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
Comparison of the Efficacy of Ketamine in Pediatric Patients With Idiopathic Scoliosis After Surgery
Brief Summary
Comparison of the Efficacy of ketamine measuring the total consumption of morphine in pediatric patients with idiopathic scoliosis
Intervention / Treatment
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Ketamine Hydrochloride (DRUG)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.
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Placebo (OTHER)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
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Remifentanil (DRUG)at doses of 0.3 mcg / kg / min during and until the end of the surgical operation
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Morphine hydrochloride (DRUG)at the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion
Condition or Disease
- Progressive Infantile Idiopathic Scoliosis
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 8 Years to 18 Years |
| Enrollment: | 48 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingTRIPLE:
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Clinical Trial Dates
| Start date: | Jan 01, 2012 | |
|---|---|---|
| Primary Completion: | Feb 01, 2014 | ACTUAL |
| Completion Date: | Feb 01, 2014 | ACTUAL |
| Study First Posted: | Oct 08, 2015 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Oct 07, 2015 |
Sponsors / Collaborators
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.
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.
Participant Groups
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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.
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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.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 8 |
| Maximum Age: | 18 |
| Age Groups: | Child / Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
1. Patients of both genders diagnosed with idiopathic scoliosis aged between 8 and 18 years old.
2. Patients of both genders diagnosed with idiopathic scoliosis and candidates for vertebral fusion corrective surgery with instrumentation.
3. Patients with ASA 1 or ASA 2.
4. Patients and/or parents/tutors consent to participate in the clinical trial.
Exclusion Criteria:
1. Patients with chronic preoperative pain.
2. Patients with addiction to narcotics.
3. Patients with a history of allergy, contraindication or intolerance to the drugs used.
4. Patients unable to understand the patient-controlled analgesia system.
5. Patients with mental disorders.
6. Reoperated patients.
7. Patients requiring elective postoperative ventilation.
8. Pregnant patients.
1. Patients of both genders diagnosed with idiopathic scoliosis aged between 8 and 18 years old.
2. Patients of both genders diagnosed with idiopathic scoliosis and candidates for vertebral fusion corrective surgery with instrumentation.
3. Patients with ASA 1 or ASA 2.
4. Patients and/or parents/tutors consent to participate in the clinical trial.
Exclusion Criteria:
1. Patients with chronic preoperative pain.
2. Patients with addiction to narcotics.
3. Patients with a history of allergy, contraindication or intolerance to the drugs used.
4. Patients unable to understand the patient-controlled analgesia system.
5. Patients with mental disorders.
6. Reoperated patients.
7. Patients requiring elective postoperative ventilation.
8. Pregnant patients.
Primary Outcomes
Secondary Outcomes
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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
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To assess the tolerability of the association of ketamine and opiates
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To assess the efficacy of the association of ketamine and opiates, measuring the time needed from the surgery for reaching the oral tolerability
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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
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Post operation period needed for each patient from the end of the surgery until hospital discharge by counting each patient postoperative hospital night admissions
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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.
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Assessment of pain at week 6 and chronic pain after 3 and 6 months post-surgery using the Visual Analogue Scale pain scale
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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
More Details
| NCT Number: | NCT02571491 |
|---|---|
| Other IDs: | FSJD-ESCOKETA-2010 |
| Study URL: | https://clinicaltrials.gov/study/NCT02571491 |
Last updated: Sep 29, 2023