Progressive Infantile Idiopathic ScoliosisPhase 2NCT02571491
Comparison of the Efficacy of Ketamine in Pediatric Patients With Idiopathic Scoliosis After Surgery
A Phase 2 study testing Ketamine Hydrochloride, Remifentanil and Morphine hydrochloride in people with Progressive Infantile Idiopathic Scoliosis, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
Comparison of the Efficacy of ketamine measuring the total consumption of morphine in pediatric patients with idiopathic scoliosis Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Progressive Infantile Idiopathic Scoliosis
- What is being tested?
- Ketamine Hydrochloride, Remifentanil and Morphine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Feb 2014
- Phase
- Phase 2
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of both genders diagnosed with idiopathic scoliosis aged between 8 and 18 years old.
- Patients of both genders diagnosed with idiopathic scoliosis and candidates for vertebral fusion corrective surgery with instrumentation.
- Patients with ASA 1 or ASA 2.
- Patients and/or parents/tutors consent to participate in the clinical trial.
Who cannot join
- Patients with chronic preoperative pain.
- Patients with addiction to narcotics.
- Patients with a history of allergy, contraindication or intolerance to the drugs used.
- Patients unable to understand the patient-controlled analgesia system.
- Patients with mental disorders.
- Reoperated patients.
- Patients requiring elective postoperative ventilation.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Analgesic Efficacy and Tolerability of the Perioperative Association of the Ketamine With Opiates After Posterior Vertebral Fusion Surgery in Children With Idiopathic Scoliosis
Comparison of the Efficacy of ketamine measuring the total consumption of morphine in pediatric patients with idiopathic scoliosis
Read the detailed description
A randomized unicenter clinical trial, parallel, double-blind study, placebo-controlled group.
Involve the participation of Pediatric patients, aged between 11 and 18 years, of both genders, diagnosed with idiopathic scoliosis and posterior spinal fusion surgery candidates included in the Anesthesia Physical Classification System (ASA) 1 or 2 classes.
Both groups received remifentanil at doses of 0.3 mcg / Kg / min before surgical procedure and a bolus of 150 mcg / Kg of morphine hydrochloride, approximately 60 minutes before extubation, followed by PCA morphine hydrochloride administration.
The patients in the experimental group are treated with a combination of ketamine, remifentanil hydrochloride and morphine while the control group will be treated with a combination of saline, remifentanil and morphine hydrochloride.
Treatment of patients in the study is initiated during the induction of anesthesia and ends at the hospital discharge.
The total duration of patient participation in the study is 6 months. During treatment the patients being admitted are monitored at regular intervals, at week 6, after the 3rd month and at 6 months post-intervention to assess the incidence of chronic pain.
The entire study duration is approximately 24 months. The hypothesis of the study is that the combination of subanesthetic doses of ketamine to opioid drugs during the perioperative period reduces central sensitization processes, resulting in lower consumption of postoperative morphine with fewer adverse effects, postoperative faster recovery and less incidence of chronic pain.
The post-operative analgesia is induced by the use of opioids or other analgesics associated with loco-regional techniques. The technique used in the investigators' center is the patient-controlled analgesia (PCA) with the administration of intravenous opioids.
The association of ketamine to opioid treatment could reduce the consumption of these and can be useful in surgery. No clinical trials have been conducted in children with scoliosis, who underwent posterior lumbar fusion surgical procedure, evaluating the efficacy of post-operative association of ketamine to opioid drugs for both intra and post-operative periods.
- Being tested
- Ketamine Hydrochloride, Placebo, Remifentanil, Morphine hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Also called KETOLAR 50 mg/ml
50 mg/ml, IV (in the vein) during surgery operation, followed by IV ketamine hydrocloride perfusion 2mcg/Kg/min before and until 72 hours after operation Number of Cycles: until progression or unacceptable toxicity develops.
