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ACTIVE NOT RECRUITING
NCT01140724

Personalizing Perioperative Analgesia in Children

Sponsor: Senthil Sadhasivam

View on ClinicalTrials.gov

Summary

In the United States alone, each year approximately 5 million children undergo painful surgery, many of them experience serious side-effects with opioids and inadequate pain relief. Safe and effective analgesia is an important unmet critical medical need in children and its continued existence is an important perioperative safety and economic problem. Inadequate pain relief and serious side effects from perioperative opioids occur frequently in up to 50% of children. Morphine, the most commonly used perioperative opioid, has a narrow therapeutic index and large inter-patient variations in analgesic response and serious side effects. Frequent inter-individual variations in responses to morphine have significant clinical and economic impact with inadequate pain relief at one end of the spectrum of responses and serious adverse effects such as respiratory depression at the other end. Much of the inter-individual variability in response to a dose of morphine following surgical procedures can be explained by single nucleotide polymorphisms (SNPs) in a subset of the genes that encode proteins involved in pain mechanisms and opioid pathway.

Official title: Predicting Perioperative Opioid Adverse Effects and Personalizing Analgesia in Children

Key Details

Gender

All

Age Range

3 Years - 15 Years

Study Type

OBSERVATIONAL

Enrollment

1200

Start Date

2022-02-07

Completion Date

2026-12-25

Last Updated

2026-02-02

Healthy Volunteers

No

Locations (1)

UPMC Children's Hospital

Pittsburgh, Pennsylvania, United States