Dataset Information

Short-term use of remifentanil during endotracheal extubation for prophylactic analgesia in neurosurgical patients after craniotomy (SURE after Craniotomy Study): a study protocol and statistical analysis plan for a randomised controlled trial.

ABSTRACT:

Introduction

Acute pain is common during the endotracheal extubation period, and is related to complications and adverse outcomes. Patients with delayed extubation after craniotomy are vulnerable to pain and complications of extubation. However, pain control during extubation is still inadequate. Remifentanil, a new opioid with rapid onset and short duration of action, provides adequate analgesia during procedures with minimal effect of respiratory depression.

Methods and analysis

The study is a prospective, randomised, double-blinded, controlled parallel-group design. Patients with delayed extubation after intracranial surgery are screened daily. Adult patients ready for extubation are enrolled and assigned randomly to one of the two treatment study groups, labelled as the 'Remi group' or 'Saline group'. Patients in the Remi group receive an intravenous bolus dose of remifentanil 0.5??g/kg over 60?s followed by a continuous infusion 0.05??g/kg/min for 20?min. Patients in the Saline group receive an intravenous infusion of 0.9% sodium chloride at a volume and rate equal to that of remifentanil. Pain intensity is measured by the visual analogue scale (VAS) pain score. Adverse events during drug infusion are documented and reported. Patients will be followed up until hospital discharge, death or 60?days after the trial intervention on a first come, first served basis. Details of the incidence of reintubation and reoperation within 72?h after extubation, length of stay in the intensive care unit and hospital and mortality are collected. The primary end point is the incidence of severe pain (defined as a VAS pain score more than 5?cm) during the periextubation period (defined as the period of time from immediately before extubation to 20?min after extubation).

Ethics and dissemination

The study was approved by the Institutional Review Board (IRB) of the Beijing Tiantan Hospital, Capital Medical University. The study findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

ClinicalTrials (NCT): ChiCTR-PRC-13003879.

SUBMITTER: Wu YX

PROVIDER: S-EPMC4179578 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Publications

Short-term use of remifentanil during endotracheal extubation for prophylactic analgesia in neurosurgical patients after craniotomy (SURE after Craniotomy Study): a study protocol and statistical analysis plan for a randomised controlled trial.

Wu Yuan-Xing YX Chen Han H Zhou Jian-Xin JX

BMJ open 20140929 9

<h4>Introduction</h4>Acute pain is common during the endotracheal extubation period, and is related to complications and adverse outcomes. Patients with delayed extubation after craniotomy are vulnerable to pain and complications of extubation. However, pain control during extubation is still inadequate. Remifentanil, a new opioid with rapid onset and short duration of action, provides adequate analgesia during procedures with minimal effect of respiratory depression.<h4>Methods and analysis</h4 ...[more]

PMID: 25270857

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Project description:IntroductionFollowing extubation from invasive mechanical ventilation, nearly one in seven critically ill adults requires reintubation. Reintubation is independently associated with increased mortality. Postextubation respiratory support (non-invasive ventilation or high-flow nasal cannula applied at the time of extubation) has been reported in small-to-moderate-sized trials to reduce reintubation rates among hypercapnic patients, high-risk patients without hypercapnia and low-risk patients without hypercapnia. It is unknown whether protocolised provision of postextubation respiratory support to every patient undergoing extubation would reduce the overall reintubation rate, compared with usual care.Methods and analysisThe Protocolized Post-Extubation Respiratory Support (PROPER) trial is a pragmatic, cluster cross-over trial being conducted between 1 October 2017 and 31 March 2019 in the medical intensive care unit of Vanderbilt University Medical Center. PROPER compares usual care versus protocolized post-extubation respiratory support (a respiratory therapist-driven protocol that advises the provision of non-invasive ventilation or high-flow nasal cannula based on patient characteristics). For the duration of the trial, the unit is divided into two clusters. One cluster receives protocolised support and the other receives usual care. Each cluster crosses over between treatment group assignments every 3 months. All adults undergoing extubation from invasive mechanical ventilation are enrolled except those who received less than 12 hours of mechanical ventilation, have 'Do Not Intubate' orders, or have been previously reintubated during the hospitalisation. The anticipated enrolment is approximately 630 patients. The primary outcome is reintubation within 96 hours of extubation.Ethics and disseminationThe trial was approved by the Vanderbilt Institutional Review Board. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.Trial registration numberNCT03288311.

