Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06184958 |
| Other study ID # |
FMASUR332/2023 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
September 2, 2023 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to assess the efficacy of intravenous lidocaine versus intravenous
ketamine in treatment of fibromyalgia patients.
Description:
Adult fibromyalgia patients (25 to 50 years old) suffering from with uncontrolled pain
perception will be enrolled although maximum medical treatment is prescribed.
Pre-procedure study tools:
- patients are on regular medical treatment in the form of Cymbalta 60 mg/day, Triptyzol
25 mg/day, and Gabapantin 100 mg/day.
- The following will be done for all the patients:
1. Full medical history.
2. Thorough clinical examination.
3. Visual analogue scale for pain assessment pre and post administration of the study
medications.
4. FM impact Questionnaire (FIQR) for assessment quality of life pre and post
administration of the study medications.
5. ECG.
6. Laboratory Investigations will include:
Complete blood count (CBC) Erythrocyte sedimentation rate (ESR) with Westergren blot method
in (mm) after 1st hour (mm/1st hour).
C-reactive protein (CRP) in (mg/dl) by latex method. Kidney function tests. Liver enzymes.
Rheumatoid factor (RF). Anti-nuclear antibody titer (ANA) by indirect immunofluorescence
(IIF).
Patients' recruitment, randomization and control of potential bias The sealed, opaque,
sequentially-numbered envelopes method for randomization and allocation concealment will
used. Identical, opaque, letter-sized envelopes; each containing a white allocation paper
(Marked as "Treatment A") will used and a sheet of single-sided carbon paper closest to the
front of the envelope (with the carbon side facing the white paper). Finally, the envelopes
will be sealed, with signing across the seal. Likewise, another 2 sets will be prepared 25
"Treatment B" envelopes and "Treatment C" envelopes. The three sets (envelopes) will be
combined and shuffled thoroughly. Using a pen, marking a number will be done on the front of
each envelope sequentially from 1 to 75. Then, will place these envelopes into a plastic
container, in numerical order, ready for use.
An investigator (not involved in sequence generation and allocation concealment) will assess
patients for eligibility and assigned eligible patients to either lidocaine intravenous
infusion (Group A) , ketamine infusion (Group B) or placebo infusion (group C). Participants,
care providers, outcomes assessors, and data analysts will be ignorant of the treatment
allocation.
All patients will have an intravenous access with a 20G cannula and will be monitored by
pulse oximetry, electrocardiogram and non-invasive blood measurement (every 5 minutes). They
will be randomly assigned into one of the following three groups:
GROUP A: ( 25 patients) will receive 5 mg/Kg lidocaine in 100 ml normal saline given in 40
minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be
repeated weekly for 3 weeks.
GROUP B: ( 25 patients) will receive 0.5 mg/Kg ketamine sulphate in 100 ml normal saline
given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This
procedure will be repeated weekly for 3 weeks.
Group C: ( 25 patients) will receive placebo 100 ml normal saline given in 40 minutes with 20
minutes follow up to obverse any delayed complication. This procedure will be repeated weekly
for 3 weeks.
All patients will be monitored to detect any abnormalities either due to hypersensitivity of
the patients or due to potential side effects of lidocaine such as dizziness, fatigue,
headache, itchy, warm or red skin, or due to ketamine example hallucination (aborted by 1 mg
midazolam), nausea or vomiting, panic attack or memory problems.
