Can live music therapy reduce distress and pain in children with burns after wound care procedures? A randomized controlled trial

Objective

Burn wound care procedures are very painful and lead to distress. Live music therapy has shown beneficial effects on distress and pain in specific pediatric patient populations. In this study we measured whether live music therapy has beneficial effects in terms of less distress and pain in children with burns after wound care procedures.

Is there a role for antimuscarinics in renal colic? A randomized controlled trial

PURPOSE: We determined whether the addition of hyoscine butylbromide (Buscopan) reduces the amount of opioid analgesia required and the need for ongoing opioid analgesia in acute renal colic. MATERIALS AND METHODS: Patients with a clinical diagnosis of acute renal colic were prospectively randomized to receive Buscopan or placebo in addition to morphine and intravenous fluids, with or without indomethacin. Observations and pain scores were recorded 15 every minutes during the first hour then hourly thereafter. Morphine was administered in 2.5 mg increments until pain relief was achieved. Recordings were ceased at 4 hours or on discharge from the emergency department, whichever occurred first. The diagnosis of renal colic was confirmed by computerized tomography. The dose of morphine (mg/kg) and the proportion of patients who required further morphine were compared between the 2 groups. RESULTS: Of the 192 patients randomized, data were available for 178 on an intent to treat basis. A total of 85 patients received Buscopan while 93 received placebo in addition to standard therapy. Patients in the Buscopan group required a median of 0.12 mg/kg of morphine while those in the placebo group received a median of 0.11 mg/kg, and this difference was not significant (p =0.4). There was also no significant difference in the proportion of patients who required additional morphine, 33% in the Buscopan group and 38% in the placebo group (p =0.5). Subgroup analysis of the 138 patients with a confirmed stone also showed no difference between the groups. CONCLUSIONS: There is no evidence that Buscopan reduces opioid requirements or the need for ongoing opioid analgesia in acute renal colic.     

The effect of training program based on health belief model on burn prevention knowledge in mothers of children aged to 1–3 years: A randomized controlled

PurposeOne of the effective models in health education is the health belief model that considers a person's behavior as a under the influence of knowledge and attitude. In the present study, we investigated the efficacy of a training program based on the health belief model in burn prevention knowledge in mothers of children aged between 1 and 3 years old.Design and methodsThis single blind randomized Control Trial study was conducted on 64 mothers with a child aged between 12 and 36 months who were referred to the Health Centers of Shiraz, Iran, in 2018. Accordingly, using cluster sampling, 4 health centers were selected and then 2 centers were assigned to the intervention group and 2 other centers to the control group by randomization. The intervention group received six sessions of training. However, in order to observe the ethical principles, the educational content was provided to the control group at the end of the present study. Both groups completed health belief model questionnaire before, after the intervention, and by passing 2 months from the intervention. The collected data were compared between the two groups using SPSS software, version 25.ResultsWe found no differences in the demographics of the two study groups (P > 0.05). Intragroup comparison in the intervention and control groups indicated a significant difference among the three intervals (both P = 0.001). As well, a difference was found between the intervention and the control groups immediately after the intervention and 2 months after the intervention (both P < 0.001). Additionally, in both groups, the relationship between mothers' knowledge score and each dimension of the health belief model was examined, which was a significant. (P = 0.001).ConclusionHealth belief model can be considered as an effective method for educating mothers in terms of the prevention of children’s burn and the increased the mothers’ knowledge.Practice implicationsThe health belief model was shown to have a good effect on educating mothers regarding child burn’s prevention. So, due to this reason, it is recommended to use this model for burn’s prevention training programs.     

Quality comparison of remote anesthetic consultation versus on-site consultation in children with sedation for a magnetic resonance imaging examination—A randomized controlled trial

Background

In the course of the corona pandemic, digital media has increasingly been used in many areas of medical practice to reduce personal contact. As it is of interest whether this can be practiced in the context of anesthesia consultations without loss of quality, we interviewed parents whose children received a cardiac or neuro magnetic resonance imaging (MRI) under sedation. Parents either received an on-site or a remote consultation conducted by an anesthesiologist. Both parents and anesthesiologist were asked to indicate their satisfaction with the respective consultation procedure in a questionnaire.

