ArticlePediatrics2012
Pediatric analgesic clinical trial designs, measures, and extrapolation: report of an FDA scientific workshop.
Article in Pediatrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 39 papers, 6 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.
Randomized Controlled Trial Comparing Ultrasound-guided Pudendal Nerve Block to Ultrasound-guided Penile Nerve Block for Analgesia Following Pediatric Circumcision
Respiratory Effect of the LISA (Less Invasive Surfactant Administration) Method With Sedation by Propofol Versus Absence of Sedation: Double-blind Comparative Randomized Clinical Trial.
Who cites it
39 citing papers in PubMed, 6 syntheses or guidelines pooled it, 98 citations in OpenAlex.
- Placebo in Paediatric Clinical Trials: Systematic Literature Review and Framework-Based Synthesis.Journal of paediatrics and child health · 2026Pooled it
- Perioperative pain management for cleft palate surgery: a systematic review and procedure-specific postoperative pain management (PROSPECT) recommendations.Regional anesthesia and pain medicine · 2024Pooled it
- Pooled it
- Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development.Journal of clinical pharmacology · 2016Pooled it
- Immediate rescue designs in pediatric analgesic trials: a systematic review and meta-analysis.Anesthesiology · 2015Pooled it
- Opioid-sparing effects of perioperative paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) in children.Paediatric anaesthesia · 2013Pooled it
- Trial
- Pediatric Extrapolation in Neuropsychiatric Drug Development: Leveraging Pharmacokinetic and Pharmacodynamic Strategies to Facilitate FDA Approvals.Clinical pharmacology and therapeutics · 2026Review
- Prolonged magnesium sulfate infusion as adjuvant analgesia in postoperative transplant patients in the pediatric ICU: Preliminary results of a feasibility study.Paediatric & neonatal pain · 2024Article
- Rescue designs in analgesic trials from 0 to 2 years of age: scoping review.Pediatric research · 2024Article
- Evaluation of topical morphine for treatment of oral mucositis in cancer patients.British journal of pain · 2021Article
- Outcomes of the Pediatric Development Plan of Tapentadol.Journal of pain research · 2021Review
- A child in pain: A psychologist's perspective on changing priorities in scientific understanding and clinical care.Paediatric & neonatal pain · 2020Review
- Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA).BMC pediatrics · 2020Article
- Developing a pediatric pain data repository.JAMIA open · 2020Article
- Post-Cardiotomy Parasternal Nerve Block with Bupivacaine may be Associated with Reduced Post-Operative Opioid Use in Children: A Retrospective Cohort Study.Children (Basel, Switzerland) · 2020Article
- Pediatric Clinical Endpoint and Pharmacodynamic Biomarkers: Limitations and Opportunities.Paediatric drugs · 2020Review
- Tapentadol Prolonged Release for Long-Term Treatment of Pain in Children.Journal of pain research · 2020Article
- 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
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors at 20 institutions in 2 countries.
Funding
Abstract
Analgesic trials pose unique scientific, ethical, and practical challenges in pediatrics. Participants in a scientific workshop sponsored by the US Food and Drug Administration developed consensus on aspects of pediatric analgesic clinical trial design. The standard parallel-placebo analgesic trial design commonly used for adults has ethical and practical difficulties in pediatrics, due to the likelihood of subjects experiencing pain for extended periods of time. Immediate-rescue designs using opioid-sparing, rather than pain scores, as a primary outcome measure have been successfully used in pediatric analgesic efficacy trials. These designs maintain some of the scientific benefits of blinding, with some ethical and practical advantages over traditional designs. Preferred outcome measures were recommended for each age group. Acute pain trials are feasible for children undergoing surgery. Pharmacodynamic responses to opioids, local anesthetics, acetaminophen, and nonsteroidal antiinflammatory drugs appear substantially mature by age 2 years. There is currently no clear evidence for analgesic efficacy of acetaminophen or nonsteroidal antiinflammatory drugs in neonates or infants younger than 3 months of age. Small sample designs, including cross-over trials and N of 1 trials, for particular pediatric chronic pain conditions and for studies of pain and irritability in pediatric palliative care should be considered. Pediatric analgesic trials can be improved by using innovative study designs and outcome measures specific for children. Multicenter consortia will help to facilitate adequately powered pediatric analgesic trials.
Indexed as
Identifiers
What OpenQuestion holds
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.