Comparison of the Efficacy of Ketamine in Pediatric Patients With Idiopathic Scoliosis After Surgery

NCT ID: NCT02571491

Last Updated: 2015-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-02-28

Brief Summary

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.

Conditions

Progressive Infantile Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ketamine Hydrochloride

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.

Group Type: EXPERIMENTAL

Ketamine Hydrochloride

Intervention Type: 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.

Remifentanil

Intervention Type: DRUG

at doses of 0.3 mcg / kg / min during and until the end of the surgical operation

Morphine hydrochloride

Intervention Type: DRUG

at the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Remifentanil

Intervention Type: DRUG

at doses of 0.3 mcg / kg / min during and until the end of the surgical operation

Morphine hydrochloride

Intervention Type: DRUG

at the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion

Interventions

Ketamine Hydrochloride

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Remifentanil

at doses of 0.3 mcg / kg / min during and until the end of the surgical operation

Intervention Type: DRUG

Morphine hydrochloride

at the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion

Intervention Type: DRUG

Other Intervention Names

KETOLAR 50 mg/ml; 0,9 % physiological serum

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Fundació Sant Joan de Déu

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Perelló Riera, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sant Joan de Déu Servicio de Anestesiología, Reanimación y Tratamiento del Dolor

Locations

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 12467992 (View on PubMed)

Woolf 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.

Reference Type: BACKGROUND

PMID: 10846153 (View on PubMed)

Angst 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.

Reference Type: BACKGROUND

PMID: 14581110 (View on PubMed)

Schmid 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.

Reference Type: BACKGROUND

PMID: 10467917 (View on PubMed)

Other Identifiers

2011-000407-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FSJD-ESCOKETA-2010

Identifier Type: -

Identifier Source: org_study_id