A systematic review of pain outcomes reported by randomised trials of hip and knee arthroplasty.

It is difficult to pool results from randomised clinical trials that report different outcomes. We want to develop a core set of pain-related outcomes after total hip or knee arthroplasty, the first stage of which is to systematically review published outcomes. We searched PubMed, Embase and CENTRAL for relevant trials to January 2020. We identified 165 outcomes from 565 trials with 50,668 participants, which we categorised into six domains: pain; analgesic consumption; quality of care; adverse events; mobility; and patient-reported outcome measures. The outcome in each domain reported by most trials was: visual analogue score for pain, 401 (71%); morphine consumption, 212 (38%); length of hospital stay, 166 (29%); nausea or vomiting, 425 (75%); range of motion, 173 (31%); and patient satisfaction score, 181 (32%). A primary outcome was reported in 281 (50%) trials: 101 (18%) trials reported consumption of rescue analgesics and 95 (17%) trials reported pain. We plan to publish a consensus on outcomes that should be reported in postoperative pain trials after hip or knee arthroplasty.

Determinants of lung function and airway hyperresponsiveness in asthmatic children.

BACKGROUND: Asthma patients exhibit an increased rate of loss of lung function. Determinants to such decline are largely unknown and the modifying effect of steroid therapy is disputed. This cross-sectional study aimed to elucidate factors contributing to such decline and the possible modifying effect of steroid treatment. METHODS: We analyzed determinants of lung function and airway hyperresponsiveness (AHR) in a Scandinavian study of 2390 subjects from 550 families. Families were selected for the presence of two or more asthmatic children as part of a genetic study, Scandinavian Asthma Genetic Study (SAGA). RESULTS: The primary analysis studied the association between the lung function and delay of inhaled corticosteroids (ICS) after asthma diagnosis among asthmatic children and young adults with a history of regular ICS treatment (N=919). FEV(1) percent predicted (FEV(1)% pred) was 0.25% lower per year of delay from diagnosis until treatment (p=0.039). This association was significantly greater in allergy skin prick test negative children. There was no significant influence of gender, age at asthma onset, or smoking. In the secondary analysis of the whole population of 2390 asthmatics and non-asthmatics, FEV(1)% pred was inversely related to having asthmatic siblings (-7.9%; p<0.0001), asthma diagnosis (-2.7%; p=0.0007), smoking (-3.5%; p=0.0027), and positive allergy skin prick test (-0.47% per test; p=0.012), while positively related to being of female gender (1.8%; p=0.0029). Risk of AHR was higher by having asthmatic siblings (OR 2.7; p<0.0001), being of female gender (OR 2.0; p<0.0001), and having asthma (OR 2.0; p<0.0001). CONCLUSIONS: These data suggest that lung function is lower in asthmatics with delayed introduction of ICS therapy, smoking, and positive allergy skin prick test. Lung function is lower and AHR higher in female asthmatics and subjects with asthmatic siblings or established asthma.

Changes in body water distribution during treatment with inhaled steroid in pre-school children.

PRIMARY OBJECTIVE: The study aimed to examine the changes in water distribution in the soft tissue during systemic steroid activity. RESEARCH DESIGN: A three-way cross-over, randomized, placebo-controlled, double-blind trial was used, including 4 weeks of fluticasone propionate pMDI 200 microg b.i.d. delivered via Babyhaler, budesonide pressurized metered dose inhaler (pMDI) 200 microg b.i.d. delivered via Nebuchamber and placebo. Spacers were primed before use. In total, 40 children aged 1-3 years, with mild intermittent asthma were included. Twenty-five of the children completed all three treatments. At the end of each treatment period body impedance and skin ultrasonography were measured. METHODS AND PROCEDURES: We measured changes in water content of the soft tissues by two methods. Skin ultrasonography was used to detect small changes in dermal water content, and bioelectrical impedance was used to assess body water content and distribution. MAIN OUTCOMES AND RESULTS: We found an increase in skin density of the shin from fluticasone as measured by ultrasonography (p = 0.01). There was a tendency for a consistent elevation of impedance parameters from active treatments compared to placebo although overall this effect was not statistically significant (0.1 < p < 0.2). However, sub-analyses indicated a significant effect on whole-body and leg impedance from budesonide treatment (p < 0.05). CONCLUSION: Decreased growth during inhaled steroid treatment seems to partly reflect generalized changes in body water.

