PainNCT01813695

Preemptive Genotyping and Pain Management

An observational study of Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to see if testing for genes related to pain and pain management before surgery affects how patients are treated for pain after surgery. The investigators want to know if this information will be used to effectively treat patients for pain after surgery if the clinical staff have a chance… Read more about this study

Who is it for?: Ages 6 to 21 years
Conditions the study is for: Pain
What is being tested?: Preemptive genotyping in medical record and Genotyping not included in electronic medical record
Type of treatment: Surgery or procedure
How many people: 576 participants
Where: 1 siteUnited States
Study dates: Mar 2013to 30 Dec 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 21 years
All sexes
No healthy volunteers
Child, Adult

Study population: Pediatric patients scheduled for scoliosis and pectus excavatum surgeries.

Who may be able to join

Children, 6-17 years of age and adults, 18 - 21 years with idiopathic scoliosis and/or pectus excavatum scheduled for surgical clinic visit
BMI < 30
Cognitively able to use a 0 - 10 numerical rating scale (NRS) to report level of pain
Parents give permission (and children give assent when appropriate) or adult participants give consent for CYP2D6 results to be placed in Cincinnati Children's Hospital Medical Center (CCHMC's) EPIC

Who cannot join

• Who had prior surgery for idiopathic scoliosis and/or pectus excavatum
Who have prior CYP2D6 testing or Genetic Pharmacology Service (GPS) Psychiatry Panel documented in EPIC
Who are taking prescription medication known to inhibit or induce CYP2D6
Who are taking prescription medication known to inhibit (e.g. voriconazole) or induce (e.g. carbamazepine and rifampin) CYP3A4
Who have liver or renal failure
Who have history of narcotic abuse

Trial locations and contacts

1 site in 1 country.

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Preemptive Genotyping of Children and Adolescents at Risk for Surgery and Subsequent Pain Management

Read the detailed description

Purpose: To determine the feasibility of preemptive (preoperative) cytochrome P450 isoenzyme (CYP2D6) testing and the variability of clinical measures (postoperative) in children whose opioid selection and dosing is influenced by preemptive CYP2D6 testing compared to children whose pain management does not include CYP2D6 preemptive testing. Results from this pilot study will inform a future study investigating the utility of preemptive pharmacogenomic testing in children at risk for requiring inpatient acute pain management with opioids.

Conditions: Pain
Being tested: Preemptive genotyping in medical record, Genotyping not included in electronic medical record
Keywords: Preemptive genetic testing, Pain, Pediatrics, Orthopedics, Pectus excavatum, Scoliosis
Medical subject headings: Pain, Funnel Chest, Scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Preemptive genotyping in medical recordProcedure or surgery
Genotyping not included in electronic medical recordProcedure or surgery

Study groups in NCT01813695
Study group	Role	What they receive
Preemptive		Patients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively. Receives: Procedure: Preemptive genotyping in medical record
Control		Genetic sample taken but withheld from electronic medical record. Receives: Procedure: Genotyping not included in electronic medical record

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of PreEmptive Genotyping Testing
The Investigator will use descriptive and summary statistics to determine the feasibility of preemptive CYP2D6 testing in children evaluated during a clinic visit for potential surgery.
Measured: From initial clinic visit to post-operative discharge, expected average of three months

Secondary outcomes (6)

