Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial

Kawade, Anand; Dayma, Girish; Apte, Aditi; Roy, Sudipto; Gondhali, Arun; Juvekar, Sanjay; Bavdekar, Ashish

doi:10.1002/pne2.12068

Cited by 10 publications

(11 citation statements)

References 27 publications

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“…Exploratory outcomes include: (1) need for oxygen therapy according to local guidelines (usually oxygen saturation <90%) and doctor’s discretion; (2) readmission after discharge; (3) clinician-initiated switch to a different treatment from the one they were randomised to; (4) highest pCO 2 measured; (5) Respiratory Severity Score with heart rate measured after treatment or every 3 hours if randomised to no saline treatment 15 ( online supplemental file A2 ); (6) visible distress in the child during delivery of treatment (or every 3 hours if randomised to no saline treatment) using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale 16 17 ; (7) health-related quality of life (HR-QoL) 18 ( online supplemental file A1.1 ) and (8) parents’ satisfaction with the given treatment using a Likert scale ( online supplemental file A1.2 ).…”

Section: Discussionmentioning

confidence: 99%

Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial

Schmidt,

Daugberg,

Nygaard

et al. 2024

bmjpo

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IntroductionBronchiolitis is one of the most common reasons for hospital admissions in early childhood. As supportive treatment, some treatment guidelines suggest using nasal irrigation with normal saline (NS) to facilitate clearance of mucus from the airways. In addition, most paediatric departments in Denmark use nebulised NS for the same purpose, which can mainly be administered as inpatient care. However, no studies have ever directly tested the effect of saline in children with bronchiolitis.Methods and analysisThe study is an investigator-initiated, multicentre, open-label, randomised, controlled non-inferiority trial and will be performed at six paediatric departments in eastern Denmark. We plan to include 300 children aged 0–12 months admitted to hospital with bronchiolitis. Participating children are randomised 1:1:1 to nebulised NS, nasal irrigation with NS or no saline therapy. All other treatment will be given according to standard guidelines.The primary outcome is duration of hospitalisation, analysed according to intention-to-treat analysis using linear regression and Cox regression analysis. By including at least 249 children, we can prove non-inferiority with a limit of 12 hours admission, alpha 2.5% and a power of 80%. Secondary outcomes are need for respiratory support with nasal continuous positive airway pressure or high-flow oxygen therapy and requirement of fluid supplements (either by nasogastric tube or intravenous).Ethics and disseminationThis study may inform current practice for supportive treatment of children with bronchiolitis. First, if NS is found to be helpful, it may be implemented into global guidelines. If no effect of NS is found, we can stop spending resources on an ineffective treatment. Second, if NS is effective, but nasal irrigation is non-inferior to nebulisation, it may reduce the workload of nurses, and possible duration of hospitalisation because the treatment can be delivered by the parents at home.Trial registration numberNCT05902702.

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Section: Discussionmentioning

confidence: 99%

Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial

Schmidt,

Daugberg,

Nygaard

et al. 2024

bmjpo

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“…It has been used in this study considering its objectivity and ease of administrating in the younger age group children. [20][21][22] In this study, it was done by a trained nursing staff observing the procedure during vaccination at 15 min and 30 min thereafter. The differences in scores at the time of administration, 15 min or 30 min after vaccination, were compared among all three medicine groups to know the most efficacious intervention among all three groups.…”

Section: Drugs Dosagementioning

confidence: 99%

Efficacy of oral mefenamic acid versus paracetamol as a prophylactic analgesic for needle pain in children receiving vaccination: a three-arm, parallel, triple-blind, placebo-controlled MAP VaC randomized controlled trial

Pasi,

Babu,

Kallidoss

2023

Therapeutic Advances in Vaccines and Immunotherapy

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Background: Needle pain due to routine vaccination is an important factor contributing to low vaccine adherence and immunization coverage. Prophylactic oral analgesics can address this important issue of needle pain related to vaccination. Paracetamol and mefenamic acid are commonly used nonsteroidal anti-inflammatory drugs for pain relief, but there is little published literature on whether the same can be used for needle pain related to vaccination. Objectives: This study was planned to compare the efficacy of oral mefenamic acid and paracetamol over placebo as a prophylactic analgesic during vaccination and prophylactic antipyretic during the post-vaccination period. Designs: Three-arm, triple-blind, randomized controlled trial. Methods: This study was conducted at the outpatient department of a tertiary-level medical college in South India from January 2021 to June 2022. In this three-arm interventional trial, each arm had either a single dose of placebo or mefenamic acid (4 mg/kg/dose) or paracetamol (10 mg/kg/dose). These medicines were administered orally 30 min before vaccination to reduce needle pain. Main outcome and measures: Outcome was measured with the change of FLACC (Face, Leg, Activity, Cry, Consolability) scoring at the time of vaccination, subsequently at 15 and 30 min of vaccination in all three groups. Appearance of fever, grade of fever, and need for antipyretics 24 h after vaccination were also noted. Results: There was a significant difference in FLACC scores at the time of administration ( p = 0.010) and at 15 min ( p = 0.014) with mefenamic acid compared to placebo. Although the paracetamol group showed a difference when compared to the placebo, it was not significant at the time of administration ( p = 0.401), at 15 min ( p = 0.451), or 30 min ( p = 0.892) post-vaccination. The appearance of fever, grade of fever, and use of antipyretic up to 24 h post-vaccination had no significant difference among any of the three groups. Conclusion: Mefenamic acid was more potent than placebo for pre-vaccination pain prophylaxis in children. There was no difference in the appearance of fever and its grade among the three groups. The promising results from this trial warrant further large-scale studies to recommend a single oral dose of mefenamic acid to tackle needle pain related to vaccination in children to improve vaccine adherence and coverage. Trial registration: CTRI (Clinical trials registry-India) (CTRI/2021/01/030239). [Date of Commencement: 13 Jan 2021, Date of last recruitment: 30 June 2022 (now closed for new participants)]

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“…We would like to correspond on the publication “Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial”. 1 Nasopharyngeal swab collection caused significant distress, which worsened with age, according to Kawade et al. 1 The authors concluded that sample collectors should be properly trained, and parents should be encouraged to participate in the procedure.…”

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confidence: 99%

Perceived distress due to nasopharyngeal swab collection: Correspondence

Sookaromdee,

Wiwanitkit

2024

Paediatric and Neonatal Pain

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Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial

Abstract: This is an open access article under the terms of the Creat ive Commo ns Attri butio n-NonCo mmerc ial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Cited by 10 publications

References 27 publications

Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial

Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial

Efficacy of oral mefenamic acid versus paracetamol as a prophylactic analgesic for needle pain in children receiving vaccination: a three-arm, parallel, triple-blind, placebo-controlled MAP VaC randomized controlled trial

Perceived distress due to nasopharyngeal swab collection: Correspondence

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