PlaceboOther
Also called 0,9 % physiological serum
50 mg/ml, IV (in the vein) during surgery operation, followed by IV placebo perfusion 2mcg/Kg/min before and until 72 hours after operation
RemifentanilDrug
at doses of 0.3 mcg / kg / min during and until the end of the surgical operation
Morphine hydrochlorideDrug
at the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Hydrochloride | Experimental | Received a combination of ketamine, remifentanil and morphine hydrochloride established by the following dosage regimen:
* KETAMINE HYDROCHLORIDE 0,5mg/Kg Intravenous bolus administered during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation
* during surgery remifentanil 0,3 mcg / kg / min.
* at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively. Receives: Drug: Ketamine Hydrochloride; Drug: Remifentanil; Drug: Morphine hydrochloride |
| Placebo | Placebo comparator | Received a combination of physiological serum, remifentanil and morphine hydrochloride established by the following dosage regimen:
* 0,9 % physiological serum 0,5mg/Kg administered by an intravenous (IV) line during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation
* during surgery remifentanil 0.3 mcg / kg / min.
* at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively. Receives: Other: Placebo; Drug: Remifentanil; Drug: Morphine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Consumption of Epidural Morphine at 72h Postoperatively
For the assessment of the related ketamine analgesic efficacy. Cumulative consumption of epidural morphine administered as loading dose, intraoperatively, of 0,3 mcg/kg/min until the surgery operation and 150mcg/Kg of Morphine hydrochloride 60min before extubation
Measured: in the first 72 hours postoperatively
Secondary outcomes (8)
Change From Baseline in Pain Scores (Visual Analogue Scale)
Pain scores at rest and on cough using a 10cm Visual Analogue Scale(0=no pain, 10=worst possible pain for the analgesic efficacy assessment of the association of Ketamine and opiates
Measured: in the first 72 hours after surgery.
Rates of significant adverse events
To assess the tolerability of the association of ketamine and opiates
Measured: every 4 hours from the begin until the end of the surgical operation
Time to oral tolerability
To assess the efficacy of the association of ketamine and opiates, measuring the time needed from the surgery for reaching the oral tolerability
Measured: up to 6 months from the end of the surgical operation
Time to First Postoperative Ambulation
To assess the efficacy of the association of ketamine and opiates, measuring the time needed to being able to walk without assistance within the room or outside the room
Measured: up to 6 months from the end of the surgical operation
Time to postoperative recovery
Post operation period needed for each patient from the end of the surgery until hospital discharge by counting each patient postoperative hospital night admissions
Measured: up to 6 months from the end of the surgical operation
Change From Baseline in Pain by sensorial test using the Voy Frey filament
measure of the area of hyperalgesia of the inflamed skin and the length of the incision after 72 post surgery. The filaments is used to provide a range of forces to the skin of a test subject, in order to find the force at which the subject reacts because the sensation is painful.
Measured: in the first 72 hours post surgery
Change From Baseline in Pain Scores (Visual Analogue Scale)
Assessment of pain at week 6 and chronic pain after 3 and 6 months post-surgery using the Visual Analogue Scale pain scale
Measured: at week 6 and after 3 and 6 months post surgery.
Change From Baseline in neuropathic pain using Douleur Neuropathique en 4 Questions (DN4) questionnaire
The (DN4) questionnaire is a screening tool for neuropathic pain consisting of interview questions (DN4-interview) and physical tests. Two questions (I and II) were based on the interview of the patient and two questions (III and IV) were based on a standardized clinical examination
Measured: at week 6 and after 3 and 6 months post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Progressive Infantile 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Marina Perelló Riera, MD, Principal investigator, Hospital Sant Joan de Déu Servicio de Anestesiología, Reanimación y Tratamiento del Dolor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571491
- Sponsor's protocol ID
- FSJD-ESCOKETA-2010
- Other IDs
- 2011-000407-41
- Status last verified
- Oct 2015
- First submitted
- 28 Sep 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mao J. Opioid-induced abnormal pain sensitivity: implications in clinical opioid therapy. Pain. 2002 Dec;100(3):213-217. doi: 10.1016/S0304-3959(02)00422-0. No abstract available.
PubMed 12467992Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. doi: 10.1126/science.288.5472.1765.
