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Results for “randomized crossover trial”

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PubMed2004

[Comparison of myocardial perfusion imaging by thallium-201 single-photon emission computed tomography with SUNY4001 (adenosine) and exercise--crossover clinical trial at multi-center].

We compared the ischemic diagnosis ability and adverse events of 201Tl myocardial perfusion imaging with SUNY4001 (adenosine) stress to that with exercise (ergometer) stress both on random crossover trial. Thirty one known or suspected chronic stable angina patients who are able to exercise and 10 healthy volunteers were enrolled for the trial. The early and delayed images were obtained by SPECT imaging. The concordance of diagnoses [ischemia vs. no ischemia] between the two types of stresses was 97.3% (36/37) [Kappa: 0.9068]. The sensitivity and specificity based on the exercise test were 100% (6/6) and 96.8% (30/31) respectively. The incidence of adverse events caused by SUNY4001 and the exercise were 44.7% (17/38) and 52.6% (20/38), respectively. Major adverse events caused by SUNY4001 were BP decrease, flushing and headache. And those by exercise were ST decrease, dyspnea and chest pain. None of the adverse events required the intervention or caused life-threatening complication in the trial. The trial showed that the ischemic diagnosis ability and safety of 201Tl scintigraphy with SUNY4001 stress are almost equal to those of the exercise stress that is considered as the standard stress method. We concluded that 201Tl imaging with SUNY4001 is safe and useful for detecting ischemic heart disease, especially for patients unable to exercise adequately.

Adenosine↗

PubMed1996

Modifying the fatty acid profile of dairy products through feedlot technology lowers plasma cholesterol of humans consuming the products.

Intake of milk and butter has been clearly associated with higher coronary heart disease rates in different countries and this is likely to be mediated by the hypercholesterolemic effect of dairy fat. Fat-modified dairy products are an innovation involving a technology in which protected unsaturated lipids are fed to ruminants resulting in milk and tissue lipids with reduced saturated fatty acids. We examined the impact of these novel dairy fats on plasma lipids in a human dietary trial. Thirty-three men and women participated in an 8-wk randomized crossover trial comparing fat-modified with conventional dairy products. The trial consisted of a 2-wk low-fat baseline period followed by two 3-wk intervention phases. During the test periods, the fat-modified products resulted in a significant 0.28-mmol/L (4.3%) lowering of total cholesterol (P < 0.001). Most of this decrease was in LDL cholesterol, which decreased by 0.24 mmol/L (P < 0.001) whereas HDL cholesterol and triacylglycerols remained essentially unchanged. This alteration in the fatty acid profile of dairy products, if applied to populations typical of developed Western countries, represents a potential strategy to lower the risk of coronary heart disease without any appreciable change in customary eating patterns.

Animal Feed↗

PubMed1984

A randomized trial on the effect of decreased dietary sodium intake on blood pressure in adolescents.

A randomized crossover trial on the effect of salt restriction on blood pressure was carried out involving 124 adolescents (mean age 16 years). Dietary sodium was reduced from approximately 110 to 45 mEq/24 h for a period of 24 days. Blood pressure was non-significantly lower at the end of the experimental diet for all participants. A slight (0.7 kg), yet statistically significant fall in weight was observed (P less than 0.05). Subgroup analysis demonstrated that participants whose body mass index was below the median had a statistically significant fall in systolic blood pressure (P less than 0.05); fall in weight and increase in heart rate were also more pronounced in the less obese individuals. It would appear that moderate sodium reduction does not have an overall short-term effect on blood pressure in normotensive adolescents. However, body size as reflected in body mass index may influence blood pressure response to sodium reduction.

Adolescent↗

PubMed2006

The rate of intestinal absorption of natural food folates is not related to the extent of folate conjugation.

