This interventional trial (n=23 actual) randomised sequential study tests IV S-ketamine (0.2 mg/kg and 0.4 mg/kg) versus an active comparator (clonidine + magnesium) for fibromyalgia.
Randomized, sequential interventional study in patients with fibromyalgia evaluating supportive-care use of intravenous S-ketamine at 0.2 mg/kg and 0.4 mg/kg compared with an active comparator (clonidine 1 µg/kg plus magnesium sulfate 40 mg/kg).
Primary objective is supportive care for pain reduction and quality-of-life improvement in fibromyalgia; outcomes include pain measures and clinical safety/tolerability assessments.
S-ketamine 0.2 mg/kg IV plus clonidine+magnesium active comparator per protocol.
S-ketamine 0.2 mg/kg IV infusion.
Clonidine 1 µg/kg + magnesium sulfate 40 mg/kg diluted in 45 ml saline (active comparator).
S-ketamine 0.4 mg/kg IV plus clonidine+magnesium active comparator per protocol.
S-ketamine 0.4 mg/kg IV infusion.
Clonidine 1 µg/kg + magnesium sulfate 40 mg/kg diluted in 45 ml saline (active comparator).
Active comparator: clonidine 1 µg/kg + magnesium sulfate 40 mg/kg in 45 ml saline.
Clonidine 1 µg/kg + magnesium sulfate 40 mg/kg diluted in 45 ml sodium chloride.
No exclusion criteria listed.