scholarly journals Side Effects of Intravenous Patient-Controlled Analgesia with Remifentanil Compared with Intermittent Epidural Bolus for Labour Analgesia – A Randomized Controlled Trial

PRILOZI ◽  
2019 ◽  
Vol 40 (3) ◽  
pp. 99-108
Author(s):  
Dafina Karadjova ◽  
Mirjana Shosholcheva ◽  
Еmilija Ivanov ◽  
Аtanas Sivevski ◽  
Ivo Kjaev ◽  
...  
Keyword(s):  
Side Effects ◽  
Epidural Analgesia ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Patient Controlled Analgesia ◽  
Obstetric Anaesthesia ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Remifentanil Group

Abstract Introduction: Epidural analgesia is considered a gold standard in obstetric anaesthesia and analgesia. However, in situation when it is contraindicated, unwanted by the patient or simply unavailable, remifentanil can be an excellent alternative. The goal of our study is to analyse the side effects of intravenous patient-controlled analgesia (IV PCA) with remifentanil compared with epidural analgesia during delivery. Material and methods: This study included 155 pregnant women in term for birth, divided into 2 groups: a remifentanil group (RG), and an epidural group (EG). Patients in the RG received intravenous PCA with remifentanil, while patients in the ЕG received epidural analgesia with programmed intermittent bolus dosing. Our primary outcome was maternal safety; the secondary outcome was neonatal safety. Results: The results present a significantly lower SaO2 value of the parturients in the RG (96.95 ± 1.4 vs 98.22 ± 0.6), and a significantly higher respiratory rate per minute in the EG at all time points after the onset of analgesia (20.85 ± 1.4 vs 18.67 ± 0.9). There was more frequent sedation, nausea and vomiting in the RG, while in the EG there was a more elevated temperature, itching and irregularities in the CTG record. Regarding the newborn, there was no significant difference between the two groups in the Apgar scores, pH, pCO2, pO2, and bicarbonate, while there was a significantly lower value of the base excess in the RG group. Conclusion: PCA with remifentanil is safe for the mother, foetus and the newborn, with minimal side effects. Continuous respiratory monitoring, oxygen supply and following of all consensus recommendations are mandatory.

scholarly journals CCT: continuous care trial - a randomized controlled trial of the provision of continuous care during labor by maternity care assistants in the Netherlands

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Adrie Lettink ◽  
Karina Chaibekava ◽  
Luc Smits ◽  
Josje Langenveld ◽  
Rafli van de Laar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Epidural Analgesia ◽  
Maternity Care ◽  
Primary Outcome ◽  
Impact Analysis ◽  
Budget Impact ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Continuous Care

Abstract Background In 2009, the Steering Committee for Pregnancy and Childbirth in the Netherlands recommended the implementation of continuous care during labor in order to improve perinatal outcomes. However, in current care, routine maternity caregivers are unable to provide this type of care, resulting in an implementation rate of less than 30%. Maternity care assistants (MCAs), who already play a nursing role in low risk births in the second stage of labor and in homecare during the postnatal period, might be able to fill this gap. In this study, we aim to explore the (cost) effectiveness of adding MCAs to routine first- and second-line maternity care, with the idea that these MCAs would offer continuous care to women during labor. Methods A randomized controlled trial (RCT) will be performed comparing continuous care (CC) with care-as-usual (CAU). All women intending to have a vaginal birth, who have an understanding of the Dutch language and are > 18 years of age, will be eligible for inclusion. The intervention consists of the provision of continuous care by a trained MCA from the moment the supervising maternity caregiver establishes that labor has started. The primary outcome will be use of epidural analgesia (EA). Our secondary outcomes will be referrals from primary care to secondary care, caesarean delivery, instrumental delivery, adverse outcomes associated with epidural (fever, augmentation of labor, prolonged labor, postpartum hemorrhage, duration of postpartum stay in hospital for mother and/or newborn), women’s satisfaction with the birth experience, cost-effectiveness, and a budget impact analysis. Cost effectiveness will be calculated by QALY per prevented EA based on the utility index from the EQ-5D and the usage of healthcare services. A standardized sensitivity analysis will be carried out to quantify the outcome in addition to a budget impact analysis. In order to show a reduction from 25 to 17% in the primary outcome (alpha 0.05 and bèta 0.20), taking into account an extra 10% sample size for multi-level analysis and an attrition rate of 10%, 2 × 496 women will be needed (n = 992). Discussion We expect that adding MCAs to the routine maternity care team will result in a decrease in the use of epidural analgesia and subsequent costs without a reduction in patient satisfaction. It will therefore be a cost-effective intervention. Trial registration Trial Registration: Netherlands Trial Register, NL8065. Registered 3 October 2019 - Retrospectively registered.

