Comparison of efficacy of intravenous infusion of lidocaine vs pethidine on numerical rating scale (NRS) of pain in femoral fractures
Design
It is a randomized double blinded clinical trial with two parallel group (lidocaine and pethidine groups). The study population is 72 patients. We used www.sealedenvelope.com for randomization.
Settings and conduct
Patients administered to 501, Khanevadeh, Golestan, and Besat hospitals will be included to the study according to the inclusion and exclusion criteria. All patients will be monitored for vital signs and oxygen saturation. 3 mg/kg of lidocaine is intravenously administered within 20 minutes for lidocaine group. Pethidine group will receive 25 mg of intravenous pethidine. We will use numerical rating scale (NRS) for pain measurement. The list of randomization blocks and treatment groups will be provided to anesthesiologist. General practitioner, emergency physician, patients, and statistician will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Age more than 18 years-old
2. Femoral bone fracture
3. Severe pain based on NRS (NRS>=7)
Exclusion Criteria:
1. Age more than 70 years-old
2. Crush injury of limb and open fractures
3. Acute diseases except of fractures
4. Pregnancy
5. Presence or history of cardiac block or bradycardia
6. Presence or history of seizure
7. Neuromuscular diseases
8. Neuropathic disease
9. Diabetes
10. History of consumption of analgesic or anti-inflammatory drugs
11. History of opioids consumption
12. Allergic history of lidocaine and pethidine
Intervention groups
3 mg/kg of lidocaine is intravenously administered within 20 minutes for lidocaine group. Pethidine group will receive 25 mg of intravenous pethidine.
Main outcome variables
1. Pain severity (based on NRS) 60 minutes after drug administration
2. Incidence of adverse events in each treatment group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231213060355N1
Registration date:2023-12-30, 1402/10/09
Registration timing:prospective
Last update:2023-12-30, 1402/10/09
Update count:0
Registration date
2023-12-30, 1402/10/09
Registrant information
Name
Mehrshad Namazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8350
Email address
dr.m.namazi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Venous Infusion of Lidocaine and Intravenous Injection of Pethidine for the Management of Acute Pain Due to Femoral Fractures
Public title
Analgesic Effect of Intravenous Lidocaine in Femoral Fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age >= 18 years-old
Femoral bone fracture
Severe pain based on numerical rating scale of pain (NRS) (NRS>=7)
Exclusion criteria:
Age > 70 years-old
Crush injury of limb and open fractures
Acute diseases except of fractures
Pregnancy
Presence or history of cardiac block or bradycardia
Presence or history of seizure
Neuromuscular diseases
Neuropathic disease
Diabetes
History of consumption of analgesic or anti-inflammatory drugs
History of opioids consumption
Allergic history of lidocaine and pethidine
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is used for randomization of participants. We will use www.sealedenvelope.com website for randomization and providing blocks. The block sizs is 4. The treatment groups will be "A" and "B".
Blinding (investigator's opinion)
Double blinded
Blinding description
The list of randomization blocks and treatment groups will be provided to anesthesiologist. Anesthesiologist will define the treatment groups A and B (lidocaine and pethidine). General practitioner, emergency physician, and statistician will not access to the list and they are blinded. Type of treatment groups and drugs (A and B) will not be provided to research contributors, except anesthesiologist. Before enrolment, written informed consent will be obtained from study participants. However, type of drugs will not be provided to patients. At the end of the study, statistician and general physician will analyze the data.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, for the first time we will evaluate the efficacy of infusion of intravenous lidocaine (3 mg/kg/20 minutes) in patients with femoral bone fractures compared to intravenous pethidine (in emergency room). If the intravenous lidocaine shows
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of AJA University of Medical Sciences
Street address
AJA university of medical sciences, Etemad zadeh street, Fatemi-Gharbi Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.AJAUMS.REC.1402.168
Health conditions studied
1
Description of health condition studied
Femoral bone fracture
ICD-10 code
S72
ICD-10 code description
Fracture of femur
Primary outcomes
1
Description
Numerical Rating Scale of Pain
Timepoint
Before drug administration, 10, 20, 30, 40, 50, 60 minutes after drug administration
Method of measurement
Visual Analogue Scale (VAS) for Pain
Secondary outcomes
1
Description
Drug adverse events
Timepoint
During the 4 hours after drug administration
Method of measurement
Vital sign monitoring and evaluating the signs and symptoms
Intervention groups
1
Description
Intervention group: Intravenous infusion of lidocaine (3 mg/kg during 20 minutes, Maximum dose 200 mg)