examined the oral cavity of these children to identify and categorize DDE. Information on perinatal variables was collected from the infants' medical records and interviews with their mothers. The data were analysed using Student's t test, a chi-squared test and Pearson's product-moment correlation coefficient. RESULTS: A total of 46.3% of the 54 children presented DDE, which was observed more frequently in the left hemiarch in children born extremely (<28 weeks of gestation) or very preterm (28 to <32 weeks; RR = 2.2; 95% CI 1.3-3.6), with very low birthweight (<1,500 g; RR = 2.0; 95% CI 1.1-3.5), who were admitted to the neonatal intensive care unit (RR = 1.3; 95% CI 1.0-1.7), and who were intubated (RR = 1.6; 95% CI 1.1-2.2). CONCLUSIONS: The high incidence of incisor enamel defects, particularly on the left side, was related to higher risk prematurity and to local trauma from intubation.

Impact of untreated dental caries severity on the quality of life of preschool children and their families: a cross-sectional study.

PURPOSE: Untreated dental caries is a persistent oral problem among preschool children. Although there is vast evidence regarding the impact of dental caries on oral health-related quality of life (OHRQoL) in this age group, evidence on the impact of untreated caries severity is scarce. The purpose of this study was to investigate the impact of untreated caries severity on the OHRQoL of preschool children and their families. METHODS: A cross-sectional study was conducted with 563 individuals in the city of Goiania, Brazil. Data were collected through interviews with parents/caregivers and clinical examinations of their children. The OHRQoL was measured by the Brazilian version of the Early Childhood Oral Health Impact Scale. Untreated dental caries severity was assessed using validated indices. Other independent variables were socioeconomic, toothache prevalence, and the questionnaire respondent. Statistical analysis involved bivariate comparisons and Poisson regression analyses. RESULTS: A higher prevalence of impact on OHRQoL was found among preschool children with untreated dental caries with clinical consequences (PR 1.31; 95% CI 1.01-1.70) compared to those without caries; those aged 5 years (PR 1.47; 95% CI 1.18-1.82), compared to those aged two; and those with a toothache (PR 1.54; 95% CI 1.34-1.76), compared to those without toothache. Moreover, fathers (PR 0.71; 95% CI 0.55-0.92) and other respondents (PR 0.70; 95% CI 0.52-0.96) perceived less impact on the OHRQoL in comparison to mothers. CONCLUSIONS: Severe untreated dental caries with clinical consequences had a negative impact on the children's OHRQoL, regardless of toothache and socioeconomic factors.

Cognitive behaviour therapy for anxious paediatric dental patients: a systematic review.

BACKGROUND: There is a paucity of evidence about cognitive behaviour therapy in the management of dentally anxious children. AIM: To systematically review evidence of the effectiveness of cognitive behaviour therapy for children with dental anxiety or dental phobia. DESIGN: Clinical trial registries, grey literature, and electronic databases, including The Cochrane Library, EMBASE, PubMed, Scopus, Web of Science, LILACS/BBO, and PsycINFO, were searched (April 2018). The reference lists of relevant studies were hand-searched. Randomised controlled trials that evaluated the effects of cognitive behaviour therapy on dental anxiety or on acceptance of dental treatment in dental patients up to 18 years were included. Two trained and calibrated reviewers performed the study selection and risk of bias assessment. The quality of the evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Six studies with a total of 269 patients, aged 41 months to 18 years, were included. Cognitive behaviour therapy decreased level of anxiety compared to control groups and improved cooperation/behaviour, although the quality of the evidence was low. CONCLUSIONS: Cognitive behaviour therapy produces better anxiety reduction than diverse behavioural management techniques but the evidence was of low quality and further studies in children are needed.

Association of breastfeeding and malocclusion in 5-year-old children: Multilevel approach.

