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Active, Not Recruiting

NCT Number: NCT01140724

Personalizing Perioperative Analgesia in Children

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Children's Hospital

Pittsburgh, Pennsylvania, 15224, United States

About this study

Measures and Procedures: Participants will receive standard care, standard anesthetic and an intraoperative dose of morphine per the clinical team.

Research procedures will include:

  • Blood draws for genotyping candidate genes and exploratory genes
  • Standardized PACU (post anesthesia care unit) Protocol: Subjective pain assessments: Numerical Rating Scale (NRS) 0 to 10. Objective assessment with FLACC (facial expression; leg movement; activity; cry; and consolability) scale, 0-10.
  • Significant postoperative pain will be managed in the PACU with rescue doses of morphine and opioids by the clinical team. Analgesic interventions and morphine requirements are collected
  • Effects of opioids on pupil measures
  • Respiratory response to 5% carbon dioxide preoperatively and postoperatively (first 350 patients only). Another measure of end tidal carbon dioxide will be implemented when the device is clinically available.
  • Serial blood draws for morphine pharmacokinetic modeling (through subject #351).
  • Opioid adverse effects in PACU and at home.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • boys and girls,
  • 3-15 years of age,
  • all races,
  • American Society of Anesthesiologists (ASA) physical status 1,2, and 3,
  • children with history of significant snoring suggestive of obstructive sleep apnea (OSA),
  • Scheduled for tonsillectomy (T) or tonsillectomy and adenoidectomy (T and A).

Exclusion criteria

  • allergic to study medications
  • developmental delay,
  • liver and renal diseases,
  • preoperative pain requiring analgesics,
  • children who have problems with pupil or pupillary reaction due to disease
  • preoperative medications influencing pupillary size
  • non-English speaking participants and families
  • Body Mass Index ≥30
  • Participants undergoing additional procedures during surgery
  • Children with certain cardiac conditions
  • Children with severe lung disease
  • Children with a history of seizures currently treated on medication
  • Children with psychiatric/psychological conditions for which patient currently takes medication

Treatment and study plan

Primary outcomes

  1. Look at polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to see if there is a higher susceptibility to pain and morphine requirement.

    Time frame: After tonsillectomy surgery (duration of post anesthesia care unit stay)

    Look at polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to see if there is a relationship to more pain and need for a higher morphine requirement.

Secondary outcomes

  1. Evaluate relationship of pupil reaction and response to 5% carbon dioxide to adverse effects of morphine

    Time frame: After tonsillectomy surgery (duration of post anesthesia care unit stay)

Other outcomes

  1. Evaluate contribution of polymorphisms in genes to variability in codeine response in children with CYP2D6 genotypes predictive of extensive metabolizer or ultra-extensive metabolizer phenotypes

    Time frame: During tonsilectomies

    Evaluate contribution of polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to variability in codeine response in children with CYP2D6 genotypes predictive of extensive metabolizer or ultra-extensive metabolizer phenotypes

  2. Evaluate whether machine learning techniques can be used to predict pain response, opioid responses and morphine usage requirements in patients

    Time frame: After tonsilectomy surgery data collection

    Evaluate whether machine learning techniques can be used to predict pain response, opioid responses and morphine usage requirements in patients solely using information extracted from the medical record as well as in combination with other genetic information

Sponsors and collaborators

Lead sponsor

Senthil Sadhasivam

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Predicting Perioperative Opioid Adverse Effects and Personalizing Analgesia in Children

Important dates

Study start
2022
Primary completion
2022
Study completion
2026
First posted
Jun 9, 2010
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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