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Hypertonic saline as a therapy for pediatric concussive pain: a randomized controlled trial of symptom treatment in the emergency department.

ABSTRACT: OBJECTIVE:Three-percent hypertonic saline (HTS) is a hyperosmotic therapy used in pediatric traumatic brain injury to treat increased intracranial pressure and cerebral edema. It also promotes plasma volume expansion and cerebral perfusion pressure, immunomodulation, and anti-inflammatory response. We hypothesized that HTS will improve concussive symptoms of mild traumatic brain injury. METHODS:The study was a prospective, double-blind, randomized controlled trial. Children, 4 to 7 years of age with a Glasgow Coma Scale score greater than 13, were enrolled from a pediatric emergency department following closed-head injury upon meeting Acute Concussion Evaluation criteria with head pain. Patients were randomized to receive 10 mL/kg of HTS or normal saline (NS) over 1 hour. Self-reported pain values were obtained using the Wong-Baker FACES Pain Rating Scale initially, immediately following fluids, and at 2 to 3 days of discharge. The primary outcome measure was change in self-reported pain following fluid administration. Secondary outcome measures were a change in pain and postconcussive symptoms within 2 to 3 days of fluid administration. We used an intention-to-treat analysis. RESULTS:Forty-four patients, ranging from 7 to 16 years of age with comparable characteristics, were enrolled in the study; 23 patients (52%) received HTS, and 21 (48%) received NS. There was a significant difference (P < 0.001) identified in the self-reported improvement of pain following fluid administration between the HTS group (mean improvement = 3.5) and the NS group (mean improvement = 1.1). There was a significant difference (P = 0.01) identified in the self-reported improvement of pain at 2 to 3 days after treatment between the HTS group (mean improvement = 4.6) and the NS group (mean improvement = 3.0). We were unable to determine a difference in other postconcussive symptoms following discharge. CONCLUSIONS:Three-percent HTS is more effective than NS in acutely reducing concussion pain in children.

SUBMITTER: Lumba-Brown A

PROVIDER: S-EPMC6404981 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Hypertonic saline as a therapy for pediatric concussive pain: a randomized controlled trial of symptom treatment in the emergency department.

Lumba-Brown Angela A Harley Jim J Lucio Simon S Vaida Florin F Hilfiker Mary M

Pediatric emergency care 20140301 3

<h4>Objective</h4>Three-percent hypertonic saline (HTS) is a hyperosmotic therapy used in pediatric traumatic brain injury to treat increased intracranial pressure and cerebral edema. It also promotes plasma volume expansion and cerebral perfusion pressure, immunomodulation, and anti-inflammatory response. We hypothesized that HTS will improve concussive symptoms of mild traumatic brain injury.<h4>Methods</h4>The study was a prospective, double-blind, randomized controlled trial. Children, 4 to ...[more]

PMID: 24583571

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Project description:The aim was to evaluate if the addition of video discharge instructions (VDIs) to usual verbal information improved the comprehension of information provided to caregivers of patients who consult for acute gastroenteritis (AGE). We conducted an open-label, parallel, randomized trial, enrolling patients who consulted for AGE at a tertiary hospital. First, caregivers answered a written test concerning AGE characteristics and management. They were randomly allocated to a control group, which received the usual verbal instructions, or to an intervention group, which additionally received VDI. After discharge, caregivers were contacted by telephone and answered the same test, satisfaction questions, and follow-up information. From September 2019 to March 2020, 139 patients were randomized, 118 completed follow-up. The mean score was 3.13 (SD 1.07) over 5 points in the initial test and 3.96 (SD 0.96) in the follow-up test. Patients in the intervention group had a greater improvement (1.17 points, SD 1.11) than those in the control group (0.47 points, SD 0.94, p < 0.001). In the follow-up test, 49.1% in the intervention group and 18.6% in the control group answered all questions correctly (p < 0.001). There were no significant differences in return visits. Caregivers gave high satisfaction scores regardless of the allocation group.Conclusion: Video instructions improve caregivers' understanding of discharge information.Trial registration: [NCT04463355, retrospectively registered July 9, 2020]. What is Known: • Poor comprehension of discharge instructions leads to incorrect treatment after discharge, increased readmissions and a reduction of caregivers' satisfaction. • Video discharge instructions are useful providing concise information independently of the patients' health literacy level or communication skills of the health care provider What is New: • The addition of video discharge instructions to verbal instructions improves caregivers' knowledge about AGE improved with respect to those who only receive verbal instructions • Video instructions do not add extra time to the emergency department visits.

