Personalizing Perioperative Analgesia in Children
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 6 - 15 |
| Updated: | 1/18/2019 |
| Start Date: | April 2008 |
| End Date: | April 2019 |
Predicting Perioperative Opioid Adverse Effects and Personalizing 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.
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.
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 (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.
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.
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 (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.
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.
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
- 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
We found this trial at
2
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Senthilkumar Sadhasivam, MD, MPH
Phone: 513-636-4408
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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