Effectiveness of topical lidocaine-prilocaine cream in comparison with lidocaine-ibuprofen combination cream in reduction of pain during central venous catheterization
After obtaining the code of ethics from the ethics committee of Isfahan University of Medical Sciences and obtaining written consent from 100 eligible patients, they are divided into two groups of 50 using random-allocation software package. In the first group Xyla-P cream and in the second group lidocaine-ibuprofen cream are applied. After 45 min CVC is inserted. Patients' pain score during lidocaine injection and CVC placement is determined and recorded based on Visual Analog Score from 0 to 10. In addition, the physician’s satisfaction with the patient's calmness and rate of restlessness was recorded based on a score of 0 (completely dissatisfied) to 10 (completely satisfied)
Participants/Inclusion and exclusion criteria
Inclusion criteria: All alert adult patients admitted to the emergency department of Al-Zahra and Kashani hospitals and requiring CVC insertion. Exclusion criteria: The presence of visual, mental, and verbal disorders - History of drug addiction- Allergic reaction to local anesthetics - Those who are in a life-threatening condition-, History of analgesic use within 24 hours before the procedure
Intervention groups
En Patients over the age of 18 who are taking topical lidocaine-ibuprofen cream to reduce the pain associated with CVC insertion
Main outcome variables
The severity of pain is measured based on the VAS scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180129038549N10
Registration date:2021-05-12, 1400/02/22
Registration timing:prospective
Last update:2021-05-12, 1400/02/22
Update count:0
Registration date
2021-05-12, 1400/02/22
Registrant information
Name
Farhad Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 8804
Email address
drfarhadheydari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-16, 1400/02/26
Expected recruitment end date
2021-07-17, 1400/04/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of topical lidocaine-prilocaine cream in comparison with lidocaine-ibuprofen combination cream in reduction of pain during central venous catheterization
Public title
Evaluation of the effect of lidocaine-ibuprofen cream in reducing local pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All adult patients referred to the emergency department of al-Zahra and Kashani hospitals Need for Central Venous Catheter Insertion
Alert
Stable vital signs
Exclusion criteria:
Visual, mental, or verbal disorders
History of favism, methemoglobin, renal and liver disease
Skin diseases at or around the CVC insertion site
History of drug addiction
History of analgesic use within 24 hours before the procedur
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After the arrival of the patients to the emergency department, they are divided into 2 groups by a computer-generated random number table with 4 blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
First, Lidocaine-ibuprofen cream is prepared by the Faculty of Pharmacy of Isfahan University of Medical Sciences and the same is packed with Xyla-P cream, and then numbered and given to the nurse. The nurse and the physician and the patient do not know the ointment content.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.MUI.MED.REC.1398.703
Health conditions studied
1
Description of health condition studied
Procedural pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
The severity of pain
Timepoint
After central venous catheter (CVC) insertion
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Drug side effects such as redness, whitening and skin blemishes
Timepoint
Until the time of discharge
Method of measurement
Standard questionnaire form
2
Description
The severity of pain
Timepoint
After lidocaine injection
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Patients are treated with Xyla-P cream. A 5% Xyla-P cream is a combination of 2.5% lidocaine and 2.5% perlocaine produced by Iranian chemistry company Iran. For each patient, 2 grams of 5*5 cm spam cream are applied and then covered with gas.
Category
Treatment - Drugs
2
Description
Intervention group: Patients are treated with lidocaine-ibuprofen cream. This cream is a combination of 2% lidocaine and 5% ibuprofen and is prepared with the Faculty of Pharmacology (Isfahan University of Medical Sciences). . For each patient, 2 grams of 5*5 cm spam cream are applied and then covered with gas.