Project description:ObjectivesTo evaluate the effect of a collaborative interdisciplinary pain assessment program on pain and health-related quality of life among individuals with chronic pain who frequently visit the emergency department (ED).MethodsIndividuals with chronic pain who frequented the ED (ie, ≥8 visits within the previous 12 months) were randomly assigned to a collaborative chronic pain management program or treatment as usual. Primary outcomes were change in physical function and visits to the ED from baseline to 12 months using validated measures. Secondary measures included physical and emotional functioning, insomnia, health-related quality of life, risk of aberrant opioid use, and health care use. Mixed model analyses of variances were used to evaluate intervention effectiveness among the whole sample (ie, using intention to treat principles) and individuals who completed more than 50% of follow-up assessments.ResultsOne hundred participants were assessed for eligibility and 46 patients were enrolled with 24 being randomized to intervention and 22 to treatment as usual (TAU). Eleven of the 24 patients randomized to the intervention were lost to follow-up and 3 withdrew participation. Two of the 22 patients randomized to TAU were lost to follow-up, and 7 withdrew. Although patients assigned to the intervention improved more rapidly on measures of pain and health related quality of life, both groups had similar improvements overall between baseline to 12 months. Average pain intensity reduction (numeric rating scale [SE]) was 4.63 (0.40) in the intervention and 4.82 (0.53) in the treatment as usual at the 12-month follow-up. A significant group × time interaction was present for risk of aberrant opioid use, with individuals in the intervention group reporting greater improvement in risk of aberrant opioid use by 12-month follow-up.ConclusionParticipation in an interdisciplinary program may accelerate improvements in pain- and health-related quality of life and reduce risk of aberrant opioid use to manage pain and related distress. Further research is needed to better understand and address barriers to engagement in chronic pain care.

Project description:ImportanceAcute bronchiolitis is the leading cause of hospitalization among infants. Previous studies, underpowered to examine hospital admission, have found a limited benefit of nebulized hypertonic saline (HS) treatment in the pediatric emergency department (ED).ObjectiveTo examine whether HS nebulization treatment would decrease the hospital admission rate among infants with a first episode of acute bronchiolitis.Design, setting, and participantsThe Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) study was a multicenter, double-blind randomized clinical trial on 2 parallel groups conducted during 2 bronchiolitis seasons (October through March) from October 15, 2012, through April 15, 2014, at 24 French pediatric EDs. Among the 2445 infants (6 weeks to 12 months of age) assessed for inclusion, 777 with a first episode of acute bronchiolitis with respiratory distress and no chronic medical condition were included.InterventionsTwo 20-minute nebulization treatments of 4 mL of HS, 3%, or 4 mL of normal saline (NS), 0.9%, given 20 minutes apart.Main outcomes and measuresHospital admission rate in the 24 hours after enrollment.ResultsOf the 777 infants included in the study (median age, 3 months; interquartile range, 2-5 months; 468 [60.2%] male), 385 (49.5%) were randomized to the HS group and 387 (49.8%) to the NS group (5 patients did not receive treatment). By 24 hours, 185 of 385 infants (48.1%) in the HS group were admitted compared with 202 of 387 infants (52.2%) in the NS group. The risk difference for hospitalizations was not significant according to the mixed-effects regression model (adjusted risk difference, -3.2%; 95% CI, -8.7% to 2.2%; P = .25). The mean (SD) Respiratory Distress Assessment Instrument score improvement was greater in the HS group (-3.1 [3.2]) than in the NS group (-2.4 [3.3]) (adjusted difference, -0.7; 95% CI, -1.2 to -0.2; P = .006) and similarly for the Respiratory Assessment Change Score. Mild adverse events, such as worsening of cough, occurred more frequently among children in the HS group (35 of 392 [8.9%]) than among those in the NS group (15 of 384 [3.9%]) (risk difference, 5.0%; 95% CI, 1.6%-8.4%; P = .005), with no serious adverse events.Conclusions and relevanceNebulized HS treatment did not significantly reduce the rate of hospital admissions among infants with a first episode of acute moderate to severe bronchiolitis who were admitted to the pediatric ED relative to NS, but mild adverse events were more frequent in the HS group.Trial registrationclinicaltrials.gov Identifier: NCT01777347.