PubMed 10846153Angst MS, Koppert W, Pahl I, Clark DJ, Schmelz M. Short-term infusion of the mu-opioid agonist remifentanil in humans causes hyperalgesia during withdrawal. Pain. 2003 Nov;106(1-2):49-57. doi: 10.1016/s0304-3959(03)00276-8.
PubMed 14581110Schmid RL, Sandler AN, Katz J. Use and efficacy of low-dose ketamine in the management of acute postoperative pain: a review of current techniques and outcomes. Pain. 1999 Aug;82(2):111-125. doi: 10.1016/S0304-3959(99)00044-5.
PubMed 10467917
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Analgesic Efficacy and Tolerability of the Perioperative Association of the Ketamine With Opiates After Posterior Vertebral Fusion Surgery in Children With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT02571491
- Acronym / sponsor ID
- FSJD-ESCOKETA-2010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 8 Oct 2015 (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.
Comparison of the Efficacy of ketamine measuring the total consumption of morphine in pediatric patients with idiopathic scoliosis
Detailed description
A randomized unicenter clinical trial, parallel, double-blind study, placebo-controlled group.
Involve the participation of Pediatric patients, aged between 11 and 18 years, of both genders, diagnosed with idiopathic scoliosis and posterior spinal fusion surgery candidates included in the Anesthesia Physical Classification System (ASA) 1 or 2 classes.
Both groups received remifentanil at doses of 0.3 mcg / Kg / min before surgical procedure and a bolus of 150 mcg / Kg of morphine hydrochloride, approximately 60 minutes before extubation, followed by PCA morphine hydrochloride administration.
The patients in the experimental group are treated with a combination of ketamine, remifentanil hydrochloride and morphine while the control group will be treated with a combination of saline, remifentanil and morphine hydrochloride.
Treatment of patients in the study is initiated during the induction of anesthesia and ends at the hospital discharge.
The total duration of patient participation in the study is 6 months. During treatment the patients being admitted are monitored at regular intervals, at week 6, after the 3rd month and at 6 months post-intervention to assess the incidence of chronic pain.
The entire study duration is approximately 24 months. The hypothesis of the study is that the combination of subanesthetic doses of ketamine to opioid drugs during the perioperative period reduces central sensitization processes, resulting in lower consumption of postoperative morphine with fewer adverse effects, postoperative faster recovery and less incidence of chronic pain.
The post-operative analgesia is induced by the use of opioids or other analgesics associated with loco-regional techniques. The technique used in the investigators' center is the patient-controlled analgesia (PCA) with the administration of intravenous opioids.
The association of ketamine to opioid treatment could reduce the consumption of these and can be useful in surgery. No clinical trials have been conducted in children with scoliosis, who underwent posterior lumbar fusion surgical procedure, evaluating the efficacy of post-operative association of ketamine to opioid drugs for both intra and post-operative periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Hydrochloride | Experimental | Drug: Ketamine Hydrochloride, Drug: Remifentanil, Drug: Morphine hydrochlorideReceived a combination of ketamine, remifentanil and morphine hydrochloride established by the following dosage regimen: * KETAMINE HYDROCHLORIDE 0,5mg/Kg Intravenous bolus administered during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation * during surgery remifentanil 0,3 mcg / kg / min. * at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively. |
| Placebo | Placebo comparator | Other: Placebo, Drug: Remifentanil, Drug: Morphine hydrochlorideReceived a combination of physiological serum, remifentanil and morphine hydrochloride established by the following dosage regimen: * 0,9 % physiological serum 0,5mg/Kg administered by an intravenous (IV) line during the anesthetic induction, followed by 2 mcg / Kg / min of intravenous infusion during and after surgery until 72 hours postoperation * during surgery remifentanil 0.3 mcg / kg / min. * at the end of the operation morphine hydrochloride150 mcg / kg, PCA infusion postoperatively. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients of both genders diagnosed with idiopathic scoliosis aged between 8 and 18 years old.
- Patients of both genders diagnosed with idiopathic scoliosis and candidates for vertebral fusion corrective surgery with instrumentation.
- Patients with ASA 1 or ASA 2.