BACKGROUND: Evidence is conflicting as to whether the bioavailability of food folates is influenced by the extent of their conjugation. OBJECTIVE: The objective was to compare the bioavailability of 3 representative food folate sources with various degrees of glutamylation-ie, egg yolk, spinach, and yeast, whose polyglutamyl folate content measured 0%, 50%, and 100%, respectively. DESIGN: In a randomized crossover trial, 13 male subjects, after a prestudy folate saturation procedure, received in random order either placebo or 500 mug total folate, which was provided as concentrated freeze-dried extract removed from the normal food matrix of egg yolk, spinach, or yeast. Blood samples (n = 10) were collected before and up to 10 h after treatments, which were administered at weekly intervals. RESULTS: A significant increase from baseline plasma folate concentrations was observed by 0.5 h after treatment with egg yolk folate or spinach folate and by 1 h after treatment with yeast folate, and the concentrations remained significantly elevated for 3-5 h; no plasma folate response was observed after placebo treatment. The overall responses, calculated as plasma folate area under the curve (AUC) for egg yolk, spinach, and yeast folate, were 122.6 +/- 23.6, 136.2 +/- 21.4, and 102.5 +/- 21.1 nmol . h/L, respectively. No significant differences in AUC were seen between monoglutamyl (egg yolk) folate and either of the polyglutamate-containing folates examined. CONCLUSION: These results suggest that the ratio of monoglutamate to polyglutamate in natural folates is not a factor that limits the extent of intestinal absorption of food folate.

Administration, Oral↗

PubMed1990

Differences in the skin surface pH and bacterial microflora due to the long-term application of synthetic detergent preparations of pH 5.5 and pH 7.0. Results of a crossover trial in healthy volunteers.

Skin cleansing preparations consisting of identical synthetic detergents but differing in pH-value (pH 5.5 and 7.0) were applied twice daily on the forehead and forearm of healthy volunteers in a randomized crossover trial. The skin surface pH was found to be significantly higher when the neutral preparation had been used, as was the propionibacterial count (p less than 0.05). The number of propionibacteria was significantly linked to the skin pH. Hence even minor differences in the pH of skin cleansing preparations seem to be of importance for the integrity of the skin surface. This should be taken into account when planning the formulation of optimal skin care products.

Adult↗

PubMed1996

Cardiac event recorders yield more diagnoses and are more cost-effective than 48-hour Holter monitoring in patients with palpitations. A controlled clinical trial.

OBJECTIVE: To compare the diagnostic yield and cost-effectiveness of transtelephonic event monitors with those of Holter monitoring in patients with intermittent palpitations. DESIGN: Randomized crossover trial. SETTING: Diagnostic service of a teaching hospital and surrounding primary care practices. PATIENTS: 43 patients with previously uninvestigated palpitations who were referred for Holter monitoring. MEASUREMENTS: Patients were randomly allocated to receive an event monitor or 48-hour Holter monitor and then to receive the other device. Event monitors were used for 3 months or until two recordings were obtained while symptoms occurred. The main end point was an electrogram recorded during symptoms. The incremental cost-effectiveness of obtaining a diagnostic rhythm strip from event monitors was compared with that of Holter monitoring. RESULTS: The mean (+/- SD) patient age was 45 +/- 19 years; 37 patients (88%) were women. Event monitors were twice as likely to provide a diagnostic rhythm strip electrocardiogram during symptoms as 48-hour Holter monitoring (29 patients [67%] and 15 patients [35%], respectively; P < 0.001). Event monitors detected 8 patients (19%) with clinically important arrhythmias (6 patients with supraventricular tachycardia and 2 with atrial fibrillation or flutter), whereas the Holter monitors detected no significant arrhythmia (P < 0.005). With the event monitors, most patients transmitted an electrocardiogram recording by 6 weeks. Event monitors were dominant and therefore more cost-effective than 48-hour Holter monitoring, resulting in a cost savings of $213 for each additional diagnostic rhythm strip obtained during symptoms. CONCLUSIONS: Holter monitoring is a poor diagnostic test for intermittent palpitations. Event recorders provide better data and are more cost-effective.

