The main goal of this study is finding and recommending of new method for relieving pain and delivery of drugs.
Ninety Patients, who were referred to Emergency department of Imam Khomeini Hospital in clinical shifts of researcher, were complaining pain due to acute limb trauma and included for trial, received one of two randomized drug packs.
Patients who had these conditions included to trial: pain with severity index more than 5 of 10 with Numerical Pain Score (NRS); was not in special groups (pregnancy and breast feeding); their health condition was in group one of American Society of Anesthesiology (ASA); had not any chronic use of analgesics and had no addiction (alcohol, opium ...).
Intervention group received intravenous Distilled water as placebo in one minute then nebulized Fentanyl within 5 minutes.
Control group received intravenous Morphine sulfate in one minute then nebulized Distilled water as placebo within 5 minutes.
Patients in both groups asked and monitored for changes in severity of pain as primary outcome and secondary outcomes such as change in cardiac rhythm, level of consciousness, blood pressure, arterial oxygen saturation, respiratory rate and pulse rate. Results documented in 5, 10, 15, 30 and 60 minutes after receiving drugs. Patients who had insufficient response to treatment of pain at time 15 were receiving rescue dose of intravenous Morphine sulfate at times 15 and 30.
At the end patients asked for global satisfaction of this method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012111710585N1
Registration date:2013-03-20, 1391/12/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-20, 1391/12/30
Registrant information
Name
Saeed Shiralizadeh
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7732 5704
Email address
s-shiralizadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
By personal resources and University finance
Expected recruitment start date
2012-11-19, 1391/08/29
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nebulized Fentanyl in relief pain due to acute limb trauma and comparing it with intravenous Morphine sulfate.
Public title
Intravenous Morphine sulfate versus nebulized Fentanyl in patients with acute pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients who presented to our ED and were complaining pain due to acute limb trauma with severity index of pain at least 5 of 10 in Numerical Pain Score (NRS).
Exclusion criteria: special group of patients (pregnant, breast feeding); history of respiratory disease such as asthma; patients who were receiving neuroleptic drugs; patients with chronic pain, opium or alcohol addiction or chronic use of analgesics.
Age
From 16 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
In this study we had two similar packages of drugs that had prepared with study headmaster. Both of them included two 10 milliliter syringes that had filled with clear liquid by headmaster of study; Patients randomly treated with one of the packages that randomized by 4 digits block manner.
Our study is triple blind because researcher, patients and analyzer of results did not know anything about contents of each package.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Room 501, floor 5, Central building of Tehran University of Medical Science
City
Tehran
Postal code
Approval date
2012-10-11, 1391/07/20
Ethics committee reference number
91/D/130/1602
Health conditions studied
1
Description of health condition studied
Acute limb trauma
ICD-10 code
S40, S41,
ICD-10 code description
Superficial injury to shoulder and upper arm, Open wound of shoulder and upper arm, fracture of shoulder and upper arm, Dislocation, sprain and strain of joints and ligaments of shoulder girdle, Superficial injury of forearm, Open wound of forearm, Fractu
Primary outcomes
1
Description
Pain score which is reported by patient.
Timepoint
Five, 10, 15, 30 and 60 minutes after receiving drugs.
Method of measurement
Questionnaire by Numerical Pain Scale(NRS)
Secondary outcomes
1
Description
Respiratory rate.
Timepoint
Five, 10, 15, 30, 60 minutes after receiving drugs.
Method of measurement
Questionnaire
2
Description
Patient's Global rating of satisfaction
Timepoint
One hour after receiving drug via nebulizer
Method of measurement
Questionnaire
3
Description
The period of time between treatment and the onset of analgesia.
Timepoint
Five, 10, 15, 30, 60 minutes after receiving drugs.
Method of measurement
Questionnaire
4
Description
Total dose of rescue dose of Morphine sulfate.
Timepoint
Since 15 minutes after receiving drug via nebulizer
Method of measurement
milligram
5
Description
The percentage of arterial Oxygen saturation.
Timepoint
Five, 10, 15, 30, 60 minutes after receiving drugs.
Method of measurement
Percent
6
Description
Systolic and diastolic blood pressure.
