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

Progressive Infantile Idiopathic Scoliosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571491
• Other study ID #: FSJD-ESCOKETA-2010
• Secondary ID: 2011-000407-41
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2015
• Last updated: October 7, 2015
• Start date: January 2012
• Est. completion date: February 2014

Study information

• Verified date: October 2015
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of the Efficacy of ketamine measuring the total consumption of morphine in pediatric patients with idiopathic scoliosis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Progressive Infantile Idiopathic Scoliosis
• Scoliosis

Intervention

Drug:
• 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.

Other:
• 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

Drug:
• Remifentanil
at doses of 0.3 mcg / kg / min during and until the end of the surgical operation
• Morphine hydrochloride
at the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

Mao J. Opioid-induced abnormal pain sensitivity: implications in clinical opioid therapy. Pain. 2002 Dec;100(3):213-7. Review. — View Citation

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):111-25. Review. — View Citation

Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	in the first 72 hours postoperatively
Secondary	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	in the first 72 hours after surgery.
Secondary	Rates of significant adverse events	To assess the tolerability of the association of ketamine and opiates	every 4 hours from the begin until the end of the surgical operation
Secondary	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	up to 6 months from the end of the surgical operation
Secondary	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	up to 6 months from the end of the surgical operation
Secondary	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	up to 6 months from the end of the surgical operation
Secondary	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.	in the first 72 hours post surgery
Secondary	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	at week 6 and after 3 and 6 months post surgery.
Secondary	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	at week 6 and after 3 and 6 months post surgery.