Effectiveness of topical lidocaine-prilocaine cream in comparison with lidocaine-diclofenac cream in reduction of pain caused by central venous catheter implantation
Determination of the effectiveness of topical lidocaine-prilocaine cream in comparison with lidocaine-diclofenac cream in reduction of pain caused by central venous catheter implantation
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 cases using a computer-generated random number table with 4 blocks. In the first group Xyla-P cream and in the second group lidocaine-diclofenac cream are applied. After 45 min CVC is inserted. Patients' pain score during lidocaine injection and CVC placement is determined and recorded based on VAS from 0 to 10. In addition, the physician’s satisfaction with the patient's calmness and rate of restlessness is 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
Intervention group 1: topical lidocaine-prilocaine cream. Intervention group 2: topical lidocaine-diclofenac cream
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:IRCT20180129038549N11
Registration date:2021-05-18, 1400/02/28
Registration timing:retrospective
Last update:2021-05-18, 1400/02/28
Update count:0
Registration date
2021-05-18, 1400/02/28
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
2020-01-15, 1398/10/25
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
2020-01-15, 1398/10/25
Actual recruitment end date
2021-04-20, 1400/01/31
Trial completion date
2021-04-20, 1400/01/31
Scientific title
Effectiveness of topical lidocaine-prilocaine cream in comparison with lidocaine-diclofenac cream in reduction of pain caused by central venous catheter implantation
Public title
Evaluation of the effect of lidocaine-diclofenac 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
Actual sample size reached:
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.
The selected subjects will be divided into each study group in a randomized block method using 6 rows of four blocks (ABAB-BABA-ABBA-BAAB-AABB-BBAA). Xyla-P group (A) and lidocaine-diclofenac group (B). Then, from the created blocks, enough blocks are randomly selected to reach the required sample size. Select the number of blocks from the table of random numbers and based on these numbers, the sequence of blocks in each group will be determined. All this will be done with software called Sealed Envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Lidocaine-diclofenac 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 Sciences
Street address
sfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-05-12, 1398/02/22
Ethics committee reference number
IR.MUI.MED.REC.1398.063
Health conditions studied
1
Description of health condition studied
Procedural pain
ICD-10 code
ICD-10 code description
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
The severity of pain
Timepoint
After lidocaine injection
Method of measurement
Visual Analogue Scale
2
Description
Drug side effects such as redness, whitening and skin blemishes
Timepoint
Every 5 minutes until the time of discharge
Method of measurement
Observation
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. After 45 min local lidocaine is injected and then CVC is inserted.
Category
Treatment - Drugs
2
Description
Intervention group: Patients are treated with lidocaine-diclofenac cream. This cream is a combination of 2% lidocaine and 1% diclofenac 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. After 45 min local lidocaine is injected and then CVC is inserted.