BACKGROUND: Breastfeeding plays an important role in child health, including the development of normal dental occlusion, but large epidemiological findings on the association breastfeeding-malocclusion are lacking. AIM: To investigate the association between the proportion of breastfed children in the city level and the prevalence of malocclusion in the primary dentition at age 5. DESIGN: This cross-sectional analysis used data from national population surveys on oral health and on breastfeeding practices. Data refer to 5278 5-year-old children and 44 Brazilian towns. Information on malocclusion and individual sociodemographic characteristics were obtained from the 2010 Brazilian Oral Health Survey. Breastfeeding rates during the first year of life were extracted from the Breastfeeding Prevalence Survey in Brazilian Towns. Population sociodemographic data were analysed as confounder. Multilevel Poisson analyses were performed. RESULTS: Malocclusion prevalence was 63.3%. Towns exhibiting higher prevalence of breastfeeding among 9- to 12-month-olds presented lower prevalence of malocclusion among children at age 5 (PR 0.98; 95% CI 0.98-0.99). CONCLUSIONS: Lower prevalence of malocclusion among 5-year-old children was associated with a higher proportion of children breastfed at ages 9 to 12 months at a city level, regardless of sociodemographic factors. These findings highlight the importance of encouraging breastfeeding during a child's first year.

Caries severity declined besides persistent untreated primary teeth over a 22-year period: Trends among children in Goiânia, Brazil.

BACKGROUND: Evidence of time trends in early childhood caries in low- and middle-income countries in the second decade of the year 2000 is scarce. AIM: To assess the trends in early childhood caries prevalence and severity in 2- to 5-year-old children over a 22-year period (1993-2015) in Goiânia, Midwest Brazil. Additionally, we aimed to investigate the changes regarding affected dental arches and teeth. DESIGN: A time-lag analysis of trends in caries was carried out using data from three cross-sectional studies based on the World Health Organization diagnostic criteria, in 1993 (N = 1362), 2001 (N = 1620), and 2015 (N = 548). RESULTS: Caries prevalence declined from 45.1% in 1993 to 29.0% in 2015. Prevalence of severe caries (dmft ≥ 6) in 2015 was nearly one-third of that found in 1993, and the SiC index (mean dmft of the highest tertile) decreased from 4.55 to 3.32. Decline was higher in the 1993-2001 than in the 2001-2015 time-lag. Posterior teeth and second molars had the greatest reductions. High proportions of untreated caries were found in all ages and survey years. CONCLUSION: There were significant changes in caries prevalence and severity, marked by a striking decline from 1993 to 2001, followed by a less prominent decrease up to 2015, and high levels of untreated caries.

Does sevoflurane add to outpatient procedural sedation in children? A randomised clinical trial.

BACKGROUND: There is little evidence concerning the effect of sevoflurane in outpatient procedural sedation, especially in children. We hypothesised that the addition of sevoflurane to a sedation regimen improves children's behaviour with minimal adverse events. METHODS: This is a randomised, triple-blind clinical trial conducted on an outpatient basis. Participants were 27 healthy children aged 4 to 6 years, who previously refused dental treatment with non-pharmacologic methods. All participants received oral midazolam (0.5 mg/kg, maximum 20 mg) and oral ketamine (3 mg/kg, maximum 50 mg) and, in addition: Group MK - 100% oxygen; Group MKS - inhalational sevoflurane at a sedative dose (final expired concentration between 0.3 and 0.4%). Dental appointments were video recorded for assessment of the children's sleep patterns, crying, movements, and overall behaviour during the procedure with the Houpt scale. Intra- and post-operative adverse events were systematically reported. Data were analysed by bivariate analyses in the IBM SPSS v. 19, at a significance level of 5%. RESULTS: MK (n = 13) and MKS (n = 14) did not differ regarding the Houpt scores (P > 0.05), but 53.8% of children in the MK group showed hysterical and continuous crying at the time of the local anaesthesia injection, compared to 7.1% of children in the MKS group (P = 0.01; phi = 0.5). There was a trend toward less crying and movement over time during the dental appointment in the MKS group (P = 0.48). Minor adverse events were observed in 10 MK children and 4 MKS children (P = 0.01). CONCLUSIONS: The addition of sevoflurane to oral midazolam-ketamine improved the children's crying behaviour during local anaesthetic administration, and did not increase the occurrence of adverse events. TRIAL REGISTRATION: Clinical Trials NCT02284204 . Registered 5 October 2014.

Mother-child interactions and young child behavior during procedural conscious sedation.