scholarly journals Efficacy of a U-Shaped Automatic Electric Toothbrush in Dental Plaque Removal: A Cross-Over Randomized Controlled Trial

2020 ◽  
Vol 17 (13) ◽  
pp. 4649
Author(s):  
Michele Nieri ◽  
Veronica Giuntini ◽  
Umberto Pagliaro ◽  
Monica Giani ◽  
Lorenzo Franchi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Dental Plaque ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Outcome Variable ◽  
Plaque Score ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Electric Toothbrush

Background: The aim of this single-use, four-treatment, four-period (visit), cross-over, mono-centered, examiner-blind, cross-over randomized controlled trial (RCT) was to evaluate the efficacy in dental plaque removal of a U-shaped automatic electric toothbrush (U) compared to a conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N). Methods: Eligible participants were volunteer students. Primary outcome measure was the reduction in full-mouth plaque score (FMPS) after brushing. The secondary outcome variable was a visual analogic scale (VAS) on subjective clean mouth sensation. Mixed models were performed for difference in FMPS and VAS. Results: Twenty-two participants were randomized to the treatments in the four periods of the study. The differences between treatments in FMPS reduction after brushing were statistically significant (p < 0.0001). The differences were statistically significant between the U and P groups (difference −48; 95% CI from −54 to −41) favoring the P group, and between the U and H groups (difference −45; 95% CI from −52 to −39) favoring the H group. On the contrary, the difference between the U and N groups was not significant (difference 5; 95% CI from −2 to 12) favoring the U group. The differences between treatments in clean mouth VAS was statistically significant (p < 0.0001) favoring the P and H groups. Conclusions: The U-shaped automatic electric toothbrush tested in this study proved to be not effective in removing dental plaque.

scholarly journals Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Feng Bin Lin ◽  
◽  
Shi Da Chen ◽  
Yun He Song ◽  
Wei Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intraocular Pressure ◽  
High Myopia ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Rank Test ◽  
Inner Plexiform Layer ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Currently, whether and when intraocular pressure (IOP)-lowering medication should be used in glaucoma suspects with high myopia (GSHM) remains unknown. Glaucoma suspects are visual field (VF) defects that cannot be explained by myopic macular changes or other retinal and neurologic conditions. Glaucoma progression is defined by VF deterioration. Here we describe the rationale, design, and methodology of a randomized controlled trial (RCT) designed to evaluate the effects of medically lowering IOP in GSHM (GSHM study). Methods The GSHM study is an open-label, single-center, RCT for GSHM. Overall, 264 newly diagnosed participants, aged 35 to 65 years, will be recruited at the Zhongshan Ophthalmic Center, Sun Yat-sen University, between 2020 and 2021. Participants will be randomly divided into two arms at a 1:1 ratio. Participants in the intervention arm will receive IOP-lowering medication, while participants in the control arm will be followed up without treatment for 36 months or until they reach the end point. Only one eye per participant will be eligible for the study. If both eyes are eligible, the eye with the worse VF will be recruited. The primary outcome is the incidence of glaucoma suspect progression by VF testing over 36 months. The secondary outcomes include the incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer, and retinal ganglion cell-inner plexiform layer loss, progression of myopic maculopathy, visual function loss, and change in the quality of life. Statistical analyses will include baseline characteristics comparison between the intervention and control groups using a two-sample t-test and Wilcoxon rank sum test; generalized linear models with Poisson regression for the primary outcome; Kaplan-Meier curve and log-rank test for the incidence of the secondary outcome; and longitudinal analyses to assess trends in outcomes across time. Discussion To the best of our knowledge, the GSHM study is the first RCT to investigate the impact of medically lowering IOP in GSHM. The results will have implications for the clinical management of GSHM. Trial registration ClinicalTrials.gov NCT04296916. Registered on 4 March 2020

