Objectives: Pain management is one of the major tasks of any emergency department. Finding a way to better control of pain can result in decreasing staff workload and increasing patient's satisfaction. Design:This is a double blind randomized placebo controlled clinical trial.
Setting: This study will be conducted in 3 university hospital emergency departments with 120000 overall annual census.
Participant: In this study trauma patients with extremity fracture and verbal numerical pain score (VNRS) more than six between 15 and 60 years old who need admission will be approached. Those with history of addiction, distracting injury and any contraindication to morphine or pregabalin will be excluded.
Intervention: They will divided into two group. First group will receive morphine 5 mg with placebo and second group will receive morphine 5 mg and pregabalin 300 mg.
Main outcome measures: VNRS and side effects will record in 0-10-30-60 minutes and after that every hour to 6 hours. After 30 minutes if VNRS is above 4, patient will receive rescue dose of morphine 5mg. Total 24 hour morphine doses will be recorded. At the end we will compare VNRS, need to rescue analgesic, side effects and total 24 hour morphine use in these groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412198104N10
Registration date:2015-01-25, 1393/11/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-25, 1393/11/05
Registrant information
Name
Mohammad Amin Zare
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
ma-zare@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous morphine with morphine plus Pregabalin in trauma patients with extremities' fracture and severe pain
Public title
Pregabalin in trauma pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Trauma patients with extremity fracture; Verbal Numeric pain score more than 6; Age between 15 or 60
Exclusion Criteria
Addiction; Any contraindication for morphine or Pregabalin; Any other distracting injury; Inability to cooperate
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences' Ethics comittee
Street address
Hemmat Highway, Cross with Sheikh Fazlollah Highway
City
Tehran
Postal code
Approval date
2014-11-12, 1393/08/21
Ethics committee reference number
93/d/105/3390
Health conditions studied
1
Description of health condition studied
Pain in extrimity fracture
ICD-10 code
XIX
ICD-10 code description
Injury, poisoning and certain other consequences of external causes
Primary outcomes
1
Description
Severity of pain
Timepoint
0-10 minutes-30 minutes- 1 hour- 6 hours- 12 hours- 18 hours and 24 hours after intervention.
Method of measurement
Using Verbal Numerical Rating Scale (VNRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group receive morphine 5mg and pregabalin 300mg
Category
Treatment - Drugs
2
Description
Control group will receive morphine 5 mg and placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Mohammad Amin Zare
Street address
Niyayesh St, Sattarkhan Ave
City
Tehran
2
Recruitment center
Name of recruitment center
7th Tir Martyrs Hospital
Full name of responsible person
Mohammad Amin Zare
Street address
Shahid Radjayi Blvd.
City
Tehran
3
Recruitment center
Name of recruitment center
Firouzgar hospital
Full name of responsible person
Mohammad Amin Zare
Street address
Vali Asr Sq. Beh Afarid Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellorfor Research; Iran University of Medical Sciences
Full name of responsible person
Mohammad Amin Zare
Street address
Sattarkhan Ave, Niyayesh St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellorfor Research; Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Amin Zare
Position
Assisstant Professor
Other areas of specialty/work
Street address
Hemmat Hwy, Cross with Sheikh Fazlollah Hwy
City
Tehran
Postal code
14456
Phone
+98 21 6652 5327
Fax
Email
mazare74@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of medical sciences
Full name of responsible person
Mohammad Amin Zare
Position
Assisstant Professor
Other areas of specialty/work
Street address
Hemmat Highway, Cross with Sheikh Fazlollah Highway
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
mazare74@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Amin Zare
Position
Assisstant Professor
Other areas of specialty/work
Street address
Hemmat Hwy, Cross with Sheikh Fazlollah Hwy
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
mazare74@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)