- Patients and/or parents/tutors consent to participate in the clinical trial.
Key exclusion criteria (8 listed)
- Patients with chronic preoperative pain.
- Patients with addiction to narcotics.
- Patients with a history of allergy, contraindication or intolerance to the drugs used.
- Patients unable to understand the patient-controlled analgesia system.
- Patients with mental disorders.
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 |
|---|---|---|
| Ketamine HydrochlorideAlso: KETOLAR 50 mg/ml50 mg/ml, IV (in the vein) during surgery operation, followed by IV ketamine hydrocloride perfusion 2mcg/Kg/min before and until 72 hours after operation Number of Cycles: until progression or unacceptable toxicity develops. | Drug | Ketamine Hydrochloride |
| PlaceboAlso: 0,9 % physiological serum50 mg/ml, IV (in the vein) during surgery operation, followed by IV placebo perfusion 2mcg/Kg/min before and until 72 hours after operation | Other | Placebo |
| Remifentanilat doses of 0.3 mcg / kg / min during and until the end of the surgical operation | Drug | Ketamine Hydrochloride, Placebo |
| Morphine hydrochlorideat the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion | Drug | Ketamine Hydrochloride, Placebo |
Primary outcome
Cumulative Consumption of Epidural Morphine at 72h Postoperatively
Time frame: in the first 72 hours postoperatively
For the assessment of the related ketamine analgesic efficacy. Cumulative consumption of epidural morphine administered as loading dose, intraoperatively, of 0,3 mcg/kg/min until the surgery operation and 150mcg/Kg of Morphine hydrochloride 60min before extubation
8 secondary outcomes
Change From Baseline in Pain Scores (Visual Analogue Scale)
Time frame: in the first 72 hours after surgery.
Rates of significant adverse events
Time frame: every 4 hours from the begin until the end of the surgical operation
Time to oral tolerability
Time frame: up to 6 months from the end of the surgical operation
Time to First Postoperative Ambulation
Time frame: up to 6 months from the end of the surgical operation
Time to postoperative recovery
Time frame: up to 6 months from the end of the surgical operation
Change From Baseline in Pain by sensorial test using the Voy Frey filament
Time frame: in the first 72 hours post surgery
Change From Baseline in Pain Scores (Visual Analogue Scale)
Time frame: at week 6 and after 3 and 6 months post surgery.
Change From Baseline in neuropathic pain using Douleur Neuropathique en 4 Questions (DN4) questionnaire
Time frame: at week 6 and after 3 and 6 months post surgery.
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 8 Oct 2015.
- Background: PubMed 12467992Mao J. Opioid-induced abnormal pain sensitivity: implications in clinical opioid therapy. Pain. 2002 Dec;100(3):213-217. doi: 10.1016/S0304-3959(02)00422-0. No abstract available.
- Background: PubMed 10846153Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. doi: 10.1126/science.288.5472.1765.
- Background: PubMed 14581110Angst MS, Koppert W, Pahl I, Clark DJ, Schmelz M. Short-term infusion of the mu-opioid agonist remifentanil in humans causes hyperalgesia during withdrawal. Pain. 2003 Nov;106(1-2):49-57. doi: 10.1016/s0304-3959(03)00276-8.
- Background: PubMed 10467917Schmid RL, Sandler AN, Katz J. Use and efficacy of low-dose ketamine in the management of acute postoperative pain: a review of current techniques and outcomes. Pain. 1999 Aug;82(2):111-125. doi: 10.1016/S0304-3959(99)00044-5.
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.
Marina Perelló Riera, MD principal investigator
Hospital Sant Joan de Déu Servicio de Anestesiología, Reanimación y Tratamiento del Dolor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine Hydrochloride, Remifentanil and Morphine hydrochloride in people with Progressive Infantile Idiopathic Scoliosis, run by Fundació Sant Joan de Déu at 1 site in Spain.
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 8 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 8 Oct 2015. 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 Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cumulative Consumption of Epidural Morphine at 72h Postoperatively (time frame: in the first 72 hours postoperatively). 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 NCT02571491, which also lists 4 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 8 Oct 2015.