Aim

The aim of this study was to investigate if remote pre-anesthesia consultation, supported by an online video, for parents whose children are receiving MRI examinations under sedation can replace the commonly performed on-site consultation, without decreasing its quality.

Methods

In this randomized trial, a total of 200 patients were included, one half received pre-anesthesia consultation on-site and the other half was given a link to a video and pre-anesthesia consultation was conducted by phone. As a primary analysis, we compared the level of satisfaction for the general procedure, the quality of the pre-anesthesia consultation and the contact to the anesthesiologists (or parents). We further investigated the frequency of complications and the preference for a possible next informed consent.

Results

Both groups showed high levels of satisfaction. Some anesthesiologists and parents were less satisfied with the quality of on-site pre-anesthesia consultation than with the remote. In our patient cohort, there was no evidence for higher risk of complications when information was provided by telephone. Further, parents as well as anesthesiologists clearly favored the combined form of telephone information and online video. Overall, 61.2% of parents and 64% of anesthesiologists would choose this form of pre-anesthesia consultation for repeat anesthesia.

Conclusions

We did not observe that combined telephone and video decreased the quality of pre-anesthesia consultation. A remote version seems feasible for simple procedures such as sedation for MRI. Further research on this topic in other areas of anesthesia would be beneficial.     

Does frequency of resistance training affect tibial cortical bone density in older women? A randomized controlled trial

Summary

This randomized controlled trial evaluated the effect of resistance training frequency (0, 1, and 2 times/week) on cortical volumetric bone mineral density (vBMD) at the tibia in older women. There was no mean difference in change in tibial cortical vBMD in older women who engaged in resistance training (RT) one or two times/week compared with the control group over 12 months after adjusting for baseline values.

Introduction

National guidelines recommend RT two to three times/week to optimize bone health. Our objective was to determine the effect of a 12-month intervention of three different RT frequencies on tibial volumetric cortical density (CovBMD) in healthy older women.

Methods

We randomized participants to the following groups: (1) 2×/week balance and tone group (i.e., no resistance beyond body weight, BT), (2) 1×/week RT (RT1), and (3) 2×/week RT (RT2). Treatment allocation was concealed, and measurement team and the bone data analyst were blinded to group allocation. We used peripheral quantitative computed tomography to acquire one 2.3-mm scan at the 50 % tibia, and the primary outcome was CovBMD. Data were collected at baseline, 6 and 12 months, and we used linear mixed modeling to assess the effect at 12 months.

Results

We assessed 147 participants; 100 women provided data at all three points. Baseline unadjusted mean (SD) tibial CovBMD (in milligrams per cubic centimeter) at the 50 % site was 1,077.4 (43.0) (BT), 1,087.8 (42.0) (RT1), and 1,058.7 (60.4) (RT2). At 12 months, there were no statistically significant differences (?0.45 to ?0.17 %) between BT and RT groups for mean difference in change in tibial CovBMD for exercise interventions (BT, RT1, RT2) after adjusting for baseline tibial CovBMD.

Conclusion

We note no mean difference in change in tibial CovBMD in older women who engaged in RT one or two times/week compared with the control group over 12 months. It is unknown if RT of 3× or 4×/week would be enough to promote a statistically significant difference in change of bone density.     