BACKGROUND: As many preschoolers are not able to cooperate with health-related invasive procedures, sedation can help with the child's comfort and allow the intervention to be done. It is scarcely known how parents affect children's behavior during dental treatment under conscious sedation. The aim of this exploratory study was to analyze the association between mother-child interactions in day-to-day family life and preschool children's behavior during dental treatment under conscious sedation. METHODS: This cross-sectional study included 27 children aged 2-6 years and their mothers. The children's behavior during dental treatment under conscious sedation was verified through the analysis of videos and using an observational scale. Social skills of mothers were verified through interviews using the Parental Educative Social Skills Interview Script (RE-HSE-P); the sum of the scores allowed the establishment of the categories "clinical" and "non-clinical". We presented descriptive analyses and bivariate associations. RESULTS: Children's overall behavior during dental sedation was: very poor (n = 2), poor (n = 1), regular (n = 2), good (n = 9), very good (n = 9) and excellent (n = 4). Social skills varied: parental educational social skills (n = 24 clinical vs. n = 3 non-clinical); child social skills (n = 20 vs. n = 7), context variables (n = 15 vs. n = 12), negative educational practices (n = 12 vs. n = 15), child behavior problems (n = 7 vs. n = 20). There was no association between child behavior under sedation and social skills categories (P > 0.05). CONCLUSIONS: The majority of interviewed mothers reported issues in parental educational social skills and child social skills, which did not affect the outcomes of the children's behavior during the procedural conscious sedation.

Professional dental prophylaxis increases salivary cortisol in children with dental behavioural management problems: a longitudinal study.

BACKGROUND: Dental procedures may cause stress and increase the salivary cortisol levels. It is important to known if apparently simple procedures such as professional dental prophylaxis at low speed (DP) are stressful for children with dental behaviour management problems (DBMP) to help with behaviour guidance strategies. This longitudinal study aimed to evaluate if DP changes a physiological marker of stress (salivary cortisol) in children with DBMP who were referred to dental treatment under sedation. METHODS: One paediatric dentist carried out a DP with rubber cup and pumice followed by dental examination in 39 children aged 2-5 years, prior to the dental sedation appointment. Children's saliva was collected at three different moments: upon waking (UW), on arrival at the dental office reception area (RA) and 25 min after the dental prophylaxis (DP). The saliva samples were analysed using an enzyme immunoassay kit. The Wilcoxon test was used in paired comparison (P < 0.05). RESULTS: Salivary cortisol levels decreased from UW (0.34; 0.15-0.54) to RA (0.14; 0.08-0.56) (P = 0.019) and increased from RA to DP (0.25; 0.06-1.48) (P = 0.008). Higher salivary cortisol levels were observed at DP when compared to RA in children who did not have previous dental treatment (P = 0.007), had toothache (P = 0.006), presented some protest behaviour during DP (P = 0.008), or needed protective stabilisation by parents for the dental examination (P = 0.005). CONCLUSIONS: Paediatric dentists should be aware that even simple procedures such as professional dental prophylaxis are related to stress in young children.

One-year follow-up of Atraumatic Restorative Treatment(ART) for dental caries in children undergoing oncohematological treatment: a pragmatic trial.

BACKGROUND: The oral condition in children undergoing oncohematological treatment can have a negative impact on the course of disease. Little is known about survival of tooth restorations in these patients. The aim of this study was to evaluate the longevity of restorations and sealants performed by Atraumatic Restoration Treatment (ART) in patients undergoing oncohematological treatment. METHODS: ART single surface restorations and sealants were performed in the experimental group (E), which comprised children (2-13 years old) undergoing oncohematological treatment, and in the control group (C), in which patients did not undergo such treatment. The same examiner evaluated the ART at 1, 3, 6 and 12 months after preparation, using the same criteria for restorations and sealants. ART was successful if the sealant or restoration did not need a repair in the follow-up assessment. Descriptive, bivariate and Cox's proportional hazard analyses were performed at a significance level of 5 %. RESULTS: The two groups, one including 24 children (E) and the other 14 children (C), received 101 and 52 ART procedures, respectively. The success rates were 95.0 % (E) and 100 % (C) at 1 month (P = 0.233); 81.2 % (E) and 92.3 % (C) at 3 months (P = 0.009); 72.2 % (E) and 80.8 % (C) at 6 months (P = 0.050) and 48.5 % (E) and 73.1 % (C) at 12 months (P = 0.001). The final Cox's regression model for occurrence of ART failure needing repair did not show differences between groups (E: OR = 1.6, 95 % CI 0.8-2.9); primary teeth had a shorter survival than permanent teeth (OR = 2.1, 95 % CI 1.2-3.7). CONCLUSIONS: Oncohematological treatment did not interfere with the longevity of ART restorations and sealants, which suggests the potential use of this technique in children undergoing chemotherapy. TRIAL REGISTRATION: Brazilian Clinical Trials Registry (REBEC) RBR-2c3c52. Registered 5 June 2014. http://www.ensaiosclinicos.gov.br/rg/RBR-2c3c52/.

Screening preschool children with toothache: validation of the Brazilian version of the Dental Discomfort Questionnaire.

BACKGROUND: The Dental Discomfort Questionnaire (DDQ) is an observational instrument intended to measure dental discomfort and/or pain in children under 5 years of age. This study aimed to validate a previously cross-culturally adapted version of DDQ in a Brazilian children sample. METHODS: Participants included 263 children (58.6% boys, mean age 43.5 months) that underwent a dental examination to assess dental caries, and their parent that filled out the cross-culturally adapted DDQ on their behalf. Exploratory factor analysis (principal component analysis form) and psychometric tests were done to assess instrument's dimensionality and reliability. RESULTS: Exploratory factor analysis revealed a multidimensional instrument with 3 domains: 'eating and sleeping problems' (Cronbach's alpha 0.81), 'earache problems' (alpha 0.75), and 'problems with brushing teeth' (alpha 0.78). The assessment had excellent stability (weighted-kappa varying from 0.68 to 0.97). Based on the factor analysis, the model with all 7 items included only in the first domain (named DDQ-B) was further explored. The items and total median score of the DDQ-B were related to parent-reported toothache and the number of decayed teeth, demonstrating good construct and discriminant validities. CONCLUSIONS: DDQ-B was proven a reliable pain assessment tool to screen this group of Brazilian children for caries-related toothache, with good psychometric properties.

Impact of dental sedation treatment on the oral health-related quality of life of distressed young children: A secondary analysis of a randomized clinical trial.

INTRODUCTION: Little is known regarding the impact of dental treatment under sedation on distressed young children's oral health-related quality of life (OHRQoL). AIM: To evaluate the impact of dental treatment under sedation on the OHRQoL of children and their families. METHODS: Caregivers of two-to-six-year-old children answered the Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS): (1) before treatment under sedation (T0), (2) two weeks (T1) and (3) 3 months after the completion of treatment (T2). A global transition judgment was included in the posttreatment evaluations to determine the perception of changes in OHRQoL after dental treatment. Bivariate analysis was performed. Changes in scores and effect sizes (ES) were calculated. RESULTS: Reductions were found at both posttreatment evaluations in the total B-ECOHIS scores (median [25th-75th percentile] at T0: 14 [9.8-21.7]; T1: 2.0 [0.0-5.1]; T2: 2.0 [0.0-6.7]); "child impact" section (T0: 8.8 [4.0-13.1]; T1: 0.0 [0.0-2.2]; T2: 0.0 [0.0-4.3]) and "family impact" section (T0: 6.0 [4.0-8.5]; T1: 0.0 [0.0-2.0]; T2: 0.0 [0.0-2.0]) (≤0.001; large ES). In 92.3% of cases at T1 and 88.3% at T2, caregivers reported that their child's oral health improved considerably. CONCLUSION: Dental treatment under sedation significantly improved the OHRQoL of the children and their families.

Oral Health Education for Children: Development of a Serious Game with a User-Centered Design Approach.

Background: Children can learn efficiently with well-designed serious games. The use of applications to promote health has proliferated, but there is a lack of scientific studies on educational games in oral health. Materials and Methods: We developed the Brazilian version of a British and Jordanian oral health education game for children from the perspectives of Brazilian specialists and users. This descriptive study, with a qualitative and quantitative approach, comprised three phases: I-Experts' discussion of the appropriateness of the previous version of the game to Brazil; II-Development of the first Brazilian version of the game; and III-Evaluation of the first version with 15 children from 4 to 8 years of age. Results: In Phase I, the specialists agreed with the development of the Brazilian version of the game, with minor adjustments on: advice on eating; advice on oral hygiene habits, users' age group, game characters, and game purpose. Phase II: a version with a few changes in images and recommendations, written and spoken in Brazilian Portuguese. Phase III: The global average of correct answers in the game's tasks was 75.3%, ranging from 50.0% to 100%. Children reported having fun with the game, and most understood the content and its interface; their parents found the information relevant and enjoyed the gameplay with their children. Conclusions: The Oral Health Education Game offered basic information for preventing dental caries to Brazilian children aged 4-8 years old in an interactive and fun way; it could support professionals in improving oral health education.

