NCT01481922 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Abouleish E, Mitchell M, Taylor G, Miller H, Warters D, Rashad MN
Comparative flow rates of saline in commonly used spinal needles including pencil-tip needles. Reg Anesth. 1994 Jan-Feb;19(1):34-42.
Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology
Addendum to assessment: Prevention of post-lumbar puncture headaches: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2.
Carson D, Serpell M
Choosing the best needle for diagnostic lumbar puncture. Neurology. 1996 Jul;47(1):33-7.

Should Physicians Use a 24 Gauge Spinal Needle Instead of a 22 Gauge When Performing a Lumbar Puncture ? A Randomized Controlled Trial.

Clinical trial NCT01481922 - References