Analgesia Effectiveness
Pain score (NRS 0 - 10) before and after each oral opioid dose (we will use time between the before and after pain score measures as a covariate)
Measured: Admission for surgery, up to two weeks
Analgesia Toxicity
1. At least 1 documented ADR;
2. Total number of documented ADRs;
3. Total number of ADR related responses in "Pain Medicine Report" answered "sometimes" or "always";
4. Total number of documented GI related ADRs - nausea (yes/no) and vomiting (yes/no);
5. Total number of documented central nervous system (CNS) ADRs (Modified Ramsay scores > 4 and respiratory rate (RR) indicative of respiratory depression; and oxygen saturations (SpO2) < 90% on room air; and need for supplemental oxygen; and response of "always" for "Pain Medicine Report" question, "When you took the pain medicine, how often did it make you fall asleep?"
Measured: Admission for surgery, up to two weeks
Analgesia Effectiveness
Participant related responses in "Pain Medicine Report"
Measured: Admission for surgery, up to two weeks
Analgesia Effectiveness
Total number of rescue IV pain medication doses
Measured: Admission for surgery, up to two weeks
Analgesia Effectiveness
Total number of concomitant analgesic adjunct medications such as muscle relaxants, acetaminophen.
Measured: Admission for surgery, up to two weeks
Analgesia Effectiveness
Total mg/kg 24hr dose of oral opioids
Measured: Admission for surgery, up to two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201330 Dec 2022

First posted19 Mar 2013 (estimated)
Study startMar 2013
Primary completion4 Nov 2020
Study completion30 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (47)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 576 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01813695
Sponsor's protocol ID: 2013-0853
Other IDs: NIH 3U01 HG006828-01S1
Status last verified: Feb 2024
First submitted: 11 Mar 2013
Last updated: 22 Feb 2024
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Sadhasivam S, Boat A, Mahmoud M. Comparison of patient-controlled analgesia with and without dexmedetomidine following spine surgery in children. J Clin Anesth. 2009 Nov;21(7):493-501. doi: 10.1016/j.jclinane.2008.12.017.
PubMed 20006257
Voepel-Lewis T, Marinkovic A, Kostrzewa A, Tait AR, Malviya S. The prevalence of and risk factors for adverse events in children receiving patient-controlled analgesia by proxy or patient-controlled analgesia after surgery. Anesth Analg. 2008 Jul;107(1):70-5. doi: 10.1213/ane.0b013e318172fa9e.
PubMed 18635469
Aubrun F, Monsel S, Langeron O, Coriat P, Riou B. Postoperative titration of intravenous morphine. Eur J Anaesthesiol. 2001 Mar;18(3):159-65. doi: 10.1046/j.0265-0215.2000.00796.x.
PubMed 11298174
Ross JR, Rutter D, Welsh K, Joel SP, Goller K, Wells AU, Du Bois R, Riley J. Clinical response to morphine in cancer patients and genetic variation in candidate genes. Pharmacogenomics J. 2005;5(5):324-36. doi: 10.1038/sj.tpj.6500327.
PubMed 16103897
D'Arcy Y. One opioid does not fit all. Nurse Pract. 2007 Nov;32(11):7-8. doi: 10.1097/01.NPR.0000298262.47655.14. No abstract available.
PubMed 18075450
Sadhasivam S, Cohen LL, Szabova A, Varughese A, Kurth CD, Willging P, Wang Y, Nick TG, Gunter J. Real-time assessment of perioperative behaviors and prediction of perioperative outcomes. Anesth Analg. 2009 Mar;108(3):822-6. doi: 10.1213/ane.0b013e318195c115.
PubMed 19224789
Beaulieu P, Cyrenne L, Mathews S, Villeneuve E, Vischoff D. Patient-controlled analgesia after spinal fusion for idiopathic scoliosis. Int Orthop. 1996;20(5):295-9. doi: 10.1007/s002640050081.
PubMed 8930721
Dahan A, Aarts L, Smith TW. Incidence, Reversal, and Prevention of Opioid-induced Respiratory Depression. Anesthesiology. 2010 Jan;112(1):226-38. doi: 10.1097/ALN.0b013e3181c38c25.
PubMed 20010421
Hanna MH, Elliott KM, Fung M. Randomized, double-blind study of the analgesic efficacy of morphine-6-glucuronide versus morphine sulfate for postoperative pain in major surgery. Anesthesiology. 2005 Apr;102(4):815-21. doi: 10.1097/00000542-200504000-00018.
PubMed 15791112
Duedahl TH, Hansen EH. A qualitative systematic review of morphine treatment in children with postoperative pain. Paediatr Anaesth. 2007 Aug;17(8):756-74. doi: 10.1111/j.1460-9592.2007.02213.x.
PubMed 17596221
Gramke HF, de Rijke JM, van Kleef M, Raps F, Kessels AG, Peters ML, Sommer M, Marcus MA. The prevalence of postoperative pain in a cross-sectional group of patients after day-case surgery in a university hospital. Clin J Pain. 2007 Jul-Aug;23(6):543-8. doi: 10.1097/AJP.0b013e318074c970.
PubMed 17575496
Sommer M, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Geurts JW, Gramke HF, Marcus MA. The prevalence of postoperative pain in a sample of 1490 surgical inpatients. Eur J Anaesthesiol. 2008 Apr;25(4):267-74. doi: 10.1017/S0265021507003031. Epub 2007 Dec 6.
PubMed 18053314
Fletcher D, Fermanian C, Mardaye A, Aegerter P; Pain and regional anesthesia committee of the French Anesthesia and Intensive Care Society (SFAR). A patient-based national survey on postoperative pain management in France reveals significant achievements and persistent challenges. Pain. 2008 Jul 15;137(2):441-451. doi: 10.1016/j.pain.2008.02.026. Epub 2008 Apr 15.
PubMed 18417292
Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55.
PubMed 17578977
Joshi GP, Kehlet H, Rawal N; PROSPECT Working Group. Evidence-based guidelines for postoperative pain management. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):173. doi: 10.1016/j.rapm.2006.11.002. No abstract available.
PubMed 17350537

