Trial reportIndian journal of pediatrics2016
Efficacy of Single Dose Oral Paracetamol in Reducing Pain During Examination for Retinopathy of Prematurity: A Blinded Randomized Controlled Trial.
Trial report in Indian journal of pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Analgesia for retinopathy of prematurity screening: A systematic review.Pain practice : the official journal of World Institute of Pain · 2022Pooled it
- Paracetamol (acetaminophen) for prevention or treatment of pain in newborns.The Cochrane database of systematic reviews · 2020Pooled it
- Paracetamol (acetaminophen) for prevention or treatment of pain in newborns.The Cochrane database of systematic reviews · 2016Pooled it
- Trial
- Pharmacological pain and sedation interventions for the prevention of intraventricular hemorrhage in preterm infants on assisted ventilation - an overview of systematic reviews.The Cochrane database of systematic reviews · 2023Review
- Compared Methods for Reducing Stress in ROP Exams; Stake-Holding Examiner Perspective.Clinical ophthalmology (Auckland, N.Z.) · 2023Article
- Quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials.eLife · 2021Observational
- A Critical Review on the Relevance of Paracetamol for Procedural Pain Management in Neonates.Frontiers in pediatrics · 2020Review
- Morphine compared to placebo for procedural pain in preterm infants: safety, efficacy and equipoise.Journal of perinatology : official journal of the California Perinatal Association · 2019Article
- Systemic changes and adverse effects induced by retinopathy of prematurity screening.International journal of ophthalmology · 2016Article
- Retinopathy of Prematurity (ROP) and its Associated Pain.Indian journal of pediatrics · 2015Article
- Anesthesia in retinopathy of prematurity.Saudi journal of ophthalmology : official journal of the Saudi Ophthalmological SocietyArticle
- Efficacy of Oral Dextrose versus Acetaminophen versus Placebo on Pain Relief during Retinopathy of Prematurity Eye Examinations: A Randomized, Double-Blind Controlled Clinical Trial.Journal of current ophthalmologyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo investigate the efficacy of paracetamol in reducing pain during examination for retinopathy of prematurity (ROP) in preterm infants.
methodsA total of 114 infants undergoing eye examination for retinopathy of prematurity screening were prospectively randomized. Topical anesthetic (Proparacaine; Alcaine® drop 0.5%) was applied 30 s before the eye examination in all the infants. The infants in the intervention group (Group 1, n = 58) received 15 mg/kg of oral paracetamol, 60 min before the examination. The control group (Group 2, n = 56) received the same volume of sterile water per oral with an opaque syringe. Primary outcome measurement was pain assessed by Premature Infant Pain Profile (PIPP) score. Secondary outcome measurements were tachycardia (>180 bpm)/bradycardia (<100 bpm), desaturations (<85% for >10 s), and crying time.
resultsThe groups were similar for gestational age, birthweight or postnatal age at examination. The intervention group had a significantly lower mean PIPP score during eye examination, following insertion of the speculum [Group 1:12 (9-13) vs. Group 2:14 (13-15), p 0.001]. There were no significant differences between the groups with regard to crying time and the number of the patients with tachycardia/bradycardia and desaturation.
conclusionsOral paracetamol modestly reduces pain scores during eye examinations. Further cross-over trials on dose and frequency of paracetamol and combination of pharmacological with non-pharmacological approaches and paracetamol alone as a single agent in significant pain reduction are needed.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.