Effect of electrostatic charge in plastic spacers on the lung delivery of HFA-salbutamol in children.

AIMS: The effect of the electrostatic charge in plastic spacers in vivo on drug delivery to the lung of hydrofluoroalkane (HFA) salbutamol spray was studied in children. METHODS: Five children, aged 7-12 years, were included in a 3-way crossover randomised single-blind trial. Salbutamol HFA spray was delivered on 3 different study days from plastic spacers with mouthpiece. Pre-treatment of the spacers differed between study days: (a) Non-electrostatic 350 ml Babyhaler (coated with benzalkonium chloride) (b) New 350 ml Babyhaler (rinsed in water), and (c) New 145 ml AeroChamber (rinsed in water). Plasma salbutamol was measured before and 5, 10, 15 and 20 min after inhalation of four single puffs of 100 microg salbutamol. Cmax and Cav (5-20min) were calculated as a reflection of lung dose. RESULTS: For Cmax: (A) Non-electrostatic Babyhaler 4.3 ng ml(-1) (B) New Babyhaler 1.9 ng ml(-1) (C) New AeroChamber 1.6 ng ml(-1): AvsB (95% CI for difference 0.5-4.5 ng ml(-1)), A vs C (95% CI for difference 0.7-4.8 ng ml(-1)). The geometric mean ratio for A:B was 2.4 fold, and for A:C was 2.9 fold. The values for Cav were similar with ratios for A:B of 2.4 fold, and A: C of 4.1 fold. The nonelectrostatic Babyhaler delivered a significantly (P<0.05) higher lung dose (for both Cmax and Cav) than either of the other two spacers. CONCLUSIONS: The electrostatic charge in plastic spacers reduces lung dose in children by more than two-fold. This is clinically significant and the use of potentially electrostatically charged spacers should be avoided.

A non-electrostatic spacer for aerosol delivery.

A pear shaped non-electrostatic spacer, composed of steel with a volume of 250 ml and equipped with a facemask containing integrated inlet and outlet valves for inspiration and expiration, was compared with three plastic spacers. The plastic spacers were primed with repeated puffs from a budesonide pressurised metered dose inhaler (p-MDI) to minimise the electrostatic charge on the plastic. The procedure prolonged the half life (t1/2) of the aerosol in the Nebuhaler from nine to 32 seconds. A normal cleaning procedure reduced the aerosol t1/2 back to baseline. The t1/2 of the aerosol in the metal spacer was 27 seconds and independent of the use of p-MDI. In vitro the maximum dose of budesonide from a p-MDI, expressed as a percentage of the nominal dose, was 56% from the non-electrostatic spacer, 61% from the Nebuhaler, 45% from the Babyhaler, and 30% from the AeroChamber. In 124 children, age 6 months to 6 years, suspected to have asthma the non-electrostatic spacer delivered a mean total dose of budesonide aerosol of 39% of the nominal dose, which was significantly higher than the Babyhaler (28%), the Nebuhaler (21%), and the AeroChamber (19%). These differences were most pronounced in children younger than 4 years. The improved dose delivery from the small volume non-electrostatic spacer is probably related to the non-electrostatic spacer material and the valves which assured unidirectional airflow from the spacer without adding any dead space in the inspiratory channel. The non-electro-static spacer should improve the cost effectiveness of aerosol treatment and, as the counteracting effects of proming and recharging of the plastic from cleaning are avoided, should deliver a more reliable dose.