scholarly journals Patient-Controlled Epidural Analgesia in Labour — is a Continuous Infusion of Benefit?

1992 ◽  
Vol 20 (1) ◽  
pp. 15-20 ◽  
Author(s):  
M. J. Paech
Keyword(s):  
Side Effects ◽  
Epidural Analgesia ◽  
Patient Controlled Analgesia ◽  
Self Administration ◽  
High Quality ◽  
Active Labour ◽  
Background Infusion ◽  
Significant Difference ◽  
Continuous Background ◽  
Single Blind

A randomised, single-blind study was conducted among 52 gravida in active labour, to investigate two variants of patient-controlled epidural analgesia — bolus only versus bolus plus infusion. Patient-controlled analgesia variables, using an epidural solution of 0.125% bupivacaine plus fentanyl 3 mcg per ml, were a 4 ml incremental bolus with 15 minute lockout, plus or minus a 4 ml per hour infusion. Up to three additional staff-administered supplements of 0.5% bupivacaine 4 ml (20 mg) were allowed. There was no significant difference between groups with respect to pain relief, supplementary boluses required, satisfaction, side-effects or details of patient-controlled epidural analgesia, with the exception of greater fentanyl usage in the bolus plus infusion group (P < 0.003). Both groups had high quality analgesia, low rates of bupivacaine usage and were highly satisfied. However, under the conditions of the study, the addition of a continuous background infusion to self-administration conferred no benefit.

scholarly journals Randomized Controlled Trial of Probiotic PS128 in Children with Tourette Syndrome

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 3698
Author(s):  
Chang-Chun Wu ◽  
Lee-Chin Wong ◽  
Chia-Jui Hsu ◽  
Chianne-Wen Yang ◽  
Ying-Chieh Tsai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Tourette Syndrome ◽  
Performance Test ◽  
Controlled Trial ◽  
Continuous Performance Test ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Social Environmental

Tourette syndrome results from a complex interaction between social–environmental factors, multiple genetic abnormalities, and neurotransmitter disturbances. This study is a double-blinded, randomized controlled trial using probiotics Lactobacillus plantarum PS128 as an intervention to examine if probiotics improve symptoms of children with Tourette syndrome. This study enrolled children aged 5 to 18 years old who fulfilled DSM-V diagnostic criteria for Tourette syndrome. Patients were assessed before initiating the trial, at one month, and at two months after randomization. The primary outcome was evaluated by Yale Global Tic Severity Scale (YGTSS), and the secondary outcome studied the possible comorbidities in these children. The results revealed no significant difference in improvement in YGTSS between the control group and the PS128 group. As for secondary endpoints, an analysis of Conners’ Continuous Performance Test (CPT) showed improvement in commission and detectability in the PS128 group. In conclusion, although probiotics may not have tic-reducing effects in children with Tourette syndrome, it may have benefits on comorbidities such as attention deficit and hyperactivity disorder (ADHD). Further studies are needed to clarify the effects of probiotics on the comorbidities of Tourette syndrome children.