Adult↗

PubMed1986

Nutrient intake, blood pressure, serum and urinary prostaglandins and serum thromboxane B2 in a controlled trial with a lacto-ovo-vegetarian diet.

Fifty-nine healthy omnivores volunteered for a randomized crossover trial with a lacto-ovo-vegetarian (L-O-V) diet. Twenty-one 1-day diet records were kept throughout the project as a means of assessing food and nutrient intakes, and samples of serum and urine were assayed to evaluate change in prostanoid metabolism. While on the L-O-V diet subjects ate more vegetable protein, wholegrain cereals, polyunsaturated oils, fruits and vegetables, and avoided eating meat, fish or poultry. The L-O-V diet contained significantly more polyunsaturated fatty acids, fibre, vitamin C, vitamin E, magnesium, calcium and potassium, and less total protein, saturated fat, monounsaturated fat and vitamin B12 than the control omnivore diet. Changes in nutrient intakes were subjected to principal components analysis to identify dimensions of change in nutrient intakes. Three Factors accounted for 83% of the total variation in dietary intake. Blood pressure changes were significantly and negatively (F = 17.4, P less than 0.001 for systolic; F = 6.09, P = 0.02 for diastolic pressure) related to individual scores for only one Factor--that representing an increase in intake of polyunsaturated fat, fibre, vitamin C, vitamin E, calcium and magnesium, and a fall in intake of protein and vitamin B12. Blood pressure changes were unrelated to change in body weight or sodium intake. Serum and urinary prostanoids were not affected by eating the L-O-V diet.

Blood Pressure↗

PubMed2002

Effect of low- and high-dose levothyroxine on thyroid nodule volume: a crossover placebo-controlled trial.

OBJECTIVE: The efficacy and the effective dose of levothyroxine suppressive therapy in the treatment of benign thyroid nodules are controversial. In this study, we aimed to determine the response of solitary thyroid nodules to low- or high-level TSH suppression in a placebo-controlled, randomized crossover trial. DESIGN: Forty-nine patients with solitary thyroid nodules on palpation were randomized to high-level and low-level TSH suppression groups. In each group, patients were further randomized to placebo and active levothyroxine subgroups. Patients in each subgroup were crossed over to placebo or active levothyroxine at the end of the first year and were then followed up for an additional year. METHODS: TSH levels were suppressed to 0.4-0.6 mIU/ml and < or = 0.01 mIU/ml in the low-level and high-level TSH suppression groups, respectively. Nodule volumes were measured at baseline and every 6 months after the desired level of TSH was reached if the patients were in the active levothyroxine treatment group or every 6 months if they were in the placebo group. RESULTS: In high-level TSH suppression groups, nodule volume decreased significantly at the end of the active treatment periods (4.99 +/- 2.02 ml vs. 3.20 +/- 1.50 ml, P < 0.01, in Group 1; and 3.72 +/- 1.79 ml to 2.05 +/- 0.64 ml, P < 0.001, in Group 2). In the low-level TSH suppression groups, nodule volume also decreased significantly at the end of the active treatment periods (4.43 +/- 1.76 ml vs. 3.04 +/- 1.32, P < 0.05, in Group 3; and 3.59 +/- 0.89 ml to 2.22 +/- 0.59 ml, P < 0.01, in Group 4). Nodule volumes regained their original volumes during the placebo treatment periods. The percentage decline in clinically relevant nodule volume reduction (> or = 50%) was similar in the low-level and high-level TSH suppression groups. CONCLUSION: Low- and high-level TSH suppression were equally effective in reducing nodule volume and thus, considering the complications of high-level TSH suppression, low-level TSH suppression should be used if one considers levothyroxine suppressive therapy to reduce thyroid nodule size.

Adult↗

PubMed2002

A randomized trial of continuous subcutaneous insulin infusion and intensive injection therapy in type 1 diabetes for patients with long-standing poor glycemic control.

