Personalizing Perioperative Analgesia in Children (NCT01140724) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Personalizing Perioperative Analgesia in Children
United States1,200 participantsStarted 2022-02-07
Plain-language 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.
Who can participate
Age range
3 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: After tonsillectomy surgery (duration of post anesthesia care unit stay)