Intrathecal fentanyl-induced pruritus. Other pruritus
Conditions
Interventions
Intervention 1: Intervention/Control 1: Sumatriptan 6mg/0.5ml statdose subcutaneous injection + Placebo in volume of 4ml statdose IV injection. Intervention 2: Intervention/Control 2: Placebo in volum
Treatment - Drugs
Placebo
Intervention/Control 1: Sumatriptan 6mg/0.5ml statdose subcutaneous injection + Placebo in volume of 4ml statdose IV injection
Intervention/Control 2: Placebo in volume of 0.5ml statdose subcutaneous injection + Ondansetron 8mg/4ml statdose IV injection
Intervention/Control 3: Placebo in volume of 0.5ml statdose subcutaneous injection + Placebo in volume of 4ml statdose IV injection
Sponsors
Brain and Spinal Cord Injury Research Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Males or females who are at least 18 years and no more than 65 years of age; Candidate for urologic, gynecologic or general surgery with spinal anesthesia, Intrathecal fentanyl-induced pruritus; Giving informed consent; ASA physical status I-II; GCS equal to 15; Exclusion criteria: Pruritus secondary to a pruritic skin disease or systemic disorder; Topical or systemic treatments which may affect the intensity of itch; History of cardiovascular diseases, or uncontrolled serious systemic disorders; Currently is taking a monoamine oxidase inhibitor (MAO) or has taken a MAOI within the 2 weeks prior to screen; Currently is taking an ergotamine-containing medication; Being pregnant, actively trying to become pregnant or breastfeeding; Alcohol or substance abuse
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Itch intensity. Timepoint: 0, 5, 10, 20, 30, 60 and 90 minutes after the intervention. Method of measurement: VAS score and DPS score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity. Timepoint: 15, 30, 60 and 90 minutes after the intervention. Method of measurement: VAS score.;Nausea, vomiting intensity. Timepoint: 15, 30, 60 and 90 minutes after the intervention. Method of measurement: 4-point rating score for nausea and vomiting.;Side effects. Timepoint: 5, 10, 20, 30, 60 and 90 minutes after the intervention. Method of measurement: Occurrence of any type of medical complications from clinical evidence and patient complaints.;Treatment satisfaction. Timepoint: 90 minute after the intervention. Method of measurement: Asking the patients. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAhmad-Reza Dehpour
Experimental Medicine Research Center, Tehran University of Medical Sciences
Outcome results
None listed