Project description:OBJECTIVE:To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN:Multicentre randomised controlled equivalence trial. SETTING:15 hospitals in the Netherlands. PARTICIPANTS:Women with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women. Because of missing values for satisfaction this number was increased to 1400 before any analysis. We used multiple imputation to correct for missing data. INTERVENTION:Before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour. MAIN OUTCOME MEASURES:Primary outcome was satisfaction with pain relief, measured hourly on a visual analogue scale and expressed as area under the curve (AUC), thus providing a time weighted measure of total satisfaction with pain relief. A higher AUC represents higher satisfaction with pain relief. Secondary outcomes were pain intensity scores, mode of delivery, and maternal and neonatal outcomes. Analysis was done by intention to treat. The study was defined as an equivalence study for the primary outcome. RESULTS:1414 women were randomised, of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia. Baseline characteristics were comparable. Pain relief was ultimately used in 65% (447/687) in the remifentanil group and 52% (347/671) in the epidural analgesia group (relative risk 1.32, 95% confidence interval 1.18 to 1.48). Cross over occurred in 7% (45/687) and 8% (51/671) of women, respectively. Of women primarily treated with remifentanil, 13% (53/402) converted to epidural analgesia, while in women primarily treated with epidural analgesia 1% (3/296) converted to remifentanil. The area under the curve for total satisfaction with pain relief was 30.9 in the remifentanil group versus 33.7 in the epidural analgesia group (mean difference -2.8, 95% confidence interval -6.9 to 1.3). For who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was 25.6 in the remifentanil group versus 36.1 in the epidural analgesia group (mean difference -10.4, -13.9 to -7.0). The rate of caesarean section was 15% in both groups. Oxygen saturation was significantly lower (SpO2 <92%) in women who used remifentanil (relative risk 1.5, 1.4 to 1.7). Maternal and neonatal outcomes were comparable between both groups. CONCLUSION:In women in labour, patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief. Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia. TRIAL REGISTRATION:Netherlands Trial Register NTR2551.

Project description:BackgroundPain is often observed in pediatric patients after craniotomy procedures, which could lead to some serious postoperative complications. However, the optimal formula for postoperative analgesia for pediatric neurosurgery has not been well established. This study aimed to explore the optimal options and formulas for postoperative analgesia in pediatric neurosurgery.MethodsThree hundred and twenty patients aged 1 to 12-years old who underwent craniotomy were randomly assigned to receive 4 different regimens of patient-controlled analgesia. The formulas used were as follows: Control group included normal saline 100 ml, with a background infusion of 2 ml/h, bolus 0.5 ml; Fentanyl group was used with a background infusion of 0.1-0.2 μg/k·h, bolus 0.1-0.2 μg/kg; Morphine group was used with a background infusion of 10-20 μg/kg·h, bolus 10-20 μg/kg; while Tramadol group was used with a background infusion of 100-400 μg/kg·h, bolus 100-200 μg/kg. Postoperative pain scores and analgesia-related complication were recorded respectively. Comparative analysis was performed between the four groups.ResultsIn comparison of all groups with each other, lower pain scores were shown at 1 h and 8 h after surgery in Morphine group versus Tramadol, Fentanyl and Control groups (P < 0.05). Both Tramadol and Fentanyl groups showed lower pain scores in comparison to Control group (P < 0.05). Nausea and vomiting were observed more in Tramadol group in comparison to all other groups during the 48 h of PCIA usage after operation (P = 0.020). Much more rescue medicines including ibuprofen and morphine were used in Control group (CI = 0.000-0.019). Changes in consciousness and respiratory depression were not observed in study groups. Moderate-to-severe pain was observed in a total of 56 (17.5%) of the study population. Multiple regression analysis for identifying risk factors for moderate-to-severe pain revealed that, younger children (OR = 1.161, 1.027-1.312, P = 0.017), occipital craniotomy (OR = 0.374, 0.155-0.905, P = 0.029), and morphine treatment (OR = 0.077, 0.021-0.281, P < 0.001) are the relevant factors.ConclusionsCompared with other analgesic projects, PCIA or NCIA analgesia with morphine appears to be the safest and most effective postoperative analgesia program for pediatric patients who underwent neurosurgical operations.Trial registrationChinese Clinical Trial Registry. No: ChiCTR-IOC-15007676. Prospective registration. http://www.chictr.org.cn/index.aspx .

Project description:BACKGROUND:Pediatric musculoskeletal injuries cause moderate to severe pain, which should ideally be addressed upon arrival to the emergency department (ED). Despite extensive research in ED-based pediatric pain treatment, recent studies confirm that pain management in this setting remains suboptimal. The No OUCH study consist of two complementary, randomized, placebo-controlled trials that will run simultaneously for patients presenting to the ED with an acute limb injury and a self-reported pain score of at least 5/10, measured via a verbal numerical rating scale (vNRS). Caregiver/parent choice will determine whether patients are randomized to the two-arm or three-arm trial. In the two-arm trial, patients will be randomized to receive either ibuprofen alone or ibuprofen in combination with acetaminophen. In the three-arm trial, patients can also be randomized to a third arm where they would receive ibuprofen in combination with hydromorphone. This article details the statistical analysis plan for the No OUCH study and was submitted before the trial outcomes were available for analysis. METHODS/DESIGN:The primary endpoint of the No OUCH study is self-reported pain at 60?min, recorded using a vNRS. The principal safety outcome is the presence of any adverse event related to study drug administration. Secondary effectiveness endpoints include pain measurements using the Faces Pain Scale-Revised and the visual analog scale, time to effective analgesia, requirement of a rescue analgesic, missed fractures, and observed pain reduction using different definitions of successful analgesia. Secondary safety outcomes include sedation measured using the Ramsay Sedation Score and serious adverse events. Finally, the No OUCH study investigates the reasons given by the caregiver for selecting the two-arm (Non-Opioid) or three-arm (Opioid) trial, caregiver satisfaction, physician preferences for analgesics, and caregiver comfort with at-home pain management. DISCUSSION:The No OUCH study will inform the relative effectiveness of acetaminophen and hydromorphone, in combination with ibuprofen, and ibuprofen alone as analgesic agents for patients presenting to the ED with an acute musculoskeletal injury. The data from these trials will be analyzed in accordance with this statistical analysis plan. This will reduce the risk of producing data-driven results and bias in our reported outcomes. TRIAL REGISTRATION:ClinicalTrials.gov NCT03767933 . Registered on December 7, 2018.

