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Lacerations are the most common traumatic reason for children to visit an emergency department (ED), accounting for almost half of all procedures performed. Children experience considerable distress during laceration repair, despite routine application of local anesthetic. Pharmacologic anxiolysis may mitigate the negative practice of forcefully restraining a child, however, evidence for the most effective agent is lacking. We aim to determine the most effective anxiolytic agent for laceration repair in children. This is a multicentre, phase III, three-arm, adaptive, randomized, open-label, trial. We will include children 2-12 years with a single laceration requiring suture repair in the ED. Participants will be randomized to receive intranasal dexmedetomidine (IND) 3 mcg/kg, intranasal midazolam (INM) 0.4 mg/kg, or inhaled 50% nitrous oxide (N2O). The primary outcome is the weighted mean anxiolysis score using the Observational Scale of Behavioral Distress - Revised (OSBD-R) from initial positioning to tying of the last suture. Secondary outcomes include need for additional anxiolytic, need for physical restraint, adverse events (AEs), and delayed maladaptive behaviors. The primary analysis will be conducted by intention-to-treat. Results will report posterior means, standard deviations (SDs), and 95% high density posterior credible intervals for Total Distress Score on the OSBD-R. We will rank interventions based on the probability that an intervention is superior (Pbest) and the Surface Area Under the Cumulative Ranking Curve (SUCRA) to indicate relative anxiolytic efficacy. The mean difference in Total Distress Score and secondary outcomes will be estimated using Bayesian models. Ethics approval will be obtained from institutional review boards of the participating sites. Informed consent will be obtained from guardians of all participants in addition to assent from all participants. Study data will be submitted for publication. Clinicaltrials.gov NCT05383495.

Background Surgical glue has been used in several body tissues, including perineal repair, and can benefit women. Objectives To evaluate the effectiveness of n-butyl-2-cyanoacrylate surgical glue compared to the polyglactin 910 suture in repairing first- and second-degree perineal tears and episiotomy in vaginal births. Design A parallel randomised controlled open trial. Setting Birth centre in Itapecerica da Serra, São Paulo, Brazil. Participants and methods The participants were 140 postpartum women allocated into four groups: two experimental groups repaired with surgical glue ( n  = 35 women with a first-degree tear; n  = 35 women with a second-degree tear or episiotomy); two control groups sutured with thread ( n  = 35 women with a first-degree tear; n  = 35 women with a second-degree tear or episiotomy). The outcomes were perineal pain and the healing process. Data collection was conducted in six stages: (1) up to 2 h after perineal repair; (2) from 12 to 24 h postpartum; (3) from 36 to 48 h; (4) from 10 to 20 days; (5) from 50 to 70 days; and (6) from 6 to 8 months. ANOVA, Student's t, Monte Carlo, x-square and Wald tests were used for the statistical analysis. Results One hundred forty women participated in the first three stages, 110 in stage 4, 122 in stage 5, and 54 in stage 6. The women treated with surgical glue had less perineal pain ( p  ≤ 0.001). There was no difference in the healing process, but the CG obtained a better result in the coaptation item ( p  ≤ 0.001). Conclusions Perineal repair with surgical glue has low pain intensity and results in a healing process similar to suture threads. Trial registration Brazilian Registry of Clinical Trials (UTN code: U1111-1184-2507; RBR-2q5wy8o); date of registration 01/25/2018; www.ensaiosclinicos.gov.br/rg/RBR-2q5wy8/

The type of suture used to repair perineal injury may be associated with this healing process and subsequent sexual function. This study aims to assess whether the suture technique used (continuous or interrupted) has an impact on a woman’s sexual function following childbirth. A single-blind randomised clinical trial was conducted with primiparous women who had experienced a perineal injury during childbirth. A computer-generated random number table was applied to allocate women to each group. Data were collected on sociodemographic variables, variables associated with childbirth, and outcomes during the 3 months after childbirth. Mean difference was used to assess the influence of the suture type on outcomes. Multivariate analyses were carried out to adjust for unbalanced variables after randomisation. Seventy women participated in the intervention group (continuous suture) and 64 women in the control group (interrupted suture). The women in the intervention group scored high for sexual desire, adjusted mean difference (aMD) = 1.8, 95% CI = 1.1–2.6 (p < 0.001); the same happened with arousal (aMD = 1.7, 95% CI = 0.8–2.5, p < 0.001). In the intervention group, orgasm was more easily reached, aMD = 0.8, 95% CI = 0.4–1.1 (p < 0.001). Women who received a continuous suture indicated they felt less discomfort (p < 0.001). Women who had a continuous suture reported better postpartum sexual function. Trial registration: ClinicalTrials.gov NCT03825211 posted 31/01/ 2019.