Is intraperitoneal levobupivacaine with epinephrine useful for analgesia following laparoscopic cholecystectomy? A randomized controlled trial

BACKGROUND AND OBJECTIVE: A randomized controlled trial of patients undergoing laparoscopic cholecystectomy. To evaluate whether the instillation of levobupivacaine, with epinephrine, intraperitoneally, reduces morphine consumption; further, to consider the degree of abdominal and shoulder pain in the presence of local anaesthetic at the site of surgical incision. METHODS: Patients received a standardized procedure and were allocated randomly to receive either (a) 2.5 mg mL(-1) levobupivacaine 30 mL, with epinephrine 5 microg mL(-1), or (b) normal saline 30 mL, with epinephrine 5 microg mL(-1), to the bed of the gall bladder and above the liver, immediately before wound closure. RESULTS: Median (interquartile range) total abdominal pain during inspiration in the levobupivacaine group was significantly (P = 0.041) lower (71 (21-129) mm) than that in the placebo group (123 (71-179) mm). However, there was no significant difference between the two groups with respect to total abdominal pain at rest, right shoulder pain or the consumption of rescue morphine and rescue dihydrocodeine. There were no differences between the two groups with respect to the administration of cyclizine, total nausea and total sedation scores. In addition, the number of episodes of vomiting was not significantly different. CONCLUSIONS: Intraperitoneal administration of levobupivacaine with epinephrine is associated with modest analgesia following laparoscopic cholecystectomy.     

A randomised, controlled trial comparing the Airtraq™ optical laryngoscope with conventional laryngoscopy in infants and children

The Airtraq^? optical laryngoscope became available in paediatric sizes in the UK in May 2008. We conducted a randomised, controlled trial comparing the Airtraq with conventional laryngoscopy during routine anaesthesia in children. We hypothesised that the Airtraq laryngoscope would perform as well as conventional laryngoscopy. Sixty patients (20 infants and 40 children) were recruited. The mean (SD) intubation time using the Airtraq was longer than conventional laryngoscopy overall (47.3 (32.6) vs 26.3 (11.5) s; p = 0.002), though the difference was only significant for children (p = 0.003) and not for infants (p = 0.29). The Airtraq provided a better view of the larynx compared with conventional laryngoscopy (in infants (percentage of glottic opening scores 100 (95–100 [90–100]) vs 77 (50–90 [40–100]), respectively; p = 0.001; visual analogue scores for field of view 9.2 (9.2–9.5 [8.2–10.0]) vs 6.8 (5.1–8.0 [4.7–10.0]), respectively; p = 0.001). In children, the Airtraq provided a similar view of the larynx (percentage of glottic opening scores 100 (100–100 [40–100]) vs 100 (90–100 [50–100]), respectively; visual analogue scores for field of view 9.2 (8.6–10.0 [7.0–10.0]) vs 9.2 (8.6–10.0 [5.6–10.0]), respectively; both p > 0.05), compared with conventional laryngoscopy.     

A Pilates exercise program with pelvic floor muscle contraction: Is it effective for pregnant women? A randomized controlled trial

Aims

The aim of this study was to evaluate the effectiveness of a Pilates exercise program with pelvic floor muscle (PFM) contraction compared to a conventional intervention in pregnant women.

Methods

Fifty primiparous women, without gestational alterations, were randomized to the Pilates group (n = 25) and control group (n = 25). Interventions for both groups consisted of twice‐weekly sessions of 1 h each during the period between the 14‐16th and 32‐34th gestational weeks. The Pilates group performed a Pilates exercises program with the addition of voluntary PFM contraction. Mat‐based Pilates exercises were performed involving movement of the upper limbs, lower limbs and trunk in all sessions. The Control group walked for 10 min and performed strengthening exercises of the lower limbs, upper limbs, and trunk with resistance from an elastic band and body weight. Each woman was evaluated by an unblinded physiotherapist before and after intervention for primary (PFM strength using a manometer) and secondary (PFM strength using Oxford Scale, endurance and repeatability) outcomes. Covariance analysis (ANCOVA) was used to compare the groups using the baseline values as a covariate.

Results

Thirty‐six women were included in the analysis. There were no differences between the groups for manometry. An increase in the PFM strength, endurance, and repeatability was only observed in the Pilates group. In addition, the Pilates group showed greater adherence to the intervention.