OBJECTIVE: To assess in a randomized crossover trial the efficacy of continuous subcutaneous insulin infusion in improving glycemic control and health-related quality of life in type 1 diabetic patients with long-standing poor glycemic control. RESEARCH DESIGN AND METHODS: A total of 79 patients in 11 Dutch centers were randomized to 16 weeks of continuous subcutaneous insulin infusion followed by 16 weeks intensive injection therapy or the reverse order. Glycemic control was assessed by HbA(1c), self-reported hypoglycemic events, and blood glucose memory meter read outs. Changes in quality of life were assessed by self-report questionnaires administered at baseline and 16 weeks. RESULTS: As the drop-out rate after crossover was high (17 of 79 patients [22%]), we analyzed the trial as a parallel clinical trial, using data of the first half of the crossover phase only. At 16 weeks, mean HbA(1c) was 0.84% (95% CI -1.31 to -0.36) lower in the continuous subcutaneous insulin infusion group compared with the insulin injection group (P = 0.002). Stability of blood glucose self-measurement values, expressed as SD of the nine-point blood glucose profiles, improved in the insulin pump group by 29.3 +/- 41.1 vs. 8.2 +/- 36.5% in the injection group (P = 0.039). The number of mild hypoglycemic episodes per patient-week was 0.99 (95% CI 0.11-1.87) higher in the insulin pump group (P = 0.028). Weight gain was similar in both groups. Scores on the Short-Form 36-Item subscales 'general health' and 'mental health' improved in the continuous subcutaneous insulin infusion group, compared with stable values in the injection group (P = 0.048 and 0.050, respectively). CONCLUSIONS: Continuous subcutaneous insulin infusion improves glycemic control and some aspects of health-related quality of life in patients with a history of long-term poor glycemic control.

Adult↗

PubMed1998

Prospective evaluation of vitamin E for hot flashes in breast cancer survivors.

PURPOSE: Hot flashes represent a substantial clinical problem for some breast cancer survivors. Although estrogen or progesterone preparations can alleviate these symptoms in many patients, concern remains regarding the use of hormonal preparations in such women. Thus, there is a perceived need for nonhormonal treatments for hot flashes for breast cancer survivors. Based on anecdotal evidence that vitamin E was helpful, we designed a trial to investigate this matter. METHODS: We developed and conducted a placebo-controlled, randomized, crossover trial where, after a 1 week baseline period, patients received 4 weeks of vitamin E 800 IU daily, then 4 weeks of an identical-appearing placebo, or vice versa. Diaries were used to measure potential toxicities and hot flashes during the baseline week and the two subsequent 4-week treatment periods. RESULTS: The 120 patients evaluated for toxicity failed to show any. The 105 patients who finished the first treatment period showed a similar reduction in hot flash frequencies (25% v 22%; P = .90) for the two study arms. A crossover analysis, however, showed that vitamin E was associated with a minimal decrease in hot flashes (one less hot flash per day than was seen with a placebo) (P < or = .05). At the study end, patients did not prefer vitamin E over the placebo (32% v 29%, respectively). CONCLUSION: Although this trial was able to show a statistically significant hot flash reduction with vitamin E compared to a placebo, the clinical magnitude of this reduction was marginal.

Adolescent↗

PubMed2002

Randomized trial of an internet curriculum on herbs and other dietary supplements for health care professionals.

