Comparison of therapeutic effects of ketamine intranasal and venous fentanyl in patients with renal colic
Design
Patients will randomly be divided into two groups A and B, and each patient will be assigned a code. Special drug and dosing are provided by the triage nurse depending on the patient's code and injected by an emergency doctor.
Settings and conduct
This study will be performed on patients with renal colic in Emergency Hospital of Imam Khomeini Hospital and Golestan Ahvaz in 1397. The study was blind in two ways, the patient and the physician were unaware of the treatment.
Participants/Inclusion and exclusion criteria
In this study, a number of patients suffering from kidney stone pain referring to Imam Khomeini and Golestan Hospitals of Ahwaz with flank pain that radiates to the genitalia, nausea, vomiting, urinary tract and tenderness in the costovertebral region will include in the study. However, opioid-dependent patients received analgesic pain up to 6 hours before entering the ED, refusal of the renal colic due to the presence of stones, history of chronic kidney disease, history of the chronic liver disease, history of ketamine or fentanyl allergies will be excluded from the study
Intervention groups
The first group received intranasal fentanyl 1mg / kg and distilled water IV and the second group received 1mg / kg body weight of 50mg / ml solution of Ketamine I.V and intra-nasal distilled water. Then, the efficacy of the treatment is compared in both groups
Main outcome variables
Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180523039805N1
Registration date:2018-09-01, 1397/06/10
Registration timing:prospective
Last update:2018-09-01, 1397/06/10
Update count:0
Registration date
2018-09-01, 1397/06/10
Registrant information
Name
Seyed alireza Sabouhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2654 4524
Email address
sabouhi.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effects of intranasal ketamine and intravenous fentanyl in the treatment of patients with renal colic
Public title
Compare the efficacy of intranasal ketamine and intravenous fentanyl in patients with kidney pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who suffer from kidney pain caused by kidney stones
Patients who have symptoms of nausea, vomiting and Urinary irritation
Exclusion criteria:
Opioid dependence
History of mental illness
Changes in consciousness
Get an analgesic for 6 hours before entering the emergency department
Unconfirmed renal colic due to the presence of stones
History of seizure
History of chronic kidney disease
Glaucoma
Patients under the age of 15 and over 65 years
History of chronic liver disease
Inability to speak
History of allergy to ketamine or fentanyl
History of chronic respiratory illness
Abnormal brain
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Randomize in two groups with eight unit Permutational blocks. Permuted block randomization is a way to randomly allocate a participant to a treatment group, while maintaining a balance across treatment groups. Each “block” has a specified number of randomly ordered treatment assignments. In this case, We will generate the blocks containing 8 number
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients know they are participating in a study that is aimed to compare the efficacy and side effects of ketamine and Fentanyl in the reduction of renal colic pain but they are not informed that they receive Ketamine or Fentanyl. The physician who evaluates the clinical status of patients and the nurse who injects the drug are not aware of the medication that patients receive. Intranasal or Intravenous distilled water will be used as a placebo
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commite of Jundishapur University of Ahvaz
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6435134551
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.AJUMS.REC.1397.019
Health conditions studied
1
Description of health condition studied
renal colic
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Renal colic severity
Timepoint
before intervention and 5, 15 , 30 minutes after intervention
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group will receive 1 Mg/Kg Ketamine I.V and 1Mg/kg intranasal distilled water
Category
Treatment - Drugs
2
Description
Intervention group: The group will receive 1Mg / kg fentanyl intranasal and 1 mg/kg intravenous distilled water
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Seyed Alireza Sabouhi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
56143661
Phone
+98 61 2267 4822
Email
Sabouhi.a@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Mohammad Badvi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6455134358
Phone
+98 61 8876 1241
Email
Sabouhi.a@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran