1. Home
  2. Approved trials
  3. » فارسی

The comparative effects of paracetamol and fentanyl on pain control during extracorporeal shockwave lithotripsy

Protocol summary

Summary
The aims of this study is to compare 1.The efficacy of paracetamol for pain control during ESWL(extracorporeal shock wave lithotripsy).2.The efficacy of fentanyl for pain control during ESWL .3.The side effects of paracetamol for pain control during ESWL. 4.compare the efficacy and side effects of paracetamol and fentanyl for pain control duringThe side effects of fentanyl for pain control during ESWL. In this randomized single blind study, 105 patients with upper urinary tract stones undergoing SWL were randomly divided into two groups. Group P received 15mg/kg of paracetamol 10 min before procedure, and group F (n = 30) received 1 µg/kg intravenous fentanyl 3 min before procedure. Pain scores assessed with the 10-score linear visual analogue pain scale (VAS).When patients VAS value was over four, supplemental analgesia was administered to both of the groups. VAS scores, systolic and diastolic blood pressure, and peripheral oxygen saturation were recorded before procedure and every 10 minutes during the ESWL. Side effects (nausea, vomiting) and the satisfaction score were recorded.Inclusion Criteria were: patients between 20 to 65 years of age, and having upper ureteric stones6-20mm. Exclusion criteria included: allergy study drugs, moderate to severe hydroureteronephrosis, presence of multiple and/or bladder and/or radiolucent stones, pregnancy, sensory neurological disease. Patients and Methods: In this randomized single blind study, 102 patients with upper urinary tract stones undergoing SWL were randomly divide into two groups. Group A receive 15mg/kg of paracetamol 10 min before procedure, and group F (n = 30) receive 1 µg/kg intravenous fentanyl 3 min before procedure. Pain scores assesse with the 10-score linear visual analogue pain scale (VAS).When patients VAS value is over four, supplemental analgesia administer to both of the groups. VAS scores, systolic and diastolic blood pressure, and peripheral oxygen saturation record before procedure and every 10 minutes during the ESWL. Side effects (nausea, vomiting) and the satisfaction score will record.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016072329034N1
Registration date: 2016-09-01, 1395/06/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-01, 1395/06/11
Registrant information
Name
Ashkan Abdinezhad
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8826 3826
Email address
dr.abdinezhad@gmail.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Science
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effects of paracetamol and fentanyl on pain control during extracorporeal shockwave lithotripsy
Public title
Effects of paracetamol and fentanyl on pain control during extracorporeal shockwave lithotripsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria : patients between 20 to 65 years of age;Patients with American Society of Anesthesiologists (ASA) physical status I or II ;patients having upper ureteric stones6-20mm. Exclusion criteria included: a history of chronic use of analgesics or alcohol; use any analgesic drug within 3 days before the procedure; allergy study drugs; under treatment of sedative or anti-depressant drugs; signs and symptoms of urinary tract infection,;allergy to study drugs;moderate to severe hydroureteronephrosis; presence of multiple and/or bladder and/or radiolucent stones;pregnancy; sensory neurological disease.
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Science
Street address
Iran University of Medical Science, Hemmat freeway, next to Milad tower Tehran,
City
Tehran
Postal code
Approval date
2015-03-16, 1393/12/25
Ethics committee reference number
93/د/105/ 6240

Health conditions studied

1

Description of health condition studied
Calculus of kidney
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter

2

Description of health condition studied
Opioids and related analgesics
ICD-10 code
Y45.0
ICD-10 code description
Opioids and related analgesics

Primary outcomes

1

Description
Pain score
Timepoint
every 10 min until the end of shock wave lithotripsy
Method of measurement
visual analogue scale (VAS)

Secondary outcomes

1

Description
Nausea and Vomiting
Timepoint
after ESWL procedure
Method of measurement
Side effects ranged 1to 3: one related to no nausea, two related to nausea without vomiting and nausea with vomiting is shown with score three

Intervention groups

1

Description
group F receive 1 µg/kg intravenous fentanyl three minutes before ESWL(Extracorporeal shock wave lithotripsy ).When visual analogue pain scale is over 3, supplemental analgesia administere to the group. Intravenous fentanyl 25 micrograms should be given in this condition.
Category
Treatment - Drugs

2

Description
Group A receive 15 mg/kg intravenous paracetamol ten min before ESWL (Extracorporeal shock wave lithotripsy ).When visual analogue pain scale is over 3, supplemental analgesia administere to the group. Intravenous fentanyl 25 micrograms should be given in this condition.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hashemi Nejad Kidney Center
Full name of responsible person
Ashkan Abdinezhad
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Mrs Kordlu
Street address
Iran University of Medical Science, Hemmat freeway, next to Milad tower Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Abdinezhad
Full name of responsible person
Ashkan
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Iran University of medical science
City
Tehran
Postal code
Phone
+98 21 8826 2239
Fax
+98 21 8860 2217
Email
dr.abdinezhad@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Ashkan Abdinezhad
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Hemmat freeway, next to Milad tower Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8826 2239
Fax
+98 21 8860 2217
Email
dr.abdinezhad@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Ashkan Abdinezhad
Position
Residennt of Anesthesiology
Other areas of specialty/work
Street address
Hemmat freeway, next to Milad tower Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8826 2239
Fax
+98 21 8860 2217
Email
dr.abdinezhad@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...