Conclusion

Pilates exercise program with PFM contraction is not able to change the PFM strength assessed by manometer in pregnant women, but it improved adherence to the intervention.     

Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial

Objective: To evaluate the effects of an increase in the intensity of rehabilitation on the functional outcome of patients with traumatic brain injury (TBI).

Design and methods: Sixty-eight patients (age 12-65 years) with moderate-to-severe TBI were included. They were randomized into high (4-hour/day) or control (2-hour/day) intensity rehabilitation programmes at an average of 20 days after the injury. The programmes ended when the patients achieved independence in daily activities or when 6 months had passed.

Outcome and results: No significant differences were found in the Functional Independence Measure (FIM) (primary outcome) and Neurobehavioural Cognitive Status Examination (NCSE) total scores between the two groups. There were significantly more patients in the high intensity group than in the control group who achieved a maximum FIM total score at the third month (47% vs. 19%, p = 0.015) and a maximum Glasgow Outcome Scale (GOS) score at the second (28% vs. 8%, p = 0.034) and third months (34% vs. 14%, p = 0.044).

Conclusions: Early intensive rehabilitation may improve the functional outcome of patients with TBI in the early months post-injury and hence increase the chance of their returning to work early. Intensive rehabilitation in this study speeded up recovery rather than changed the final outcome.     

Is there a role for drain use in elective laparoscopic cholecystectomy? A controlled randomized trial

Background

Although the issue of drain use in open cholecystectomy has been adequately addressed by prospective randomized trials, there is lack of evidence on the usefulness of drains in elective laparoscopic cholecystectomy, and the surgeons follow their beliefs and bias on this debate. Therefore, a controlled randomized trial was designed to assess the value of drains in elective laparoscopic cholecystectomy.

Methods

During a 5-year period (January 2002 to December 2006), 284 patients were randomized to have a drain placed (group A), whereas 281 patients were randomized not to have a drain (group B) placed in the subhepatic space. End points of this trial were to detect any differences in morbidity, postoperative pain, and hospital stay between the 2 groups.

Results

There was no mortality in either group and no statistically significant difference in morbidity or hospital stay between the 2 groups. However, postoperative pain was significantly increased in patients who had a drain placed; median visual analog scale (VAS) score was 5 (range 1 to 8) versus 3 (range 1 to 8), in the non-drained group (P < .0001). Interestingly, in 2 of 3 patients in whom a drain was placed against randomization because of bile leak suspicion, a bile leak occurred.

Conclusions

The routine use of a drain in elective laparoscopic cholecystectomy has nothing to offer; in contrast, it is associated with increased pain. It would be reasonable, however, to leave a drain if there is a worry about an unsolved or potential bile leak, bearing in mind that drain placement, although sometimes providing a false sense of security, does not guarantee either prevention or treatment of postoperative bile collections, bleeding, or bile peritonitis.     

Do holding exercises or antimuscarinics increase maximum voided volume in monosymptomatic nocturnal enuresis? A randomized controlled trial in children

PURPOSE: We assessed prospectively the efficacy of holding exercises and/or antimuscarinics (oxybutynin chloride and placebo) for increasing maximum voided volume in prepubertal children with monosymptomatic nocturnal enuresis. MATERIALS AND METHODS: We randomly allocated 149 children to 5 groups, namely holding exercises with placebo (group A), holding exercises with oxybutynin (group B), placebo alone (group C), oxybutynin alone (group D) and alarm treatment (controls, group E). Maximum voided volume was the greatest voided volume from a 48-hour bladder diary, and holding exercise volume was the greatest volume produced with postponement of voiding after a fluid load, once daily for 4 days. Study medication, holding exercise procedures and alarm treatment were administered for 12 weeks. RESULTS: Holding exercises combined with placebo or oxybutynin significantly increased holding exercise volume and maximum voided volume, by 25% (p <0.001) and 21% (p <0.01), respectively, in group A, and by 43% (p <0.001) and 41% (p <0.001), respectively, in group B. Medication without holding exercises (groups C and D) did not increase holding exercise volume or maximum voided volume, and in these groups oxybutynin was not significantly superior to placebo. A borderline increase in holding exercise volume did not affect maximum voided volume in group E. Monosymptomatic nocturnal enuresis response was significantly lower with all 4 holding exercise volume modulating treatments (7%) compared to alarm therapy (73%). CONCLUSIONS: In the treatment of children with monosymptomatic nocturnal enuresis maximum voided volume can be increased significantly through holding exercises, but not with oxybutynin chloride alone. Compared to controls, increasing maximum voided volume had a minimal effect on monosymptomatic nocturnal enuresis.     

