An observational study in Scoliosis, Kyphosis and Kyphoscoliosis, sponsored by Children's Hospital Medical Center, Cincinnati. Active, not recruiting at 5 sites in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
This will be an open label, prospective study to determine the association between specific genotypes, epigenetics and behavioral factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic and side effect responses to perioperative opioids, chronic postoperative pain and gene expression in adolescents following major spine surgery.
Safe and effective analgesia is an important unmet medical need in children. Despite efforts to promote non-pharmacologic interventions, drug treatment remains the standard of care for children experiencing severe pain following surgery. Inadequate pain relief after invasive surgery, and side effects from analgesics such as morphine occur frequently in up to 50% of children. A study of patient controlled analgesia (PCA) morphine use after spine surgery in adolescents observed a 45% incidence of postoperative nausea and vomiting and 7% incidence of respiratory depression. Presently, evidence-based dosing guidelines for opioid therapy have not been ascertained in the pediatric patient population, and remains a trial and error method. Despite aggressive pain management after spine surgery, findings showed that neither children's pain nor their analgesic use diminished significantly over time. As such, there is a critical knowledge gap in the medical literature that significantly impacts the pediatric pain management. Moreover, chronic postsurgical pain (CPSP, defined as pain attributable to the surgical procedure lasting for more than 2 months after surgery critically impacts 13-30% of children having surgery, and leads to chronic pain as adults imposing extraordinary annual costs on the health care system ($560-635 billion). It has been recently shown that pain unpleasantness predicts the transition from acute to moderate/severe persistent post-surgical pain, whereas anxiety sensitivity predicts the maintenance of moderate/severe post-surgical pain from 6 to 12 months after surgery. Spine fusion in adolescents is a particularly painful surgery with 15% incidence of pain even 5 years after surgery, and hence will serve as a good surgical model to evaluate the behavioral and genetic predictors of chronic postoperative pain. In recognition of this therapeutic challenge the investigators plan to evaluate the determinants of inter-individual differences in opioid analgesic responsiveness, adverse effects, pain perception and predictors of chronic postoperative pain in children. In addition, pectus procedures are painful and will also be included in the study, alongwith analgesia modalities. Secondary analyses will include analgesic associations with study outcomes.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's planned enrollment of 880 is above the median of 84 across 256 observational studies indexed under Scoliosis.
Browse Scoliosis studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 8, 2026. See what changed
The investigators will recruit a total of 880 subjects over the study period to acquire the data necessary to derive a predictive model matching phenotype to genotype. They will be recruited from the population of children ages 10 and above, inclusive, years scheduled for spinal surgical procedures/Nuss procedures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Numeric rating scale (NRS) pain scores
Time frame: Data will be collected for 48 hours postoperatively
Occurrences of respiratory depression
Respiratory rate (RR) \<10 on POD 1 and 2
Time frame: Data will be collected for 48 hours postoperatively
Occurrences of post-operative nausea/vomiting (PONV)
Time frame: Data will be collected for 48 hours postoperatively
Amount of morphine (or equivalent) used by patient
Time frame: Data will be collected for 48 hours postoperative
Chronic pain postoperatively
Participants will complete questionnaires regarding pain since surgery was completed
Time frame: 2 - 6 months postoperatively
Persistent pain postoperatively
Participants will complete questionnaires regarding pain since surgery was completed
Time frame: 10 - 12 months postoperatively
Opioid addiction by history on follow-up
Time frame: 1 year postoperatively
Plan to share: No
The record gives a start of Dec 2016, a primary completion of Dec 2025 and a completion of Dec 2026. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati →