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To improve our understanding of adherence to discharge medications in the ED and within research trials, we sought to quantify medication adherence and identify predictors thereof in children with acute gastroenteritis (AGE). We conducted a secondary analysis of a randomized trial of twice daily probiotic for 5 days. The population included previously healthy children aged 3-47 months with AGE. The primary outcome was patient-reported adherence to the treatment regimen, defined a priori as having received >70% of the prescribed doses. Secondary outcomes included predictors of treatment adherence and concordance between patient-reported adherence and the returned medication sachet counts. After excluding participants with missing data on adherence, 760 participants were included in this analysis: 383 in the probiotic arm (50.4%); and 377 in the placebo arm (49.6%). Self-reported adherence was similar in both groups (77.0% in probiotic versus 80.3% in placebo). There was good agreement between self-reported adherence and sachet counts (87% within limits of agreement (-2.9 to 3.5 sachets) on the Bland-Altman plots). In the multivariable regression model, covariates associated with adherence were greater number of days of diarrhea post-emergency department visit, and the study site; covariates negatively associated with adherence were age 12-23 months, severe dehydration and greater total number of vomiting and diarrhea episodes after enrolment. Longer duration of diarrhea and study site were associated with higher probiotic adherence. Age 12-23 months, severe dehydration and greater number of vomiting and diarrhea episodes post enrolment negatively predicted treatment adherence.

The transversus thoracis muscle plane (TTMP) block provides effective analgesia in cardiac surgery patients. The aim of this study was to assess whether bilateral TTMP blocks can reduce the incidence of postoperative cognitive dysfunction (POCD) in patients undergoing cardiac valve replacement. A group of 103 patients were randomly divided into the TTM group (n = 52) and the PLA (placebo) group (n = 51). The primary endpoint was the incidence of POCD at 1 week after surgery. Secondary outcome measures included a reduction of intraoperative mean arterial pressure (MAP) >20% from baseline, intraoperative and postoperative sufentanil consumption, length of stay in the ICU, incidence of postoperative nausea and vomiting (PONV), time to first faeces, postoperative pain at 24 h after surgery, time to extubation and the length of hospital stay. Interleukin (IL)‐6, TNF‐α, S‐100β, insulin, glucose and insulin resistance were measured at before induction of anaesthesia, 1, 3and 7 days after surgery. The MoCA scores were significantly lower and the incidence of POCD decreased significantly in TTM group compared with PLA group at 7 days after surgery. Perioperative sufentanil consumption, the incidence of PONV and intraoperative MAP reduction >20% from baseline, length of stay in the ICU, postoperative pain at 24 h after surgery, time to extubation and the length of hospital stay were significantly decreased in the TTM group. Postoperatively, IL‐6, TNF‐α, S‐100β, HOMA‐IR, insulin, glucose levels increased and the TTM group had a lower degree than the PLA group at 1, 3 and 7 days after surgery. In summary, bilateral TTMP blocks could improve postoperative cognitive function in patients undergoing cardiac valve replacement.

Purpose Emergence from anesthesia is a critical period and cough can result in adverse effects. Propofol inhibits airway reflexes and when infused it reduces cough more than inhalation anesthesia does. We evaluated the effect of a propofol bolus given at emergence on the incidence of coughing following a desflurane-based anesthesia. Methods One hundred and fifty-four patients scheduled for elective surgery were prospectively randomized to propofol (0.5 mg·kg −1 ) or normal saline (NS) administered at the end of the surgery at 1 minimum alveolar concentration (MAC) of desflurane. A “no touch” emergence technique was used until extubation. The primary outcome was the incidence of cough at the discontinuation of desflurane (T0) and reaching a MAC adjusted for age (MAC age ) of 0.15. Secondary outcomes included incidence and severity of cough until five minutes postextubation (T0–T5), time to extubation, nausea and vomiting, sedation, hemodynamic variations, postoperative hypoventilation, hypoxemia, and sore throat. Results We could not draw inferences on the incidence of cough between T0 and MAC age of 0.15 because only 27/68 (40%) patients in the NS group and 13/73 (18%) patients in the propofol group regained consciousness before reaching a MAC age of 0.15. There were no significant differences between the groups in coughing incidence and severity between T0 and T5 (NS group, 57/68 [84%] vs propofol group, 70/73 [96%] ). The mean time to extubation in the propofol group was prolonged by 3 min 27 sec (95% confidence interval, 1 min 7 sec to 4 min 47 sec; P < 0.001) and more vasopressors were used at emergence ( P = 0.02). The incidence of respiratory complications, nausea and vomiting, agitation, and sedation were not different between groups. Conclusion In the present trial, a propofol bolus administered at emergence did not reduce the incidence of cough occurring between T0 and T5 following a desflurane-based general anesthesia compared with placebo. Trial registration ClinicalTrials.gov (NCT02932397); registered 13 October 2016.