scholarly journals Effects of thiamine on vasopressor requirements in patients with septic shock: a prospective randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Suttasinee Petsakul ◽  
Sunthiti Morakul ◽  
Viratch Tangsujaritvijit ◽  
Parinya Kunawut ◽  
Pongsasit Singhatas ◽  
...  
Keyword(s):  
Septic Shock ◽  
Sample Size ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Double Blind ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference ◽  
Dependency Index

Abstract Background Thiamine, an essential vitamin for aerobic metabolism and glutathione cycling, may decrease the effects of critical illnesses. The objective of this study was to determine whether intravenous thiamine administration can reduce vasopressor requirements in patients with septic shock. Methods This study was a prospective randomized double-blind placebo-controlled trial. We included adult patients with septic shock who required a vasopressor within 1–24 h after admission between March 2018 and January 2019 at a tertiary hospital in Thailand. Patients were divided into two groups: those who received 200 mg thiamine or those receiving a placebo every 12 h for 7 days or until hospital discharge. The primary outcome was the number of vasopressor-free days over 7 days. The pre-defined sample size was 31 patients per group, and the study was terminated early due to difficult recruitment. Results Sixty-two patients were screened and 50 patients were finally enrolled in the study, 25 in each group. There was no difference in the primary outcome of vasopressor-free days within the 7-day period between the thiamine and placebo groups (mean: 4.9 days (1.9) vs. 4.0 days (2.7), p = 0.197, mean difference − 0.9, 95% CI (− 2.9 to 0.5)). However, the reductions in lactate (p = 0.024) and in the vasopressor dependency index (p = 0.02) at 24 h were greater among subjects who received thiamine repletion vs. the placebo. No statistically significant difference was observed in SOFA scores within 7 days, vasopressor dependency index within 4 days and 7 days, or 28-day mortality. Conclusions Thiamine was not associated to a significant reduction in vasopressor-free days over 7-days in comparison to placebo in patients with septic shock. Administration of thiamine could be associated with a reduction in vasopressor dependency index and lactate level within 24 h. The study is limited by early stopping and low sample size. Trial registration TCTR, TCTR20180310001. Registered 8 March 2018, http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=3330.

A Randomized Controlled Trial of Patient Controlled Analgesia Versus Continuous Infusion of Morphine during Vaso-Occlusive Crisis in Sickle Cell Disease.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3805-3805
Author(s):  
Eduard J. Beers van ◽  
Charlotte F.J. Tuijn van ◽  
Pythia T. Nieuwkerk ◽  
Philip W. Friederich ◽  
Marcel M. Levi ◽  
...  
Keyword(s):  
Side Effects ◽  
Pain Intensity ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Morphine Consumption ◽  
Cell Disease ◽  
Patient Controlled Analgesia ◽  
Morphine Dose ◽  
Randomized Controlled ◽  
The Mean

