Personalizing Perioperative Analgesia in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01140724
First received: June 8, 2010
Last updated: July 21, 2014
Last verified: April 2014
  Purpose

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.


Condition
Postoperative Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Predicting Perioperative Opioid Adverse Effects and Personalizing Analgesia in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Biospecimen Retention:   Samples With DNA

DNA from blood is obtained and analyzed for genetic varaiations


Estimated Enrollment: 700
Study Start Date: April 2008
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Detailed Description:

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

Research procedures will include:

  1. Blood draws for genotyping candidate genes and exploratory genes
  2. Standardized PACU 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.
  3. 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
  4. Effects of opioids on pupil measures
  5. 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.
  6. Serial blood draws for morphine pharmacokinetic modeling (through subject #351).
  7. Opioid adverse effects in PACU and at home.
  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children, 6-15 years of age, undergoing tonsillectomy or adenotonsillectomy at the Cincinati Children's Hospital Medical Center (CCHMC), who have consented to participate in an observational clinical study as approved by the CCHMC IRB, protocol # 2008-0848.

Criteria

Inclusion Criteria:

  • boys and girls,
  • 6-15 years of age,
  • all races,
  • American Society of Anesthesiologists (ASA) physical status 1 and 2,
  • children with history of significant snoring suggestive of obstructive sleep apnea (OSA.)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140724

Contacts
Contact: Senthilkumar Sadhasivam, MD, MPH 5136364408 senthilkumar.sadhasivam@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Senthilkumar Sadhasivam, MD, MPH    513-636-4408    senthilkumar.sadhasivam@cchmc.org   
Contact: Marietta Labbato, BS    5136365983    marietta.labbato@cchmc.org   
Principal Investigator: Senthilkumar Sadhasivam, MD, MPH         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Senthilkumar Sadhasivam, MD, MPH Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided by Children's Hospital Medical Center, Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01140724     History of Changes
Other Study ID Numbers: CCHMC2008-0848
Study First Received: June 8, 2010
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
pain
genes
morphine
respiratory depression
tonsillectomy
children
Opioid adverse effects
Pharmacogenetics of morphine
Pharmacokinetics of morphine
Personalizing analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014