Background Postoperative delirium (POD) is a serious complication following anaesthesia and surgery and significantly influences postoperative outcome especially in the elderly population. Intraoperative music and positive suggestions influence postoperative outcomes by attenuating analgesic demand and increasing patient satisfaction. Aims Here, we examined the effect of intraoperative music and positive suggestions on the development of POD in aged patients undergoing transcatheter aortic valve replacement (TAVR) procedure under general anaesthesia. Methods For this randomized placebo-controlled study, eligible patients without cognitive deficit, indicated by a MMSE < 10 points, were anesthetized using remifentanil and sevoflurane. Anaesthetic depth was guide with bispectral index. An audiotape with positive suggestions was applied from a MP3 player via headphones. POD, pain and PONV was assessed. CAM-ICU and Nu-DESC were done twice daily for the first 5 days. Results Of 140 patients 118 patients could be analysed (57 male, 80.6 ± 5.1 years). POD was diagnosed in 16 patients (12.7%). POD was significantly more often observed in male (12, 21.1%) than in female (4, 6.6%, p = 0.02) and in patients with a low MMSE (23.6 ± 4.5 vs. 26.8 ± 2.8, p = 0.001). Anaesthetic depth did not influence the incidence of POD. Intraoperative music and suggestions did not affect the rate of POD, pain, analgesic requirement or PONV. Discussion In patients undergoing TAVR male sex and low MMSE scoring are associated with an increase in POD. Conclusions Intraoperative music and positive suggestions do not influence the incidence of POD in this patient group. Study registration DRKS: 00024444, start of registration: 4.02.202, final registration: 17.09.2021

We report information about an unpublished 1970s study (\"8-way\" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published. Double blinded, multi-centred, randomized placebo-controlled study. 14 clinics in the United States. 2308 patients in the first 12 weeks of pregnancy with complaints of nausea or vomiting were enrolled. Each patient was randomized to one of eight arms: placebo, doxylamine/pyridoxine/dicylcomine, doxylamine/pyridoxine, dicylomine/pyridoxine, doxylamine, dicyclomine/pyridoxine, pyridoxine and dicyclomine. Each patient was instructed to take 2 tablets at bedtime and 1 additional tablet in the afternoon or morning if needed, for 7 nights. Reported outcomes included the number of hours of nausea reported by patients, the frequency of vomiting reported by patients and the overall efficacy of medication as judged by physicians. Data from 1599 (69% of those randomized) participants were analyzed. Based on the available summary data of physician evaluation of symptoms and ignoring missing data and data integrity issues, the proportion of participants who were \"evaluated moderate or excellent\" was greater in each of the seven active treatment groups when compared with placebo (57%): doxylamine/pyridoxine/dicylcomine (14% absolute difference versus placebo; 95% CI: 4 to 24), doxylamine/pyridoxine (21; 95% CI 11 to 30), dicylomine/pyridoxine (21; 95% CI 11 to 30), doxylamine (20; 95% CI 10 to 29), dicyclomine/pyridoxine (4; 95% CI -6 to 14), pyridoxine (9; 95% CI -1 to 19) and dicyclomine (4; 95% CI -6 to 14). Based on incomplete information, the most common adverse events were apparently drowsiness and fatigue. There is a high risk of bias in these previously unpublished results given the high attrition rate in a 7 day trial, the lack of prespecified outcomes or analyses, and the exclusion of some data because of questionable data integrity. The available information about this \"8-way Bendectin\" trial indicates it should not be used to support the efficacy of doxylamine, pyridoxine or dicyclomine for the treatment of nausea and vomiting during pregnancy because of a high risk of bias. Not registered.

