Sumatriptan and Ondansetron in Treatment of Spinal anesthesia-Induced Pruritus

Phase 1

Recruiting

Conditions: Intrathecal fentanyl-induced pruritus.
Other pruritus

Registration Number: IRCT2017030432871N1

Lead Sponsor: Brain and Spinal Cord Injury Research Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 75

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

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Itch intensity. Timepoint: 0, 5, 10, 20, 30, 60 and 90 minutes after the intervention. Method of measurement: VAS score and DPS score.

Secondary Outcome Measures

Name	Time	Method
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.