Timepoint
Five, 10, 15, 30, 60 minutes after receiving drugs.
Method of measurement
millimeter of mercury
7
Description
Heart rate.
Timepoint
Five, 10, 15, 30, 60 minutes after receiving drugs.
Method of measurement
Beat per minute
8
Description
Level of consciousness.
Timepoint
Five, 10, 15, 30, 60 minutes after receiving drugs.
Method of measurement
Questionnaire
9
Description
The number of reported nausea or vomiting.
Timepoint
Five, 10, 15, 30, 60 minutes after receiving drugs.
Method of measurement
Questionnaire
Intervention groups
1
Description
In group 1 or intervention group patients received drug and placebo in 2 syringes that were filled by study headmaster. Both of the syringes contained 10 milliliter of clear liquid.
Syringe number 1 contained 10 milliliters distilled water as placebo for intravenous injection by dose of 0.1 milliliter/kilogram of body weight within 1 minute.
Syringe number 2 contained 10 milliliter of 50 Micro gram/milliliter of Fentanyl that build in Iranian drug industry (Daroupakhsh or Abureihan). Fentanyl prescribed via nebulizer by dose of 0.08 milliliter/kilogram equal to dose of four Micro gram/Kilogram within 5 minutes after intravenous drug.
Patients had been monitored for change in pain scale by 10 number Numerical Pain Score (NRS) and side effects in 5, 10, 15, 30 and 60 minutes after receiving drug via nebulizer by asking them with a questionnaire.
Patients who had not reported decrease in pain scale at least 3 number, 15 minutes after nebulized drug, received 1 milligram rescue dose of morphine sulfate intravenously at times 15 and 30 minutes after nebulized drug.
Category
Treatment - Drugs
2
Description
In group 2 or control group patients received drugs in 2 syringes that were filled by study headmaster and both of them contained 10 milliliters of clear liquid.
Syringe number 1 contains 10 milliliters of morphine sulfate; build in Iranian drug industry (Daroupakhsh or Abureihan) that diluted to 1 milligram/milliliter for intravenous injection. Intra venous Morphine sulfate prescribed by dose of 0.1 milliliter/kilogram equal to 0.1 milligram/kilogram of body weight within 1 minute.
Syringe number 2 contains 10 milliliter of distilled water as placebo for prescription via nebulizer by dose of 0.08 milliliter/kilogram within 5 minutes after intravenous drug.
Patients had been monitored for change in pain scale by 10 number Numerical Pain Score (NRS) and side effects in 5, 10, 15, 30 and 60 minutes after receiving drug via nebulizer by asking them via questionnaire.
Patients who had not reported decrease in pain scale at least 3 number, 15 minutes after drugs, received 1 milligram rescue dose of Morphine sulfate intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department of Imam Khomeini Hospital; Tehran University of Medical Science
Full name of responsible person
Dr Shervin Farahmand; Dr Saeed Shiralizadeh
Street address
Emergency Department of Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The vice chancellor for research,The medical school of Tehran University of Medical Science
Full name of responsible person
Dr. shahin akhondzadeh
Street address
The vice chancellor for research, room 206, floor 1, department of education, Medical school of Tehran University of Medical Science, Poursina Ave., Keshavarz Blvd.
City
Tehran
Grant name
پایان نامه رزیدنتی
Grant code / Reference number
19858/210/d/89
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The vice chancellor for research,The medical school of Tehran University of Medical Science
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
Tehran University of Medical Science
Full name of responsible person
Dr. Shervin Farahmand
Position
Assistance professor of emergency medicine
Other areas of specialty/work
Street address
Emergency department of Imam Khomeini's Hospital, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6690 4848
Fax
Email
shfarahmand@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Shervin Farahmand
Position
Assistance professor of emergency medicine
Other areas of specialty/work
Street address
Emergency department of Imam Khomeini's Hospital, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6690 4848
Fax
Email
shfarahmand@sina.tums .ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Saeed Shiralizadeh
Position
Emergency medicine resident
Other areas of specialty/work
Street address
Emergency department of Imam Khomeini's Hospital, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6690 4848
Fax
Email
s-shiralizadeh@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)