Background Perineal lacerations are a very common complication of post-partum. Usually, the repair of 1st and 2nd-grade lacerations is performed after the administration of local anesthesia. Despite the great relevance of the problem, there are only a few studies about the best choice of local anesthetic to use during suturing. We performed a randomised controlled trial to evaluate the efficacy and safety of the use of a local anesthetic spray during the suturing of perineal lacerations in the post-partum. Methods We compared the spray with the standard technique, which involves the infiltration of lacerated tissues, using the NRS scale. 136 eligible women who had given birth at University Hospital of Udine were enrolled and randomly assigned to receive nebulization of Lidocaine hydrochloride 10% spray (experimental group) or subcutaneous/submucosal infiltration of mepivacaine hydrochloride (control group) during suturing of perineal laceration. Results The lacerations included 84 1st-grade perineal traumas (61.7%) and 52 2nd-grade perineal traumas (38.2%). All the procedures were successfully completed without severe complications or serious adverse reactions. There were no statistically significant differences between the two groups in terms of blood losses or total procedure time. Moreover, there were no statistically significant differences in terms of NRS to none of the intervals considered. Regarding the application of the spray in the B group, in 36 cases (52.9%) it was necessary to improve the number of puffs previously supposed to be sufficient (5 puffs). Just in 3 cases, an additional injection was necessary (4.4%). Conclusions Our study demonstrates that lidocaine spray alone can be used as a first line of local anesthetic during the closure of I-II-grade perineal lacerations, as it has comparable efficacy to mepivacaine infiltration. Trial registration The trial was recorded on https://clinicaltrials.gov . Identification number: NCT05201313. First registration date: 21/01/2022. Unique Protocol ID: 0042698/P/GEN/ARCS.

Background Laceration repairs are a common, yet distressing procedure in children. While a range of strategies is used to treat this distress, there is currently no standard of care. The Anxiolysis for Laceration Repair in Children (ALICE) trial aims to identify the most effective pharmacological agent to manage laceration repair-associated distress. This paper outlines the statistical analysis plan for the ALICE trial.  The ALICE trial is a phase III, Bayesian, open-label trial that will identify the optimal agent for reducing distress among intranasal dexmedetomidine (IND), intranasal midazolam (INM), and inhaled nitrous oxide (N 2 O). The primary outcome, distress, will be measured by the Observational Scale of Behavioural Distress – Revised (OSBD-R). Scores from the OSBD-R will be analyzed using a Bayesian mixed effects model with data-driven prior distributions. Samples from the model’s posterior distributions will be used to calculate the probability of being best statistic (P best ), which will effectively rank the interventions. The trial will also evaluate delayed maladaptive behaviours, need for additional physical restraint, adverse events, and need for additional sedation as secondary outcomes. Furthermore, the trial will determine the costs associated with achieving adequate sedation in each treatment arm. Discussion This statistical analysis plan specifies the outcomes and analyses for the ALICE trial. The ALICE trial will provide evidence for the most effective agent for reducing distress in children receiving laceration repairs. Trial registration ClinicalTrials.gov NCT05383495 . Registered on May 16, 2022. 