Abstract Intravenous morphine is the treatment of choice for severe pain during vaso-occlusive crisis in sickle cell disease (SCD). However, side-effects of morphine may hamper effective treatment and high plasma levels of morphine are associated with severe complications such as acute chest syndrome. Furthermore, adequate dosing remains a problem since no objective measurement of pain severity exists and analgesia should be titrated upon the patient’s reported pain. Patient-controlled analgesia (PCA) may therefore be an interesting alternative since patients can titrate the level of analgesia themselves. Although PCA is currently used for the treatment of vaso-occlusive crises in SCD, no randomized controlled trials have been performed in admitted patients with a vaso-occlusive crisis so far. In the present study, we conducted a randomized controlled trial to compare the administration of morphine with PCA versus CI in sickle cell patients with vaso-occlusive crises. Patients were randomized between PCA and CI of morphine within 24 hours after hospital admission. Endpoints of the study were: the mean and cumulative morphine dose, pain intensity, incidence of side-effects (nausea, constipation, pruritus and drowsiness) and quality of life (QoL). Pain intensity was measured daily using a ten-point-scale verbal pain score. Reduction of pain intensity was measured by subtracting a pain score on a ten point visual analogue scale (VAS) before randomization from the same measurement two days after randomization. Side-effects were measured four times per day on a 11-point numerical rating scale. QoL was measured using the 36-item Short Form Healthy Survey (SF36). Twenty five consecutive episodes of vaso-occlusive crisis in 19 patients with SCD were included in the study. No difference in the mean daily pain scores were found between the two groups (4.9 versus 5.3). However, patients in the PCA-group demonstrated to have a strongly reduced mean and cumulative morphine consumption as compared to the patients in the CI-group (0.5 mg/h versus 2.4 mg/h (P<0.001) and 33 mg versus 260 mg (P=0.018) respectively). The lower mean and cumulative morphine consumption in the PCA-group led to significant less nausea and constipation during treatment as compared to the CI-group (area under the curve respectively 11 versus 18 (P= 0.045) and 30 versus 45 (P= 0.021)). Furthermore, a non-significant reduction in the duration of hospital admission of 3 days was observed in the PCA-group. Patient controlled analgesia results in adequate pain relief at a much lower morphine consumption and should considered to be first choice in morphine administration to sickle cell patients admitted with vaso-occlusive crisis. Figure. Mean morphine dose per patient Figure. Mean morphine dose per patient

Patient-Controlled Analgesia (PCA) with Remifentanil Versus Intermittent Epidural Boluses for Labor Analgesia

2017 ◽  
Vol 71 (2) ◽  
pp. 99-104
Author(s):  
Dafina Karadjova ◽  
Mirjana Shosholcheva ◽  
Atanas Sivevski ◽  
Emilija Ivanov ◽  
Ivo Kjaev ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Epidural Analgesia ◽  
Labor Analgesia ◽  
Nausea And Vomiting ◽  
Pain Patient ◽  
Patient Controlled Analgesia ◽  
Pain Scores ◽  
Significant Difference ◽  
Patient Pain ◽  
Remifentanil Group

Abstract Introduction. Remifentanil is becoming more and more popular for labor analgesia as an alternative for neuro-axial anesthesia. In this study we compared the severity of pain, patient satisfaction and side effects between two different types of labor analgesia. Methods. Eightyprimiparous patients ASA I or II, atterm pregnancy, were included in the study and divided in two groups. The first group (35 patients) received intravenous remifentanil on patient control pump in bolus doses. The second group (45 patients) received intermittent epidural boluses with highly diluted local anesthetic and opioid (Bupivacain and Fentanil). We analyzed oxygen saturation (SpO2), respiration rate, heart rate, blood pressure, sedation, nausea and vomiting as well as patient pain scores and satisfaction scores through 2 different VAS. Results. Mean SpO2 was significantly lower in the PCA remifentanil group 96.2%±1.6 versus 98.2±1.2 in the epidural group. Respiratory depression (RR<9 or SpO2 <90%) was not found in both groups. Sedation scores were significantly higher in the PCA remifentanil group, P<0.05. Incidence of nausea and vomiting was similar between the two groups, without significant difference. PCA remifentanil was inferior to epidural analgesia with respect to pain scores at all time points, but without significant difference in patient satisfaction between the two groups. Conclusion. Intravenous patient-controlled analgesia with remifentanil provides satisfactory level of labor analgesia, with lower SpO2 and more sedation. It could be an excellent alternative to epidural analgesia but continuous monitoring and oxygen supply is mandatory.

scholarly journals Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

2018 ◽  
Vol 213 (1) ◽  
pp. 404-411 ◽  
Author(s):  
Ulrika Karlsson Stigsdotter ◽  
Sus Sola Corazon ◽  
Ulrik Sidenius ◽  
Patrik Karlsson Nyed ◽  
Helmer Bøving Larsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Significant Difference ◽  
Increasing Demand ◽  
Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

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