Introduction In this study we aimed to compare the efficacy of peritonsillar injection of bupivacaine and intravenous acetaminophen on post-tonsillectomy pain in children. Materials and methods In this randomized double-blind clinical trial study 60 children with ASA = I–II aged 5–12 years undergoing tonsillectomy were involved. The first group received bupivacaine at a dose of 0.1 mg/kg that was injected into the bed and the anterior crease of each tonsil. The second group was given intravenous acetaminophen at a dose of 12.5 mg/kg. The patient’s pain score at 10, 30, 60 min after his/her admission to recovery room and 120, 240 and 360 min after the surgery was recorded using CHEOPS. Patient’s sedation score, nausea or vomiting, the time of the first request for analgesia and the time of starting oral feeding were recorded and analyzed too. Results There was no significant differences in mean age ( p value = 0.44), gender ( p value = 0.79), weight ( p value = 0.36), height ( p value = 0.17), anesthesia duration ( p .value = 0.85) and surgery duration ( p .value = 0.73) between two groups. Postoperative pain was significantly less in the bupivacaine group at 240 and 360 min after the surgery. The mean sedation score was higher in the bupivacaine group but not significantly. There was no significant difference between groups regarding the nausea and vomiting, the first analgesics request time and the start time of oral feeding. Conclusion According to the results of the present study, since administration of peritonsillar bupivacaine compared to acetaminophen had a better effect on managing postoperative pain and improving sedation and also since no complications were reported; therefore, peritonsillar infiltration with bupivacaine is suggested for pediatric tonsillectomy.

Background Postoperative pain after TKA is a major concern to patients. The best technique to control pain is still controversial. Intrathecal morphine or periarticular multimodal drug injection are both commonly used and both appear to provide better pain control than placebo, but it is unclear whether one or the other provides better pain control. Questions/purposes We asked whether intrathecal morphine or periarticular multimodal drug injection provides better pain control with fewer adverse events. Methods In a prospective, double-blind, randomized controlled trial we randomized 57 patients with osteoarthritic knees who underwent TKAs into two groups. Group M (n = 28) received 0.2 mg intrathecal morphine while Group I (n = 29) received periarticular multimodal drug injection. Postoperative pain was managed with patient-controlled analgesia using ketorolac. The outcomes were pain levels, the amount of analgesic drug used, and drug-related side effects. Patients and evaluators were blinded. All patients were followed up to 3 months. Results We found no difference in postoperative pain level, analgesia drug consumption, blood loss in drain, and knee function. More patients in Group M required antiemetic (19 [69%] versus 10 [34%]) and antipruritic drugs (10 [36%] versus three [10%]) than patients in Group I. Conclusions The two techniques provide no different pain control capacity. The periarticular multimodal drug injection was associated with lower rates of vomiting and pruritus. Level of Evidence Level I, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