PURPOSE: Herbs and dietary supplements are widely used, and there is an urgent need to educate health professionals about their risks and benefits. The Internet provides an innovative way of educating busy health professionals. This study assessed the impact of an Internet-based curriculum on health professionals' knowledge, confidence, and clinical practices related to herbs and dietary supplements. METHOD: The study was a randomized crossover trial involving physicians, pharmacists, advanced practice nurses, and dietitians. Participants were invited by e-mail and randomly assigned to immediate intervention versus waiting-list groups (n = 537). The curriculum lasted ten weeks and consisted of 20 case-based modules, each involving one multiple-choice or true-or-false question and its answer, links to reliable Internet sources of additional information, and a moderated listserv discussion group. Participants were surveyed about their knowledge, confidence, and communication related to herbs and dietary supplements on enrollment, after the immediate intervention group had completed the curriculum, and after the waiting-list group completed the curriculum. RESULTS: Baseline scores for knowledge, confidence, and communication were similar in the two groups. At the first follow-up, there was greater improvement in scores for all three areas in the immediate intervention group than in the waiting-list group (improvement for knowledge, 3.0 versus 1.4; confidence, 2.6 versus 0.6; communication, 0.21 versus -0.1, p <.01 for all comparisons). After all participants had received the curriculum, scores for both groups were significantly better than at baseline and similar to one another. CONCLUSION: Internet-based education about herbs and dietary supplements for diverse health professionals is feasible and results in significant and sustained improvements in knowledge, confidence, and communication practices.

Adult↗

PubMed2006

Early results of the treatment of internal hemorrhoid disease by infrared coagulation and elastic banding: a prospective randomized cross-over trial.

BACKGROUND: Rubber band ligation (RBL) is probably the most commonly performed nonsurgical therapy for hemorrhoidal disease. Infrared coagulation (IRC) is one of the most recent advances based on the use of "heat". Recent studies have demonstrated similar efficacy for both modalities. This prospective randomized crossover trial compared IRC and RBL for pain, complications, effectiveness, and patient satisfaction and preference in the treatment of internal hemorrhoids (IH). METHODS: Patients were randomized to receive either RBL (Group A) or IRC (Group B) for treatment of the first hemorrhoid; in a second procedure two weeks later, patients underwent the other procedure on the second hemorrhoid, thereby serving as their own control. The procedure preferred by the patient was employed two weeks later for the third hemorrhoid. Post-treatment pain was evaluated on a visual analog scale and on the basis of the percentage of patients requiring analgesics. Bleeding and early outcome of treatment were also recorded, together with the patient's satisfaction. RESULTS: A total of 94 patients were included in this study (47 patients in each group). At 30 minutes and 6 hours after treatment, pain scores were significantly higher in patients treated with RBL than in those treated with IRC (p<0.01). There was no significant difference in pain scores between the two procedures immediately and 24 hours after the procedures (p<0.05). After 72 hours and one week, the pain scores for RBL and IRC were similar. The percentage of patients using analgesics was significantly higher in RBL group than in IRC group at 6 hours (29.6% vs. 19.2%, respectively; p<0.05) and 24 hours (22.5% vs. 13.5%, respectively; p<0.05) after treatment. However, significant differences were not noted at 72 hours (12.7% vs. 6.4%; p<0.05) and one week (5.6% vs. 7.1%; p>0.05) after the procedures. There were significantly higher incidences of bleeding immediately, 6 hours, and 24 hours after RBL compared to IRC (immediate: 32.4% vs. 4.3%; 6 hours: 13.4% vs. 3.6%, 24 hours: 26.8% vs. 10.2%, respectively; p<0.01). However, there were no significant differences noted regarding the incidence of bleeding between the two groups at 72 hours. Complications were more likely after RBL than IRC, however this difference was not significant (p>0.05). Overall, 91 patients (96.8%) were successfully treated and 93 patients (99%) were very satisfied with the treatment. In the third treatment session, 50% of patients selected RBL and 50% chose IRC. CONCLUSIONS: Both RBL and IRC were well-accepted and highly efficacious methods for the treatment of IH; in addition, both procedures were associated with relatively minor complications. However, RBL was associated with more pain than IRC in the 24-hour postoperative period.