Aerosolized lancovutide in adolescents (≥12 years) and adults with cystic fibrosis – a randomized trial

BackgroundLancovutide activates a chloride channel (TMEM-16A) other than the cystic fibrosis (CF) transmembrane conductance regulator protein and could benefit CF patients.MethodsIn this randomized, multi-center, double-blind, placebo-controlled, parallel-group trial 161 patients ≥12 years with a confirmed diagnosis of CF were randomized to either placebo (saline) or active drug in 3 different dosing schemes of 2.5mg inhaled lancovutide (once daily, every other day or twice a week) for eight weeks. The primary endpoint was the change in the forced expiratory volume in 1 second (FEV1) percent predicted. Secondary endpoints included further lung function parameters (FEV1 (absolute), functional vital capacity percent predicted, forced expiratory flow percent predicted, pulse oximetry), quality of life assessment, pulmonary exacerbations, hospitalization due to pulmonary exacerbations, time to first pulmonary exacerbation, duration of anti-inflammatory, mucolytic or antibiotic treatment, and safety.ResultsThere was no significant difference in the change in FEV1 percent predicted, quality of life, other lung function parameters, pulmonary exacerbations or requirement of additional treatment between groups. Overall, the inhalation of lancovutide was safe although a higher rate of adverse events, especially related to the respiratory system, occurred as compared to placebo.ConclusionsLancovutide did not improve FEV1 percent predicted when compared to placebo (NCT00671736).     

Effects of milk salt supplementation on bone mineral gain in pubertal Chinese adolescents: A 2-year randomized,double-blind,controlled, dose–response trial

Background/objectiveAdequate calcium intakes may enhance bone mineral accumulation during childhood. Little is known about the optimal calcium intake in Chinese adolescents. We examined the effects of three levels of calcium intake on bone mineral accretion in adolescents.MethodsThis was a 2-year randomized, double-blind, controlled trial. The subjects were randomly assigned to receive 40 g of milk powder containing 300 mg of calcium and 200 IU of vitamin D (Low-Ca group), or same milk powder additionally fortified with 300 mg of calcium (Mid-Ca group) or 600 mg of calcium (High-Ca group) for 2 years. The subjects' bone mineral density (BMD) and bone mineral content (BMC) at the total body, lumbar spine and left hip were determined by dual-energy X-ray absorptiometry at baseline and after the second year of treatment. Of the 111 girls and 109 boys (aged 12–14 years) enrolled, 91 girls and 91 boys completed the trial.ResultsThe girls in the High-Ca group (1,110 mg/d) had 2.3%, 2.7% and 2.6% greater BMD accretion at the total hip, femoral neck and shaft (P < 0.05) but not at total body less head and spine than those in the Low-Ca group (655 mg/d). A significant effect of higher calcium intake was also observed for percentage change of size-adjusted BMC at femur neck (P = 0.047). Bonferroni tests indicated no significant differences in the percentage changes in BMD, BMC or size-adjusted BMC between the Mid- and Low-Ca groups and between the High- and Mid-Ca groups. Extra calcium had no observable additional effect in the boys (P > 0.05).ConclusionAn intake of 1000 mg/d or more might be helpful in maximizing bone mineral accretion in the hip for girls. But further large studies are required to identify its long-term effects and the optimal calcium intake for boys.