Clinical trial of the effectiveness of oral clonidine on pain severity and morphine requirement in patients with orthopedic fractures with history of opioids drug abuse in emergency ward
Effectiveness of oral clonidine on pain intensity and morphine requirement in patients with orthopedic fractures
Design
This double-blind randomized clinical trial study with parallel groups will be conducted on 64 patients with orthopedic fractures referred to Shahid Bahonar Hospital in Kerman. Patients participating in the study will be divided into two groups using a table of random numbers.
Settings and conduct
Patients referred to Shahid Bahoner Kerman Orthopedic Fracture Hospital will be included in the study. Patients participating in the study will be divided into two groups using a table of random numbers. The person participating in the study, the researcher and the person collecting the data will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to Shahid Bahonar Hospital in Kerman with orthopedic fractures who have consented to participate in the study. Non-exclusion criteria: It includes patients who do not have hemodynamic stability and suffer from acute and chronic pain.
Intervention groups
Intervention group 1: will receive 0.2 mg of oral clonidine. Intervention group 2: will receive placebo as a control group.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220822055774N1
Registration date:2022-09-20, 1401/06/29
Registration timing:prospective
Last update:2022-09-20, 1401/06/29
Update count:0
Registration date
2022-09-20, 1401/06/29
Registrant information
Name
Masomeh Nazemirafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 2955
Email address
m_nazemi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-01, 1401/08/10
Expected recruitment end date
2023-03-02, 1401/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effectiveness of oral clonidine on pain severity and morphine requirement in patients with orthopedic fractures with history of opioids drug abuse in emergency ward
Public title
Clinical trial of the effectiveness of oral clonidine on pain severity and morphine requirement in patients with orthopedic fractures
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old with bone fractures, and pain score >5 based on VASS
History of opioid drug abuse
Consent to participate in the study
Exclusion criteria:
Pregnancy and breastfeeding women
History of underlying cardio-pulmonary, renal diseases
high blood pressure
Thrombocytopenia
Asthma
Use of narcotics other than morphine
The patient's urgent need for blood transfusion or resuscitation
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization method will be used to allocate samples to intervention and control groups. In this way, an equal number of participants will enter the intervention and control groups at consecutive but equal intervals. Patients in each group will be divided into 6 blocks of 12 people. In this method, one type of treatment is given to the first block and another type to the second and again the first type to the third block and so on. A nurse who was not involved in the study, entered the patients in one of the two groups based on defined blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in the current study, a double-blind method is used so that 1- the person who checks the results and 2- the person who performs the injections does not know which patient received clonidine and which patient received placebo. to be The person responsible for blinding (emergency nurse) will assign a code (01 to 70) to each patient and record it in the questionnaire. In this way, the intervention group received 0.2 mg of oral clonidine (23) and the control group received the same form of placebo pill. The person responsible for blinding will receive
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences campus, Haft Bagh Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616914115
Approval date
2022-09-10, 1401/06/19
Ethics committee reference number
IR.KMU.REC.1401.262
Health conditions studied
1
Description of health condition studied
Bone fracture
ICD-10 code
M96.6
ICD-10 code description
Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention and 30 minutes, 1 hour, 3 hours and 6 hours after the intervention