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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01275547 |
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Date of registration:
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11/01/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Analgesic Effect of Combined Treatment With Intranasal S-ketamine and Intranasal Midazolam
NASKEMI |
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Scientific title:
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The Analgesic Effect of Combined Treatment With Intranasal S-Ketamine and Intranasal Midazolam Compared With Morphine Patient Controlled Analgesia in Spinal Surgery Patients |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01275547 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Wilhelm Ruppen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Basel, Switzerland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Spinal surgery patients with:
- decompression because of spinal stenosis
- laminectomy because of spinal stenosis
- Age > 18 years
- BMI 18 - 39.9 (kg/m2)
Exclusion Criteria:
- Patients unable to give written informed consent
- Known drug allergies or intolerance to the study medications morphine,
midazolam, ketamine, paracetamol or metamizol
- Known allergy to crustacea or chitosan
- Patients using snuff at a regularly basis
- Recreational drug addiction or abuse
- Preexisting opioid (tramadol excluded), ketamine or midazolam therapy
- General physical condition = ASA IV
- Serious intranasal or epipharyngeal problems
- Mental / psychiatric disorder
- Pregnancy
- Patients with renal failure (clearance < 30 ml/min)
- Patients with liver failure (MELD score > 25) Investigational Product Morphine
/ S-ketamine / midazolam
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Spinal Stenosis
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Analgesia, Patient-controlled
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Intervention(s)
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Drug: Morphine PCA
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Drug: s-ketamine & midazolam
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Primary Outcome(s)
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Numeric rating scale 24 hours after surgery
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Amount of PCA boli
[Time Frame: 72 hours]
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Secondary ID(s)
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EKBB28/10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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