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Last Updated: December 3, 2022

CLINICAL TRIALS PROFILE FOR MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE


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All Clinical Trials for Midazolam Hydrochloride Preservative Free

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01055236 ↗ Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients Completed Mahidol University Phase 4 2007-08-01 Hydroxyzine is one of antihistamines that antagonizes H1 receptor, and it's effects are reducing pruritus, nausea/vomiting, and the mild effect of sedation.With these effects Hydroxyzine should be used in the prevention of these symptoms.
NCT01236859 ↗ Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus Completed Prince of Songkla University N/A 2009-09-01 Intrathecal morphine provides good postoperative analgesia for up to 18-24 hour after administration. Pruritus is the most common side effect of intrathecal morphine, which the incidence was reported as 20%-100%2 and 63% in Songklanagarind Hospital. Pathophysiology of opioid-induced pruritus remain unclear and more than one mechanism may be involved in the development of opioid-induced pruritus, such as, mediated central ยต opioid receptors, Dopamine (D2) receptors, Serotonin (5-HT3) receptors, prostaglandin system, GABA receptors, and glycine receptors, so that why opioid-induced pruritus is difficult to manage. Many medications have been used to treat this side effect included antihistamines, 5-HT3 (serotonin) receptor antagonists, opioid antagonists, opioid agonist-antagonists, propofol, and nonsteroidal antiinflammatory drugs. Gabapentin is an anticonvulsant, a structural analog of aminobutyric acid, and currently approved by the Food and Drug Administration for the treatment of partial seizures and postherpetic neuralgia. Many studies have shown gabapentin to be effective in the case of brachioradial pruritus, itch of neuropathic in origin, uremic pruritus, multiple sclerosis-induced pruritus,cholestatic pruritus, itch produced by burn, and pruritus of unknown origin. However, there is only one small study in Taiwan shown the effectiveness of gabapentin 1200 mg in prevention of intrathecal morphine-induced pruritus in orthopedic surgery, which could reduce incidence of pruritus from 77.5% to 47.5% (38.7% reduction). Because gabapentin has several side effects especially in high dose such as drowsiness, dry mouth, headache, unsteadiness, reduced co-ordination or slowed reaction, constipation, diarrhea, peripheral edema, dizziness, confusion, loss of concentration, weight gain, and nausea, vomiting, so in our study we decided to reduce the dose of gabapentin. Therefore, we would like to know if gabapentin in a smaller dose (600 mg) used in the wider range of age including the elderly can decrease the incidence of intrathecal morphine-induced pruritus in orthopedic surgery in Songklanagarind Hospital.
NCT01404442 ↗ Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section Completed Qazvin University Of Medical Sciences Phase 1/Phase 2 2011-05-01 Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an additive to bupivacaine in patients undergoing cesarean section . Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation, dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Midazolam Hydrochloride Preservative Free

Condition Name

Condition Name for Midazolam Hydrochloride Preservative Free
Intervention Trials
Pruritus 3
Pain 1
Hip Arthroscopy 1
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Condition MeSH

Condition MeSH for Midazolam Hydrochloride Preservative Free
Intervention Trials
Pruritus 3
Vomiting 2
Nausea 2
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Clinical Trial Locations for Midazolam Hydrochloride Preservative Free

Trials by Country

Trials by Country for Midazolam Hydrochloride Preservative Free
Location Trials
United States 15
Egypt 2
Thailand 2
Iran, Islamic Republic of 1
Brazil 1
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Trials by US State

Trials by US State for Midazolam Hydrochloride Preservative Free
Location Trials
Virginia 2
Pennsylvania 2
Ohio 2
West Virginia 1
Texas 1
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Clinical Trial Progress for Midazolam Hydrochloride Preservative Free

Clinical Trial Phase

Clinical Trial Phase for Midazolam Hydrochloride Preservative Free
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Midazolam Hydrochloride Preservative Free
Clinical Trial Phase Trials
Completed 11
Unknown status 1
Not yet recruiting 1
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Clinical Trial Sponsors for Midazolam Hydrochloride Preservative Free

Sponsor Name

Sponsor Name for Midazolam Hydrochloride Preservative Free
Sponsor Trials
University of Pennsylvania 2
Pacira Pharmaceuticals, Inc 1
Virginia Commonwealth University 1
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Sponsor Type

Sponsor Type for Midazolam Hydrochloride Preservative Free
Sponsor Trials
Other 13
Industry 1
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