Trial reportBMC pediatrics2007
How effective is tetracaine 4% gel, before a venipuncture, in reducing procedural pain in infants: a randomized double-blind placebo controlled trial.
Trial report in BMC pediatrics, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
12 citing papers in PubMed, 4 syntheses or guidelines pooled it, 37 citations in OpenAlex.
- Topical anaesthesia for needle-related pain in newborn infants.The Cochrane database of systematic reviews · 2017Pooled it
- Blood sampling in infants (reducing pain and morbidity).BMJ clinical evidence · 2011Pooled it
- Guidelines for procedural pain in the newborn.Acta paediatrica (Oslo, Norway : 1992) · 2009Guideline
- Blood sampling in infants (reducing pain and morbidity).BMJ clinical evidence · 2009Pooled it
- Trial
- Use of Topical Analgesics in Neonates.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Turkish Neonatal Society guideline on the neonatal pain and its management.Turk pediatri arsivi · 2018Article
- Improving the treatment of infant pain.Current opinion in supportive and palliative care · 2017Review
- Nociceptive brain activity as a measure of analgesic efficacy in infants.Science translational medicine · 2017Article
- A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants: Trial protocol.Wellcome open research · 2016Article
- Pain management in newborns.Clinics in perinatology · 2014Review
- Pain management in newborns: from prevention to treatment.Paediatric drugs · 2010Review
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 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProcedural pain relief is sub-optimal in neonates. Topical tetracaine provides pain relief in children. Evidence of its efficacy and safety in neonates is limited. The objective of this study was to assess the efficacy and safety of topical tetracaine on the pain response of neonates during a venipuncture.
methodsMedically stable infants greater than or equal to 24 weeks gestation, requiring a venipuncture, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. Participants received oral sucrose if they met local eligibility criteria. The venipuncture was performed according to a standard protocol. A medium effect size in the pain score (corresponding to about 2 point difference in the PIPP score) was considered clinically significant, leading to a sample size of 142 infants, with 80% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test.
resultsOne hundred and forty two infants were included, 33 +/- 4 weeks gestation, 2100 +/- 900 grams and 6 +/- 3 days of age. There was almost no difference in PIPP scores at 1 minute between groups (mean difference -0.09; 95% confidence interval [CI]: -1.68 to 1.50; P = . 91). Similarly, there were no differences in PIPP scores during the 2nd, 3rd and 4th minute. Duration of cry did not differ between the groups (median difference, 0; 95% CI, -3 to 0; P = . 84). The majority of infants in both groups received sucrose 24%. Sucrose had a significant effect on the PIPP score, as assessed by an ANOVA model (p = 0.0026). Local skin erythema was observed transiently in 11 infants (7 in the tetracaine and 4 in the placebo group). No serious side effect was observed.
conclusionTetracaine did not significantly decrease procedural pain in infants undergoing a venipuncture, when used in combination with routine sucrose administration.
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Registered trials
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