Adult↗

PubMed2026

Efficacy and Safety of Mechanical Insufflation-Exsufflation in Invasively Ventilated Critically Ill Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Mechanical insufflation-exsufflation (MI-E) is increasingly used in invasively ventilated adults in the intensive care unit (ICU), yet its therapeutic efficacy and safety remain uncertain due to inconsistent evidence. AIM: To synthesize evidence on the clinical efficacy and safety of MI-E in this population and to examine methodological and clinical heterogeneity underlying reported outcomes. STUDY DESIGN: A systematic review and meta-analysis of randomized studies (including RCTs and randomized crossover trials), conducted following PRISMA guidelines, with risk of bias assessed using the Cochrane risk-of-bias tool. RESULTS: Five randomized controlled trials involving 310 patients were included. Meta-analysis showed that mechanical insufflation-exsufflation (MI-E) significantly increased sputum clearance (SMD = 0.63, 95% CI, 0.32-0.93; p < 0.00011; I2 = 38%) without affecting oxygenation (MD = 0.28, 95% CI, -0.53 to 1.09; p = 0.50; I2 = 9%). Data on respiratory mechanics, ventilation duration and ICU stay could not be pooled. No serious adverse events were reported. CONCLUSIONS: MI-E significantly improves sputum clearance in invasively ventilated critically ill adults, with no severe adverse events reported in the included studies. Its effects on other outcomes remain inconclusive due to limited data and heterogeneity. Standardized protocols and larger trials are needed. RELEVANCE TO CLINICAL PRACTICE: Clinicians may consider MI-E as an adjunct for respiratory secretion management. Application should be guided by structured patient assessment and individualized parameter adjustment. Future research should standardize interventions and target well-defined patient subgroups to inform clear practice guidelines. TRIAL REGISTRATION: The review protocol was registered in the International Prospective Register of Systematic Reviews, with registration number CRD42023403299.

Humans↗

PubMed1992

Adenosine versus verapamil in the treatment of supraventricular tachycardia: a randomized double-crossover trial.

The safety and efficacy of verapamil and adenosine in the acute termination of supraventricular tachycardia were compared in a randomized double-crossover trial. Of 32 eligible patients with either spontaneous or induced narrow complex tachycardia, seven (22%) patients experienced conversion to sinus rhythm with carotid sinus massage. The other 25 patients were randomly assigned to receive either adenosine (n = 14) or verapamil (n = 11). Relative drug efficacies were 100% for adenosine versus 73% for verapamil, p = NS. Adenosine given at less than or equal to 120 micrograms/kg caused conversion in 12 (86%) of 14 patients. The other two patients required 20 mg adenosine for conversion. After conversion the systolic blood pressure increased significantly in the adenosine group but not in the verapamil group. Reinitiation of tachycardia occurred in two (14%) of 14 patients randomized to the adenosine group. Serious adverse hemodynamic effects were observed in one (9%) of 11 patients randomized to verapamil. The incidence of conversion arrhythmias was similar in both treatment groups (adenosine 57%, verapamil 50%, p = NS).

Adenosine↗

PubMed1988

Long-term prospective trial of low-dose methotrexate in rheumatoid arthritis.

Twenty-six patients with severe rheumatoid arthritis who had completed a randomized crossover trial of methotrexate elected to continue to receive the drug in a long-term prospective study. At 36 months, 16 patients remained in the study. Over this period of time, significant improvement was noted in the number of painful and swollen joints, physician and patient global assessments, erythrocyte sedimentation rate, and prednisone dose. Adverse reactions occurred in 16 patients (62%), including nausea, alopecia, headache, stomatitis, herpes zoster, and diarrhea. Mild leukopenia (3 patients), thrombocytopenia (3 patients), and elevated transaminase levels (8 patients) resolved with temporary drug discontinuation. No patient withdrew due to drug toxicity. Liver biopsy specimens in 17 patients after 24 months of treatment showed no evidence of fibrosis or cirrhosis. A significant increase in the percentage of T3 and T4 blood cells and increases in lymphocyte proliferation to concanavalin A and purified protein derivative of tuberculin were found after 2 years of therapy. Our findings indicate that methotrexate has remained effective over 36 months of therapy, with acceptable toxicity levels and no evidence of systemic immunosuppression.

