Spinal Stenosis Clinical Trial
Official title:
The Analgesic Effect of Combined Treatment With Intranasal S-Ketamine and Intranasal Midazolam Compared With Morphine Patient Controlled Analgesia in Spinal Surgery Patients
Introduction
Ketamine is an old and generally well accepted analgesic used in the intra- and
perioperative setting. Several studies demonstrated the effectiveness of ketamine in the
postoperative setting.
A new formulation of S-ketamine as an intranasal spray device was tested in our hospital in
8 healthy volunteers (unpublished data, EKBB 351/08). 20 mg of S-ketamine were administered
intranasally and compared with S-ketamine i.v. and i.m.. None of the volunteers had serious
adverse effects or complications. A preliminary data analysis shows a clear analgesic effect
and good absorption of the intranasal S-ketamine.
As a next step we would like to investigate the effect of S-ketamine intranasal spray
combined with midazolam intranasal spray in a group of postoperative spinal surgery
patients. The rational for the combination of intranasal S-ketamine and midazolam is the
well known midazolam antagonising effect of ketamine induced psychomimetic adverse effects.
Furthermore we know from other studies (EKBB 106/06) that midazolam intranasal spray has
relaxant and anxiolytic effects. As far as we know, this is the first study which will
examine the combination of S-ketamine and midazolam intranasal sprays in adult patients.
Study work plan
This prospective, randomized, double-blinded non inferiority study will address pain ratings
and patient satisfaction in a postoperative setting in two treatment scenarios:
1. Alternating S-ketamine intranasal unit-dose spray (6 mg per dose) with midazolam
intranasal spray (0.75 mg per dose) patient controlled application with a lock-out
interval of 20 minutes between two applications and placebo patient controlled
analgesia (PCA) with a lock-out interval of 12 minutes with saline 0.9% i.v. for 72
hours or until 40 unit-dose sprays are delivered
2. PCA with 2 mg morphine with a lock-out interval of 12 minutes i.v. with placebo
intranasal spray (saline 0.9% + chitosan) with a minimum lock-out interval of 20
minutes for 72 hours or until 40 unit-dose sprays are delivered
Patient number
We will examine 36 patients, 18 patients in each group. The study duration for an individual
patient will be at latest 72 hours, the total study duration is 4 to 5 months.
Study importance
An intranasal spray is an ideal application form for surgery patients, either in- or
outpatients. On the other hand, ketamine and S-ketamine is quite often used in the
perioperative setting as a rescue analgesic. In higher doses it could be used as an
emergency tool in emergency prehospital medicine. In the perioperative setting it is
important to evaluate the efficacy and safety of S-ketamine intranasal spray combined with
midazolam intranasal spray in patients.
If our study shows that S-ketamine intranasal spray is effective as an analgesic and has
good patient acceptance, S-ketamine intranasal spay could be considered as an alternative,
completely non-invasive analgesic procedure in a postoperative outpatient setting. As a
consequence development of a nasal multidose-applicator combining S-ketamine and midazolam
would be of interest.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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