Project description:BACKGROUND:The Prophylactic hypOthermia to Lessen trAumatic bRain injury-Randomised Controlled Trial (POLAR-RCT) will evaluate whether early and sustained prophylactic hypothermia delivered to patients with severe traumatic brain injury improves patient-centred outcomes. METHODS:The POLAR-RCT is a multicentre, randomised, parallel group, phase III trial of early, prophylactic cooling in critically ill patients with severe traumatic brain injury, conducted in Australia, New Zealand, France, Switzerland, Saudi Arabia and Qatar. A total of 511 patients aged 18-60 years have been enrolled with severe acute traumatic brain injury. The trial intervention of early and sustained prophylactic hypothermia to 33 °C for 72 h will be compared to standard normothermia maintained at a core temperature of 37 °C. The primary outcome is the proportion of favourable neurological outcomes, comprising good recovery or moderate disability, observed at six months following randomisation utilising a midpoint dichotomisation of the Extended Glasgow Outcome Scale (GOSE). Secondary outcomes, also assessed at six months following randomisation, include the probability of an equal or greater GOSE level, mortality, the proportions of patients with haemorrhage or infection, as well as assessment of quality of life and health economic outcomes. The planned sample size will allow 80% power to detect a 30% relative risk increase from 50% to 65% (equivalent to a 15% absolute risk increase) in favourable neurological outcome at a two-sided alpha of 0.05. DISCUSSION:Consistent with international guidelines, a detailed and prospective analysis plan has been developed for the POLAR-RCT. This plan specifies the statistical models for evaluation of primary and secondary outcomes, as well as defining covariates for adjusted analyses and methods for exploratory analyses. Application of this statistical analysis plan to the forthcoming POLAR-RCT trial will facilitate unbiased analyses of these important clinical data. TRIAL REGISTRATION:ClinicalTrials.gov, NCT00987688 (first posted 1 October 2009); Australian New Zealand Clinical Trials Registry, ACTRN12609000764235 . Registered on 3 September 2009.

Project description:BackgroundTo meet the surging demands for intubation and invasive ventilation as more COVID-19 patients begin their recovery, clinicians are challenged to find an ultra-brief and minimally invasive screen for postextubation dysphagia predicting feeding-tube dependence persisting for 72 h after extubation.MethodsThis study examined the predictive validity of a two-item swallowing screen on feeding-tube dependence over 72 h in patients following endotracheal extubation. Intensive-care-unit (ICU) patients (≥ 20 years) successfully extubated after ≥ 48 h endotracheal intubation were screened by trained nurses using the swallowing screen (comprising oral stereognosis and cough-reflex tests) 24 h postextubation. Feeding-tube dependence persisting for 72 h postextubation was abstracted from the medical record by an independent rater. To verify the results and cross-check whether the screen predicted penetration and/or aspiration during fiberoptic endoscopic evaluation of swallowing (FEES), participants agreeing to receive FEES were analyzed within 30 min of screening.ResultsThe results showed that 95/123 participants (77.2%) failed the screen, which predicted ICU patients' prolonged (> 72 h) feeding-tube dependence, yielding sensitivity of 0.83, specificity of 0.35, and accuracy of 0.68. Failed-screen participants had 2.96-fold higher odds of feeding-tube dependence (95% CI, 1.13-7.76). For the 38 participants receiving FEES, the swallowing screen had 0.89 sensitivity to detect feeding-tube dependence and 0.86 sensitivity to predict penetration/aspiration, although specificity had room for improvement (0.36 and 0.21, respectively).ConclusionThis ultra-brief swallowing screen is sufficiently sensitive to identify high-risk patients for feeding-tube dependence persisting over 72 h after extubation. Once identified, a further assessment and care are indicated to ensure the prompt return of patients' oral feeding.Trial registrationNCT03284892, registered on September 15, 2017.

Dataset Information

Short-term use of remifentanil during endotracheal extubation for prophylactic analgesia in neurosurgical patients after craniotomy (SURE after Craniotomy Study): a study protocol and statistical analysis plan for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Short-term use of remifentanil during endotracheal extubation for prophylactic analgesia in neurosurgical patients after craniotomy (SURE after Craniotomy Study): a study protocol and statistical analysis plan for a randomised controlled trial.

Similar Datasets

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