Idiopathic ScoliosisPhase 4KPSFNCT01325493
Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia
A Phase 4 study testing Ketamine and Normal Saline in people with Idiopathic Scoliosis and Spondylolisthesis, run by Julia Finkel at 1 site in United States.
Trial summary
The purpose of this study is to: 1. Establish whether ketamine can decrease opioid consumption and modulate the onset of opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years to 18 years, undergoing posterior spinal fusion and instrumentation. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Idiopathic Scoliosis, Spondylolisthesis
- What is being tested?
- Ketamine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The subject is 10 to 18 years of age
- The subject's American Society of Anesthesiologists physical status is ASA 1, 2 or 3 (see appendix I)
- The subject is scheduled for elective posterior spinal fusion and instrumentation.
- The subject's parent/legally authorized guardian has given written informed consent to participate
Who cannot join
- The subject has a history or a family (parent or sibling) history of malignant hyperthermia
- The subject is pregnant or nursing.
- The subject has known significant renal disorders determined by medical history, physical examination or laboratory tests
- The subject has a known or suspected allergy to morphine, remifentanil or ketamine
- The subject is an ASA classification of 4 or greater (See Appendix I)
- The subject is scheduled for a surgical sub-procedure (i.e. anterior spinal fusion)
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- The subject is unable to self-administer morphine using patient-controlled analgesia (PCA) pump
- The subject had a recent opioid exposure (within 1 month of surgery)
- The subject is obese (body mass index >30kg/m2)
- The subject is planned for elective postoperative ventilation
- The subject has a known ocular disease not permitting pupillometric examination
- The subject has used any investigation products in the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Modulation of μ Opioid Receptor Mediated Analgesia, Tolerance and Hyperalgesia in Children and Adolescents
The purpose of this study is to:
- Establish whether ketamine can decrease opioid consumption and modulate the onset of opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years to 18 years, undergoing posterior spinal fusion and instrumentation.
- Conditions
- Idiopathic Scoliosis, Spondylolisthesis
- Being tested
- Ketamine, Normal Saline
- Keywords
- opioid tolerance, hyperalgesia, scoliosis, pupillometry
- Medical subject headings
- Spondylolisthesis, Hyperalgesia, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketanest, Ketaset, and Ketalar
ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
Normal SalineDrug
Also called 0.90% NaCl
Normal saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | Normal Saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h Receives: Drug: Normal Saline |
| Ketamine | Active comparator | ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Equivalent Consumption (mg/kg)
Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.
Measured: at 24, 48, 72, 96 hours post operatively
Secondary outcomes (3)
Sedation Score
Sedation scores 0 = completely awake
- = sleepy but responds appropriately
- = somnolent but arouses to light stimuli
- = asleep but responsive to deeper physical stimuli
- = asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery.
Measured: 24, 48, 72, 96 hours post operatively
Pain Score at Rest
Patient volunteered response at rest, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.
Measured: 24, 48, 72, 96 hours post operatively
Pain Score During Cough.
Patient volunteered response during a cough, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.
Measured: 24, 48, 72, 96 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJan 2010
- Primary completionMay 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic ScoliosisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julia Finkel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julia Finkel, Children's National Research Institute
- Investigators
- Pestieau Sophie, MD, Principal investigator, Children's National Research InstituteFinkel C Julie, MD, Study director, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325493
- Sponsor's protocol ID
- 4735
- Acronym
- KPSF
- Status last verified
- Dec 2015
- First submitted
- 25 Feb 2011
- Last updated
- 14 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pestieau SR, Finkel JC, Junqueira MM, Cheng Y, Lovejoy JF, Wang J, Quezado Z. Prolonged perioperative infusion of low-dose ketamine does not alter opioid use after pediatric scoliosis surgery. Paediatr Anaesth. 2014 Jun;24(6):582-90. doi: 10.1111/pan.12417.
PubMed 24809838
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of μ Opioid Receptor Mediated Analgesia, Tolerance and Hyperalgesia in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01325493
- Acronym / sponsor ID
- KPSF / 4735
- Conditions
- Idiopathic Scoliosis, Spondylolisthesis
- Keywords
- opioid tolerance, hyperalgesia, scoliosis, pupillometry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Julia FinkelUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 2 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to:
- Establish whether ketamine can decrease opioid consumption and modulate the onset of opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years to 18 years, undergoing posterior spinal fusion and instrumentation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: Normal SalineNormal Saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h |
| Ketamine | Active comparator | Drug: Ketamineketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The subject is 10 to 18 years of age
- The subject's American Society of Anesthesiologists physical status is ASA 1, 2 or 3 (see appendix I)
- The subject is scheduled for elective posterior spinal fusion and instrumentation.
- The subject's parent/legally authorized guardian has given written informed consent to participate
Key exclusion criteria (12 listed)
- The subject has a history or a family (parent or sibling) history of malignant hyperthermia
- The subject is pregnant or nursing.
- The subject has known significant renal disorders determined by medical history, physical examination or laboratory tests
- The subject has a known or suspected allergy to morphine, remifentanil or ketamine
- The subject is an ASA classification of 4 or greater (See Appendix I)
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 |
|---|---|---|
| KetamineAlso: Ketanest, Ketaset, and Ketalarketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h | Drug | Ketamine |
| Normal SalineAlso: 0.90% NaClNormal saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h | Drug | Normal Saline |
Primary outcome
Morphine Equivalent Consumption (mg/kg)
Time frame: at 24, 48, 72, 96 hours post operatively
Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.
3 secondary outcomes
Sedation Score
Time frame: 24, 48, 72, 96 hours post operatively
Pain Score at Rest
Time frame: 24, 48, 72, 96 hours post operatively
Pain Score During Cough.
Time frame: 24, 48, 72, 96 hours post operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24809838Pestieau SR, Finkel JC, Junqueira MM, Cheng Y, Lovejoy JF, Wang J, Quezado Z. Prolonged perioperative infusion of low-dose ketamine does not alter opioid use after pediatric scoliosis surgery. Paediatr Anaesth. 2014 Jun;24(6):582-90. doi: 10.1111/pan.12417.
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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.
Pestieau Sophie, MD principal investigator
Children's National Research Institute
Finkel C Julie, MD study director
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Normal Saline in people with Idiopathic Scoliosis and Spondylolisthesis, run by Julia Finkel 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 12 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 14 Jan 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Morphine Equivalent Consumption (mg/kg) (time frame: at 24, 48, 72, 96 hours post operatively). 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 NCT01325493, which also lists 1 linked publication.
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 14 Jan 2016.