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preemptive Genotyping of Children and Adolescents at Risk for Surgery and Subsequent Pain Management
ClinicalTrials.gov ID: NCT01813695
Acronym / sponsor ID: 2013-0853
Conditions: Pain
Keywords: Preemptive genetic testing, Pain, Pediatrics, Orthopedics, Pectus excavatum, Scoliosis
Study type: Observational
Recruitment status: Completed
Enrolment: 576 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Study start: Mar 2013
Primary completion: 4 Nov 2020 (actual)
Study completion: 30 Dec 2022 (actual)
First posted: 19 Mar 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Preemptive	–	Procedure: Preemptive genotyping in medical recordPatients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively.
Control	–	Procedure: Genotyping not included in electronic medical recordGenetic sample taken but withheld from electronic medical record.

Who may qualify

Ages: 6 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Pediatric patients scheduled for scoliosis and pectus excavatum surgeries.

Key inclusion criteria (4 listed)

Children, 6-17 years of age and adults, 18 - 21 years with idiopathic scoliosis and/or pectus excavatum scheduled for surgical clinic visit
BMI < 30
Cognitively able to use a 0 - 10 numerical rating scale (NRS) to report level of pain
Parents give permission (and children give assent when appropriate) or adult participants give consent for CYP2D6 results to be placed in Cincinnati Children's Hospital Medical Center (CCHMC's) EPIC

Key exclusion criteria (6 listed)

• Who had prior surgery for idiopathic scoliosis and/or pectus excavatum

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Preemptive genotyping in medical record	Procedure or surgery	Preemptive
Genotyping not included in electronic medical record	Procedure or surgery	Control

Primary outcome

Feasibility of PreEmptive Genotyping Testing
Time frame: From initial clinic visit to post-operative discharge, expected average of three months
The Investigator will use descriptive and summary statistics to determine the feasibility of preemptive CYP2D6 testing in children evaluated during a clinic visit for potential surgery.