Background The technique used in the repair of a perineal injury resulting from childbirth could avoid discomfort and morbidity during the postpartum period. Recent studies show inconsistent results and support the need for new research with the inclusion of new health parameters not yet studied. Therefore, this study aims to evaluate if the suture technique (continuous or interrupted) has an effect on pain and other postpartum problems, incidence of incontinence (urinary and/or fecal), and the restart of sexual relations. Methods A single-blind randomized clinical trial was conducted in five hospitals in south-east Spain. The participants were primiparous women who had experienced a perineal injury during delivery (second-degree tear or episiotomy). Data was collected on sociodemographic variables, variables associated with pregnancy, labor and delivery, and the postpartum period, and outcomes during the 3 months after delivery: pain, incontinence, and restart of sexual relations. Odds ratios (OR) were calculated by binary logistic regression to assess the influence of the suture type on binary outcomes and t-test used for comparing continuous outcomes. Multivariate analyses (using logistic regression -adjusted (aOR)- and analysis of covariance) were carried out to adjust for unbalanced variables after randomization. Results A total of 70 women were included in the intervention group (continuous suture) and 64 in the reference group (interrupted sutures). A negative association was observed (aOR = 0.39; 95% CI = 0.18–0.86) between a continuous suture and the need for analgesia at 24 h postpartum. Pain experienced by the women at 24 h postpartum was assessed as 4.4 ± 0.3 compared with a score of 3.4 ± 0.3 in the group with continuous sutures ( p  = 0.011). At 15 days postpartum, women in the intervention group experienced less pain (aOR = 0.38; 95% CI = 0.18–0.80) ( p  = 0.019). Urinary sphincter incontinence was also evaluated at 15 days, with 4.3% ( n  = 3) of the women in the intervention group presenting with urinary incontinence compared with 18.8% ( n  = 12) in the control group (aOR = 0.11; 95% CI = 0.03–0.47) ( P  = 0.003). Conclusions The women who had a continuous suture repair showed lower levels of pain from delivery to 3 months after delivery and had a lower incidence of urinary incontinence at 15 days postpartum. Trial registration ClinicalTrials.gov NCT03825211 posted January 31, 2019 (retrospectively registered).

ObjectiveTo assess whether a 2 days training with experts teaching on diagnosis and repair of perineal injuries among Palestinian midwives and physicians could change their level of knowledge towards the correct diagnosis and treatment.Study designMulticentre observational study.SettingObstetric departments in 6 government Palestinian hospitals.ParticipantsAll physicians and midwives who attended the training.MethodsA questionnaire comprising of 14 questions on the diagnosis and repair of perineal tears was distributed to all participants before the training (n=150; 64 physicians and 86 midwives) and 3 months after the training (n=124, 53 and 71, respectively). Characteristics, differences of the study population and level of knowledge before and after the training were presented as frequencies and percentages. Consistency in responses was tested by estimating the p value of McNemar test.ResultsAmong physicians only 11.4% had accurate knowledge on perineal anatomy before the training compared with 78.85% after the training (p<0.001). For midwives, the corresponding numbers were 9.8% and 54.2%, respectively (p<0.001). Before the training, 5.8% of the physicians were aware that rectal examination is mandatory before and after suturing of episiotomies compared with 45.8% after the training (p<0.001). The corresponding numbers for midwives were 0% and 18% (p<0.001), respectively. Physicians knowledge of best practice of skin repair following episiotomy improved from 36.5% to 64.5% (p=0.008) and among midwives from 26.1% to 50.7% (p<0.001). Physicians knowledge of the overlap technique in the repair of full thickness external anal sphincter tears improved from 28.5% to 42.8% (p=0.05), whereas knowledge of repairing torn internal anal sphincter separately improved from 12.8% to 86.8% (p<0.001).ConclusionsImprovement in the level of knowledge on diagnosis and repair of perineal tears was observed for all physicians and midwives who attended the 2 days' expert training. Regular ongoing training will serve to maintain the newly acquired knowledge.