GDF15, a hormone acting on the brainstem, has been implicated in the nausea and vomiting of pregnancy, including its most severe form, hyperemesis gravidarum (HG), but a full mechanistic understanding is lacking 1 – 4 . Here we report that fetal production of GDF15 and maternal sensitivity to it both contribute substantially to the risk of HG. We confirmed that higher GDF15 levels in maternal blood are associated with vomiting in pregnancy and HG. Using mass spectrometry to detect a naturally labelled GDF15 variant, we demonstrate that the vast majority of GDF15 in the maternal plasma is derived from the feto-placental unit. By studying carriers of rare and common genetic variants, we found that low levels of GDF15 in the non-pregnant state increase the risk of developing HG. Conversely, women with β-thalassaemia, a condition in which GDF15 levels are chronically high 5 , report very low levels of nausea and vomiting of pregnancy. In mice, the acute food intake response to a bolus of GDF15 is influenced bi-directionally by prior levels of circulating GDF15 in a manner suggesting that this system is susceptible to desensitization. Our findings support a putative causal role for fetally derived GDF15 in the nausea and vomiting of human pregnancy, with maternal sensitivity, at least partly determined by prepregnancy exposure to the hormone, being a major influence on its severity. They also suggest mechanism-based approaches to the treatment and prevention of HG. Elevated circulating levels of GDF15 in pregnant women are associated with severe nausea and vomiting, and sensitivity to such symptoms during pregnancy is partly determined by prepregnancy levels of this hormone.

Background. Aprepitant is a P/neurokinin-1 receptor antagonist approved for the prevention of CINV in moderate emetic risk chemotherapy. We explored its effectiveness in patients with leukemia receiving cytarabine-based chemotherapy. Methods. Patients were randomized to ondansetron (OND) 8 mg IV 30 minutes before cytarabine followed by 24 mg IV continuous infusion daily until 6–12 hours after the last dose of chemotherapy alone or with aprepitant (APREP) oral 125 mg 6–12 hrs before chemotherapy and 80 mg daily until 1 day after the last dose of chemotherapy. Results. Forty-nine patients were enrolled in each arm; 42 in OND and 41 in OND + APREP arm were evaluable for efficacy. The ORR with OND + APREP was 80% compared to 67% with OND alone (P=0.11). On days 6 and 7, higher proportion of patients treated with OND + APREP were free from nausea (74%, 74% versus 68%, 67%; P=0.27 and 0.18, resp.). Requirement of rescue medications on days 2 and 3 was fewer in OND + APREP arm 7% and 5% compared to 21% and 16% in the OND arm, respectively (P=0.06 and P=0.07). Conclusions. There was a trend for overall improvement in emesis with ondansetron plus aprepitant. The potential benefit of this approach with specific chemotherapy combinations remains to be determined.

Healthy children from 7 months to 7 years are known to be at risk for developing hypoglycaemia during prolonged fasting, particularly during acute illness with decreased oral intake. Our study aimed to identify additional factors associated with hypoglycaemia in children with acute vomiting and dehydration. Our retrospective single-centre study included 560 healthy children and adolescents (aged 29 days to 17.96 years) without known metabolic disorders admitted to hospital with dehydration due to acute illness with vomiting or poor oral intake. Historical and anthropometric parameters were evaluated as potential factors associated with hypoglycaemia. A total of 171 (30.5%) participants (aged 0.6-10.7, median 3.8 years) experienced hypoglycaemia (≤3.3 mmol/l). Besides known factors such as a higher degree of dehydration (OR 2.505, 95% CI 1.532-4.095) and complete absence of oral intake (OR 2.185, 95% CI 1.331-3.586), additional factors independently associated with hypoglycaemia included diarrhoea (OR 0.178, 95% CI 0.068-0.468) and lower body mass index (BMI) (OR 0.011, 95% CI 0.000-0.605). Children with hypoglycaemia had a significantly lower BMI (median 14.29 vs 15.46 kg/m2, p < 0.001) than children without hypoglycaemia. Only one child with hypoglycaemia was obese. The highest rate of hypoglycaemia (37.5-51.6%) was observed in the 2-7-year age groups, who also had the lowest median BMI values (13.9-14.8). Low BMI and absence of diarrhoea were associated with increased odds of hypoglycaemia. The typical BMI curve for children with physiologically low values at 2-7 years of age may partially explain the high incidence of hypoglycaemia in otherwise healthy children with decreased oral intake at this age.