A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Infant Vaccination Pain Management on Parental Knowledge Uptake

Aim: The aim of the study was to assess the severity of pain experienced by a newborn during a heel puncture for screening using the Newborn Pain Scale (NIPS), measure the heart rate and compare the effectiveness of non-pharmacological methods of pain control. Design: Randomized clinical trial. No experimental factors. The test was performed during routine screening. Surroundings: Provincial Specialist Hospital in Olsztyn. Patients/Participants: Pain was assessed in 90 full-term newborns. The newborns were rooming in with their mothers in the hospital. Interventions: Newborns were divided into three groups. Three different methods of pain relief were used: breastfeeding, 20% glucose administered orally and non-nutritional sucking. Main Outcome Measures: The primary pain outcome was measured using the NIPS and the secondary pain outcome measures (heart rate, oxygen saturation) were measured using a pulse oximeter. Results: During capillary blood sampling from the heel, most newborns, n = 56 (62.2%), experienced no pain or mild discomfort, severe pain occurred in n = 23 (25.6%) and moderate pain occurred in n = 11 (12.2%). No significant statistical differences were found between the degree of pain intensity and the intervention used to minimize the pain p = 0.24. Statistically significant relationships were demonstrated between heart rate variability and the degree of pain intensity (p = 0. 01). There were no statistically significant differences between the newborn’s pain intensity and the mother’s opinion on the effectiveness of breastfeeding in minimizing pain. Conclusions: This study did not answer the question of which pain management method used during the heel prick was statistically more effective in reducing pain. However, the results indicate that each of the non-pharmacological interventions (breastfeeding, oral glucose dosing and non-nutritive sucking) applied during heel puncture resulted in effective pain management in most of the newborns enrolled in the study. The relationship between heart rate variability and the severity of pain was confirmed. Mothers of newborns in the breastfeeding group were satisfied with the pain relief methods used in the child and the opportunity to console their newborn during painful procedures in a technologically invasive environment.

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Effect of Silymarin in the Treatment of Allergic Rhinitis

Otolaryngology ◽

10.1177/0194599811423504 ◽

2011 ◽

Vol 145 (6) ◽

pp. 904-909 ◽

Cited By ~ 10

Author(s):

Mehdi Bakhshaee ◽

Farahzad Jabbari ◽

Saeed Hoseini ◽

Reza Farid ◽

Mohammad Hadi Sadeghian ◽

...

Keyword(s):

Clinical Trial ◽

Allergic Rhinitis ◽

Randomized Clinical Trial ◽

Signs And Symptoms ◽

Study Group ◽

Positive Skin Prick Test ◽

Serum Ige ◽

Oxidative Stresses ◽

The Impact

Objective. Although the role of oxidative stresses has been confirmed in the pathophysiology of allergic rhinitis and the protective effect of silymarin against oxidative stresses has been proven in different organs, no study has yet been conducted on the impact of silymarin on allergic rhinitis treatment. Study Design. A randomized clinical trial study. Setting. Two tertiary referral centers with otorhinolaryngology–head and neck surgery and allergy and immunology departments. Patients and Methods. In a randomized clinical trial, 94 patients with the signs and symptoms of allergic rhinitis and a positive skin prick test were selected and randomly divided into 2 groups. Their signs and symptoms, eosinophil percentage on nasal smear, serum IgE, and interleukin (IL-4, IL-5, interferon-γ) levels were recorded. The study group was treated with silymarin, whereas the control group received placebo, both for 1 month, along with routine antihistamine treatment. At the end of the treatment course, clinical and laboratory findings were statistically analyzed. Results. Sixty patients completed the trial. Based on the Sino-Nasal Outcome Test 20 (SNOT-20), a significant improvement in clinical symptom severity was observed in both groups (9.23 ± 5.14 vs 2.20 ± 2.69; P < .001), which was statistically significantly higher in the study group ( P < .001). Posttreatment percentage of nasal eosinophils and cytokine levels showed no significant difference ( P > .05). Rise in serum IgE level was seen after treatment with silymarin ( P = .003). Conclusion. Considering the statistically effective role of silymarin in alleviating the severity of allergic rhinitis symptoms, applying this herbal antioxidant along with other medications may result in better management.

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