Mothers' perceptions of their child's enrollment in a randomized clinical trial: poor understanding, vulnerability and contradictory feelings.

BACKGROUND: Little is known about the views of mothers when their children are invited to participate in randomized clinical trials (RCTs) investigating medicines and/or invasive procedures. Our goal was to understand mothers' perceptions of the processes of informed consent and randomization in a RCT that divided uncooperative children into three intervention groups (physical restraint, sedation, and general anesthesia) for dental rehabilitation. METHODS: This is a qualitative study based on semi-structured interviews with mothers accompanying children under 3 years old presenting severe early childhood caries. Their responses were analyzed using content analysis. RESULTS: We identified one major theme from 15 mothers' responses - "Understanding of, attitudes toward, and feelings about consenting to participate in a RCT involving advanced behavior guidance techniques and about randomization" - that was derived from the following subcategories: confusion in defining techniques, questions after signing the consent form, lack of knowledge about the techniques, acceptance or questioning of the drawing, sharing responsibility with the child during the drawing, and feelings of faith in God, fear, powerlessness to choose, and relief from or an increase in pressure. CONCLUSIONS: Despite mothers' misunderstanding, vulnerability, and contradictory feelings, they were willing to overlook their thoughts in order to complete their children's dental treatment.

Combined oral midazolam-ketamine better than midazolam alone for sedation of young children: a randomized controlled trial.

BACKGROUND. There is a lack of clinical trials on paediatric dental sedation. AIM. We investigated whether young children's behaviour improves during dental treatment with oral ketamine/midazolam compared with midazolam alone or no sedation. DESIGN. Healthy children under 36 months of age, presenting early childhood caries were randomly assigned to receive protective stabilization plus: combined oral midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (MK), or oral midazolam (1.0 mg/kg) (MS), or no sedative (PS). One observer scored children's behaviour using the Ohio State University Behavior Rating Scale (OSUBRS) at determined points in a dental exam (no sedative) and treatment session. Data were analysed using nonparametric bivariate tests. RESULTS. Forty-one children were included. In the dental exam session, the sum of OSUBRS scores was similar for the three groups (P = 0.81). In the treatment session, the MK produced more cooperative behaviour than MS and PS (P = 0.01), longer sessions (P = 0.04), and a pattern of homogeneous OSUBRS scores from the reception area (before sedative administration) to the end of the session (P = 0.06). No immediate and post-discharge side effects were observed in groups MK and MS. CONCLUSIONS. The combination of oral midazolam and ketamine is efficacious for guiding the behaviour of children under 3 years old.

Post-discharge adverse events following pediatric sedation with high doses of oral medication.

OBJECTIVE: To compare the occurrence of post-discharge adverse events in children having received a high dose of either chloral hydrate (CH) or midazolam (MZ) during outpatient dental treatment. STUDY DESIGN: A repeated-measures study design was carried out with 42 children treated at a sedation center. The sample comprised 103 dental sedation sessions among 22 male and 20 female patients, 1-8 years old, receiving either MZ (1.0-1.5 mg/kg) or CH (70.0-100.0 mg/kg). During treatment, a single observer recorded intraoperative adverse events. Twenty-four hours later, the observer called the child's main caregiver seeking information on further adverse events. Data analysis involved descriptive and bivariate statistics and the general estimating equation for repeated measures. RESULTS: The most common intraoperative and post-discharge adverse events were hallucination (3.9%) and excessive sleep (41.9%), respectively. The chance of the occurrence of an adverse event following oral pediatric sedation was lesser among the children who received MZ than those who received CH (OR: 0.09; 95% CI: 0.01-0.88). CONCLUSIONS: High doses of CH were associated with post-discharge adverse events in children having undergone pediatric dental sedation, whereas high doses of MZ were not associated with these events in pediatric patients.