Aged↗

PubMed2007

Effects of estradiol with micronized progesterone or medroxyprogesterone acetate on risk markers for breast cancer in postmenopausal monkeys.

The addition of the synthetic progestin medroxyprogesterone acetate (MPA) to postmenopausal estrogen therapy significantly increases breast cancer risk. Whether this adverse effect is specific to MPA or characteristic of all progestogens is not known. The goal of this study was to compare the effects of oral estradiol (E2) given with either MPA or micronized progesterone (P4) on risk biomarkers for breast cancer in a postmenopausal primate model. For this randomized crossover trial, twenty-six ovariectomized adult female cynomolgus macaques were divided into social groups and rotated randomly through the following treatments (expressed as equivalent doses for women): (1) placebo; (2) E2 (1 mg/day); (3) E2 + P4 (200 mg/day); and (4) E2 + MPA (2.5 mg/day). Hormones were administered orally, and all animals were individually dosed. Treatments lasted two months and were separated by a one-month washout period. The main outcome measure was breast epithelial proliferation, as measured by Ki67 expression. Compared to placebo, E2 + MPA resulted in significantly greater breast proliferation in lobular (P < 0.01) and ductal (P < 0.01) epithelium, while E2 + P4 did not. Intramammary gene expression of the proliferation markers Ki67 and cyclin B1 was also higher after treatment with E2 + MPA (P < 0.01) but not E2 + P4. Both progestogens significantly attenuated E2 effects on body weight, endometrium, and the TFF1 marker of estrogen receptor activity in the breast. These findings suggest that oral micronized progesterone has a more favorable effect on risk biomarkers for postmenopausal breast cancer than medroxyprogesterone acetate.

Animals↗

PubMedDate not supplied

The efficacy of developmentally sensitive interventions and sucrose for relieving procedural pain in very low birth weight neonates.

BACKGROUND: Procedural pain management for very low birth weight (VLBW) neonates has been minimal or nonexistent in most neonatal intensive care units (NICUs). OBJECTIVES: To compare the efficacy of developmentally sensitive behavioral interventions (nonnutritive sucking via a pacifier, positioning) and sucrose for relieving procedural pain in VLBW infants and to determine the influence of contextual factors (gestational age, postnatal age, birth weight, severity of illness, frequency of painful procedures) on pain response. METHOD: In a prospective randomized crossover trial, pain was assessed in 122 VLBW neonates using the Premature Infant Pain Profile following four randomly ordered interventions during consecutive routine heel lance procedures. RESULTS: Significant differences in pain existed among treatment interventions (F = 16.20, p < .0001). The pacifier with sucrose (F = 24.09, p < .0001) and pacifier with sterile water (F = 9.00, p = .003) significantly reduced pain. Prone positioning did not decrease pain (F = 2.24, p = .137). Frequency of painful procedures approached significance in influencing pain response (F = 3.59, p = .01). CONCLUSIONS: The most efficacious interventions for reducing pain from single painful events were the pacifier with sucrose and the pacifier with sterile water. Research on the efficacy and safety of implementing these interventions, alone and in combination, for repeated painful procedures is needed. In addition, research is needed on the influence of implementing these interventions on pain response and clinical outcomes (e.g., health status and neurodevelopmental status) in VLBW neonates in the NICU.

Blood Specimen Collection↗

PubMed1981

A comparative trial of tiaprofenic acid ('Surgam') versus aspirin in the control of pain following injury.

A double-blind, non-crossover, randomized trial was carried out in 50 patients suffering from pain following trauma to compare the therapeutic effectiveness and tolerance of 200 mg tiaprofenic acid and 600 mg aspirin given 3-times daily for 7 days. Both drugs were found to be equally effective in relieving pain but side-effects were significantly fewer in the tiaprofenic acid-treated group.

Adolescent↗