ObjectiveTo explore women's lived experiences of a dehisced perineal wound following childbirth and how they felt participating in a pilot and feasibility randomised controlled trial (RCT).DesignA nested qualitative study using semistructured interviews, underpinned by descriptive phenomenology.Participants and settingA purposive sample of six women at 6–9 months postnatal who participated in the RCT were interviewed in their own homes.ResultsFollowing Giorgi's analytical framework the verbatim transcripts were analysed for key themes. Women's lived experiences revealed 4 emerging themes: (1) Physical impact, with sub-themes focusing upon avoiding infection, perineal pain and the impact of the wound dehiscence upon daily activities; (2) Psychosocial impact, with sub-themes of denial, sense of failure or self-blame, fear, isolation and altered body image; (3) Sexual impact; and (4) Satisfaction with wound healing. A fifth theme ‘participating in the RCT’ was ‘a priori’ with sub-themes centred upon understanding the randomisation process, completing the trial questionnaires, attending for hospital appointments and acceptability of the treatment options.ConclusionsTo the best of our knowledge, this is the first qualitative study to grant women the opportunity to voice their personal experiences of a dehisced perineal wound and their views on the management offered. The powerful testimonies presented disclose the extent of morbidity experienced while also revealing a strong preference for a treatment option.Trial registration numberISRCTN05754020; results.

ObjectiveTo establish the feasibility of conducting a definitive randomised controlled trial (RCT) comparing the effectiveness of resuturing versus expectant management for dehisced perineal wounds.DesignA multicentre pilot and feasibility RCT.SettingTen UK maternity units from July 2011 to July 2013.PopulationEligible women with a dehisced perineal wound within 2 weeks of childbirth.MethodsThe interventions were resuturing or expectancy. Randomisation was via web or telephone, stratified by participating centre. Blinding was not possible due to the nature of the interventions. Analysis was by intention-to-treat.OutcomeThe primary outcome measure was wound healing at 6–8 weeks.ResultsThe study revealed a number of feasibility issues, particularly strong patient and clinician preference for treatment options at recruiting centres and the timing of the primary outcome measure. Thirty-four women were randomised (17 in each arm). Data from 33 women were analysed on an intention-to-treat analysis to obtain preliminary estimates of effect size. There was a difference in wound healing at 2 weeks favouring resuturing (OR 20.00, 95% CI 2.04 to 196.37, p=0.004). However, by 6–8 weeks all but one wound in both groups had healed.ConclusionsPREVIEW revealed a number of feasibility issues, which impacted on recruitment rate. These will have to be taken into account in the design of any future definitive study. In this feasibility study, resuturing was associated with quicker wound healing and women reported higher satisfaction rates with the outcome at 3 months.Trial registration numberISRCTN05754020.

Objectives To compare the efficacy of oral midazolam alone with a combination of oral midazolam and ketamine in children requiring laceration repair. Design A randomised, double-blind, placebo-controlled study. Setting Paediatric emergency department. Participants Children 1–10 years of age with lacerations requiring sedation. Interventions Using a computer-generated sequence, children were randomly assigned in blocks of four to one of two groups: oral midazolam (0.5 mg/kg) plus oral placebo and oral midazolam (0.5 mg/kg) plus oral ketamine (5 mg/kg). The allocation sequence was kept by the pharmacy staff, and the investigators were blinded to randomisation until statistical analysis of the study was completed. Main outcome measures Visual Analogue Scale (VAS) assessment by a parent and Sedation Score assessment by an investigator. Results 60 children were recruited; 29 were assigned for treatment with midazolam and 31 for the combination of midazolam and ketamine. There were no differences in basic demographics and wound characteristics between the groups. VAS assessment by a parent was 4.5±3.3 mm in the midazolam+ketamine group versus 4.4±2.7 mm in the midazolam alone group (mean difference 0.1, CI −1.9 to 1.71). Sedation Score during procedure was lower in the midazolam+ketamine group (mean difference 1.14, 95% CI 0.67 to 1.6). Intravenous sedation was required in two (6%) of the children in the midazolam+ketamine group, and in eight (27%) in the midazolam alone group. p=0.039. No clinically significant adverse effects were documented in either group. Conclusions No difference was found in pain assessment during local anaesthetic injection between the group treated with midazolam and ketamine, and the group treated with midazolam alone. The combination of oral midazolam and ketamine led to deeper sedation than midazolam alone, with less children requiring intravenous sedation. Clinical trial registration The trial was registered in www.clinicaltrials.gov as NCT01470157.