6 secondary outcomes

Analgesia Effectiveness
Time frame: Admission for surgery, up to two weeks
Analgesia Toxicity
Time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
Time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
Time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
Time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
Time frame: Admission for surgery, up to two weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
Background: PubMed 20006257Sadhasivam S, Boat A, Mahmoud M. Comparison of patient-controlled analgesia with and without dexmedetomidine following spine surgery in children. J Clin Anesth. 2009 Nov;21(7):493-501. doi: 10.1016/j.jclinane.2008.12.017.
Background: PubMed 18635469Voepel-Lewis T, Marinkovic A, Kostrzewa A, Tait AR, Malviya S. The prevalence of and risk factors for adverse events in children receiving patient-controlled analgesia by proxy or patient-controlled analgesia after surgery. Anesth Analg. 2008 Jul;107(1):70-5. doi: 10.1213/ane.0b013e318172fa9e.
Background: PubMed 11298174Aubrun F, Monsel S, Langeron O, Coriat P, Riou B. Postoperative titration of intravenous morphine. Eur J Anaesthesiol. 2001 Mar;18(3):159-65. doi: 10.1046/j.0265-0215.2000.00796.x.
Background: PubMed 16103897Ross JR, Rutter D, Welsh K, Joel SP, Goller K, Wells AU, Du Bois R, Riley J. Clinical response to morphine in cancer patients and genetic variation in candidate genes. Pharmacogenomics J. 2005;5(5):324-36. doi: 10.1038/sj.tpj.6500327.
Background: PubMed 18075450D'Arcy Y. One opioid does not fit all. Nurse Pract. 2007 Nov;32(11):7-8. doi: 10.1097/01.NPR.0000298262.47655.14. No abstract available.
Background: PubMed 19224789Sadhasivam S, Cohen LL, Szabova A, Varughese A, Kurth CD, Willging P, Wang Y, Nick TG, Gunter J. Real-time assessment of perioperative behaviors and prediction of perioperative outcomes. Anesth Analg. 2009 Mar;108(3):822-6. doi: 10.1213/ane.0b013e318195c115.
Background: PubMed 8930721Beaulieu P, Cyrenne L, Mathews S, Villeneuve E, Vischoff D. Patient-controlled analgesia after spinal fusion for idiopathic scoliosis. Int Orthop. 1996;20(5):295-9. doi: 10.1007/s002640050081.
Background: PubMed 20010421Dahan A, Aarts L, Smith TW. Incidence, Reversal, and Prevention of Opioid-induced Respiratory Depression. Anesthesiology. 2010 Jan;112(1):226-38. doi: 10.1097/ALN.0b013e3181c38c25.
Background: PubMed 15791112Hanna MH, Elliott KM, Fung M. Randomized, double-blind study of the analgesic efficacy of morphine-6-glucuronide versus morphine sulfate for postoperative pain in major surgery. Anesthesiology. 2005 Apr;102(4):815-21. doi: 10.1097/00000542-200504000-00018.
Background: PubMed 17596221Duedahl TH, Hansen EH. A qualitative systematic review of morphine treatment in children with postoperative pain. Paediatr Anaesth. 2007 Aug;17(8):756-74. doi: 10.1111/j.1460-9592.2007.02213.x.
Background: PubMed 17575496Gramke HF, de Rijke JM, van Kleef M, Raps F, Kessels AG, Peters ML, Sommer M, Marcus MA. The prevalence of postoperative pain in a cross-sectional group of patients after day-case surgery in a university hospital. Clin J Pain. 2007 Jul-Aug;23(6):543-8. doi: 10.1097/AJP.0b013e318074c970.
Background: PubMed 18053314Sommer M, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Geurts JW, Gramke HF, Marcus MA. The prevalence of postoperative pain in a sample of 1490 surgical inpatients. Eur J Anaesthesiol. 2008 Apr;25(4):267-74. doi: 10.1017/S0265021507003031. Epub 2007 Dec 6.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Senthilkumar Sadhasivam, MD, MPH principal investigator

Children's Hospital Medical Center, Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of PreEmptive Genotyping Testing (time frame: From initial clinic visit to post-operative discharge, expected average of three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01813695, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.