Project description:IntroductionIn series of cases and animal models suffering hemorrhagic shock, the use of vasopressors has shown potential benefits regarding hemodynamics and tissue perfusion. Terlipressin is an analogue of vasopressin with a longer half-life that can be administered by bolus injection. We have previously observed that hypertonic albumin improves resuscitation following controlled hemorrhage in piglets. The aim of the present study was to analyze whether the treatment with the combination of terlipressin and hypertonic albumin can produce better hemodynamic and tissular perfusion parameters than normal saline or hypertonic albumin alone at early stages of hemorrhagic shock in an infant animal model.MethodsExperimental, randomized animal study including 39 2-to-3-month-old piglets. Thirty minutes after controlled 30 ml/kg bleed, pigs were randomized to receive either normal saline (NS) 30 ml/kg (n = 13), 5% albumin plus 3% hypertonic saline (AHS) 15 ml/kg (n = 13) or single bolus of terlipressin 15 μg/kg i.v. plus 5% albumin plus 3% hypertonic saline 15 ml/kg (TAHS) (n = 13) over 30 minutes. Global hemodynamic and tissular perfusion parameters were compared.ResultsAfter controlled bleed a significant decrease of blood pressure, cardiac index, central venous saturation, carotid and peripheral blood flow, brain saturation and an increase of heart rate, gastric PCO2 and lactate was observed. After treatment no significant differences in most hemodynamic (cardiac index, mean arterial pressure) and perfusion parameters (lactate, gastric PCO2, brain saturation, cutaneous blood flow) were observed between the three therapeutic groups. AHS and TAHS produced higher increase in stroke volume index and carotid blood flow than NS.ConclusionsIn this pediatric animal model of hypovolemic shock, albumin plus hypertonic saline with or without terlipressin achieved similar hemodynamics and perfusion parameters than twice the volume of NS. Addition of terlipressin did not produce better results than AHS.

Project description:ContextInhaled hypertonic saline is recommended as therapy for patients 6 years or older with cystic fibrosis (CF), but its efficacy has never been evaluated in patients younger than 6 years with CF.ObjectiveTo determine if hypertonic saline reduces the rate of protocol-defined pulmonary exacerbations in patients younger than 6 years with CF.Design, setting, and participantsThe Infant Study of Inhaled Saline in Cystic Fibrosis (ISIS), a multicenter, randomized, double-blind, placebo-controlled trial conducted from April 2009 to October 2011 at 30 CF care centers in the United States and Canada. Participants were aged 4 to 60 months and had an established diagnosis of CF. A total of 344 patients were assessed for eligibility; 321 participants were randomized; 29 (9%) withdrew prematurely.InterventionThe active treatment group (n = 158) received 7% hypertonic saline and the control group (n = 163) received 0.9% isotonic saline, nebulized twice daily for 48 weeks. Both groups received albuterol or levalbuterol prior to each study drug dose.Main outcome measuresRate during the 48-week treatment period of protocol-defined pulmonary exacerbations treated with oral, inhaled, or intravenous antibiotics.ResultsThe mean pulmonary exacerbation rate (events per person-year) was 2.3 (95% CI, 2.0-2.5) in the active treatment group and 2.3 (95% CI, 2.1-2.6) in the control group; the adjusted rate ratio was 0.98 (95% CI, 0.84-1.15). Among participants with pulmonary exacerbations, the mean number of total antibiotic treatment days for a pulmonary exacerbation was 60 (95% CI, 49-70) in the active treatment group and 52 (95% CI, 43-61) in the control group. There was no significant difference in secondary end points including height, weight, respiratory rate, oxygen saturation, cough, or respiratory symptom scores. Infant pulmonary function testing performed as an exploratory outcome in a subgroup (n = 73, with acceptable measurements at 2 visits in 45 participants) did not demonstrate significant differences between groups except for the mean change in forced expiratory volume in 0.5 seconds, which was 38 mL (95% CI, 1-76) greater in the active treatment group. Adherence determined by returned study drug ampoules was at least 75% in each group. Adverse event profiles were also similar, with the most common adverse event of moderate or severe severity in each group being cough (39% of active treatment group, 38% of control group).ConclusionAmong infants and children younger than 6 years with cystic fibrosis, the use of inhaled hypertonic saline compared with isotonic saline did not reduce the rate of pulmonary exacerbations over the course of 48 weeks of treatment.Trial registrationclinicaltrials.gov Identifier: NCT00709280.

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Hypertonic saline as a therapy for pediatric concussive pain: a randomized controlled trial of symptom treatment in the emergency department.

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Hypertonic saline as a therapy for pediatric concussive pain: a randomized controlled trial of symptom treatment in the emergency department.

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