Study to Evaluate Efficacy and Safety of Sumatriptan and Ondansetron for the Treatment of Intrathecal Fentanyl-Induced Pruritus in Patients Undergoing Spinal Anesthesia
This randomized, double-blind, and placebo-controlled study (phase 1-2) is done at ValiAsr and Imam Khomeini hospitals. The aim of this study is to investigate the efficacy and safety of sumatriptan vs. ondansetron and placebo for the treatment of intrathecal fentanyl-induced pruritus. Participants and investigators are blinded through the study. Participants are chosen among the patients with intrathecal fentanyl-induced pruritus in an elective gynecologic, urologic or general surgery. Seventy-five ASA physical status I-II and conscious patients of both sexes between the ages of 18 and 65 years suffering from fentanyl-induced itch are included in this study. While patients who have itch secondary to conditions other than intrathecal fentanyl, the history of cardiovascular diseases, or uncontrolled serious systemic disorders are excluded. Then the participants are randomly divided into sumatriptan (6mg), ondansetron (8mg) or placebo groups by block randomization. The primary outcome is comparing the mean of visual analogue scale (VAS) score for itch and the dynamic pruritus score (DPS) over 90 minutes between treatment groups. Likewise, the incidence of side effects, pain VAS intensity scale and nausea 4-point rating score are assessed. Finally, the patients will be asked about their satisfaction with treatment of pruritus.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030432871N1
Registration date:2017-07-24, 1396/05/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-24, 1396/05/02
Registrant information
Name
Ahmad Reza Dehpour
Name of organization / entity
Experimental Medicine Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 3652
Email address
dehpoura@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Brain and Spinal Cord Injury Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study to Evaluate Efficacy and Safety of Sumatriptan and Ondansetron for the Treatment of Intrathecal Fentanyl-Induced Pruritus in Patients Undergoing Spinal Anesthesia
Public title
Sumatriptan and Ondansetron in Treatment of Spinal anesthesia-Induced Pruritus
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vice-chancellor for Research of Tehran University of Medical Sciences, 205th room, 1st floor, Education Bldg, Poursina st.
City
Tehran
Postal code
Approval date
2017-04-03, 1396/01/14
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2007
Health conditions studied
1
Description of health condition studied
Intrathecal fentanyl-induced pruritus
ICD-10 code
L29.8
ICD-10 code description
Other pruritus
Primary outcomes
1
Description
Itch intensity
Timepoint
0, 5, 10, 20, 30, 60 and 90 minutes after the intervention
Method of measurement
VAS score and DPS score
Secondary outcomes
1
Description
Pain intensity
Timepoint
15, 30, 60 and 90 minutes after the intervention
Method of measurement
VAS score
2
Description
Nausea, vomiting intensity
Timepoint
15, 30, 60 and 90 minutes after the intervention
Method of measurement
4-point rating score for nausea and vomiting
3
Description
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
4
Description
Treatment satisfaction
Timepoint
90 minute after the intervention
Method of measurement
Asking the patients
Intervention groups
1
Description
Intervention/Control 1: Sumatriptan 6mg/0.5ml statdose subcutaneous injection + Placebo in volume of 4ml statdose IV injection
Category
Treatment - Drugs
2
Description
Intervention/Control 2: Placebo in volume of 0.5ml statdose subcutaneous injection + Ondansetron 8mg/4ml statdose IV injection
Category
Treatment - Drugs
3
Description
Intervention/Control 3: Placebo in volume of 0.5ml statdose subcutaneous injection + Placebo in volume of 4ml statdose IV injection