Trial · NCT02571491
Comparison of the Efficacy of Ketamine in Pediatric Patients With Idiopathic Scoliosis After Surgery
NCT02571491, Phase 2, Completed, Fundació Sant Joan de Déu
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of the Efficacy of Ketamine in Pediatric Patients With Idiopathic Scoliosis After Surgery. Trials, record NCT02571491. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02571491
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of the Efficacy of Ketamine in Pediatric Patients With Idiopathic Scoliosis After Surgery
- NCT number
- NCT02571491
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Fundació Sant Joan de Déu
- Conditions
- Progressive Infantile Idiopathic Scoliosis
- Interventions
- Ketamine Hydrochloride, Placebo, Remifentanil, Morphine hydrochloride
- First posted
- 2015-10-08
- Last updated
- 2015-10-08
- Other registries' IDs
- eudract:2011-000407-41
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Consumption of Epidural Morphine at 72h Postoperatively | 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 |
| Secondary | Change From Baseline in Pain Scores (Visual Analogue Scale) | in the first 72 hours after surgery. | 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 |
| Secondary | Rates of significant adverse events | every 4 hours from the begin until the end of the surgical operation | To assess the tolerability of the association of ketamine and opiates |
| Secondary | Time to oral tolerability | up to 6 months from the end of the surgical operation | To assess the efficacy of the association of ketamine and opiates, measuring the time needed from the surgery for reaching the oral tolerability |
| Secondary | Time to First Postoperative Ambulation | up to 6 months from the end of the surgical operation | 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 |
| Secondary | Time to postoperative recovery | up to 6 months from the end of the surgical operation | Post operation period needed for each patient from the end of the surgery until hospital discharge by counting each patient postoperative hospital night admissions |
| Secondary | Change From Baseline in Pain by sensorial test using the Voy Frey filament | in the first 72 hours post surgery | 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. |
| Secondary | Change From Baseline in Pain Scores (Visual Analogue Scale) | at week 6 and after 3 and 6 months post surgery. | Assessment of pain at week 6 and chronic pain after 3 and 6 months post-surgery using the Visual Analogue Scale pain scale |
| Secondary | Change From Baseline in neuropathic pain using Douleur Neuropathique en 4 Questions (DN4) questionnaire | at week 6 and after 3 and 6 months post surgery. | 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 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02571491
GET https://conductscience.org/api/trials/v1/NCT02571491/registered