Effects of inhalation of rosemary fragrance on alleviating post orthopedic surgery pain(hip prosthesis placement) in ICUpatients
Design
Clinical trial with control group, with parallel group, three-way blind, randomized, phase 3 on 64 patients. For randomization,a table of random numbers has been used,
Settings and conduct
Patients who are candidates for orthopedic surgery (implantation of hip prosthesis) admitted to Imam Hospital. Aftersurgery patients are divided into 2 main groups. Intervention group of gas impregnated with 3% rosemary essential oil andcontrol group of gas soaked in sweet almond oil are attached to their clothes at a distance of 20 cm from their noses.Anesthesia method for both groups in the operating room is general anesthesia with the same drugs. Blinding is performed onpatients, evaluators and data analysts in 3 directions.
Participants/Inclusion and exclusion criteria
Admission requirements: Patients aged 18-70 years with ASA class III maximum candidate for at least 24 hours stay in ICUafter orthopedic surgery and implantation of hip prosthesis. Conditions for not entering the study: Drug dependence, pregnancyand lactation, dissatisfaction, allergy to rosemary any length of surgery or complications during and after surgery and out of thesame care, routine user of any analgesic in the period of 2 months before surgery, uncontrolled high blood pressure, Epilepsy.
Intervention groups
In the intervention group: inhalation of gas impregnated with 3% rosemary essential oil is performed. Control group:inhalation of gas soaked in sweet almond oil.
Main outcome variables
Pain before and after intervention in two groups of patients; morphine use
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211102052945N1
Registration date:2022-05-16, 1401/02/26
Registration timing:retrospective
Last update:2022-05-16, 1401/02/26
Update count:0
Registration date
2022-05-16, 1401/02/26
Registrant information
Name
Abbas Mohaddes Hakkak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3762 9230
Email address
a.mh95@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of inhalation of rosemary fragrance on alleviating post orthopedic surgery pain(hip prosthesis placement) in ICU patients
Public title
Effects of inhalation of rosemary fragrance on alleviating pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-70 year old
ASA class III maximum
Candidate for at least 24 hours stay in ICU
Post orthopedic surgery and implantation of hip prosthesis
Exclusion criteria:
Drug addiction
Pregnancy and lactation
Dissatisfaction
Allergy to rosemary
Any length of surgery or complications during and after surgery and leaving the same care
Routine user of any analgesic in the period of 2 months before surgery
Uncontrolled high blood pressure
Epilepsy
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
64
More than 1 sample in each individual
Number of samples in each individual:
9
For all patients upon arrival and every 3 hours
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers using the site: www.randomization.com
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is a three-way blind study that includes participants, evaluators and data analysts.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2021-01-19, 1399/10/30
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.202
Health conditions studied
1
Description of health condition studied
Acute pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Patients' pain score based on NSR questionnaire
Timepoint
Measure the patient's pain at the time of admission to the ICU and every 3 hours for up to 24 hours
Method of measurement
Numeric Rating Scale questionnaire
Secondary outcomes
1
Description
Amount of morphine used
Timepoint
If necessary, once every ten minutes
Method of measurement
Record the prescribed drug by dose
Intervention groups
1
Description
Intervention group: All patients undergo anesthesia after pre-medication with 1 mg midazolam and 3 micrograms/kg fentanyl with 2 mg/kg propofol and 0.5 mg/kg atracurium. At the end of the surgery, the patient is admitted to the surgical ICU after extubation and without recovery and receives the same care. For all patients, at the beginning of admission and every 3 hours, pain determination is performed according to the NRS scoring system and if the score is more than 3, 0.05 mg/kg of intravenous morphine is prescribed every 10 minutes to reduce the pain score to less than 4. In addition to these treatments, in the intervention group, a gauze impregnated with 5 drops of 3% rosemary essential oil (about one cc of essential oil on a 5*5 cm gauze) will be pinned to the patient's shirt and will be renewed every three hours. The score of pain and the required dose of morphine will be recorded every 3 hours for 24 hours.
Category
Treatment - Drugs
2
Description
Control group: All patients undergo anesthesia after pre-medication with 1 mg midazolam and 3 micrograms/kg fentanyl with 2 mg/kg propofol and 0.5 mg/kg atracurium. At the end of the surgery, the patient is admitted to the surgical ICU after extubation and without recovery and receives the same care. For all patients, at the beginning of admission and every 3 hours, pain determination is performed according to the NRS scoring system and if the score is more than 3, 0.05 mg/kg of intravenous morphine is prescribed every 10 minutes to reduce the pain score to less than 4. In addition to these treatments, in the control group, a gauze impregnated with 5 drops of sweet almond oil (about one cc of oil on a 5*5 cm gauze) will be pinned to the patient's shirt and will be renewed every three hours. The score of pain and the required dose of morphine will be recorded every 3 hours for 24 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Arash Peivandi Yazdi
Street address
Department of anesthesia, Imam Reza Hospital, Ibne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3885 3858
Email
peivandia@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi apartment, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3885 3858
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arash Peivandi Yazdi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3885 3858
Email
peivandia@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arash Peivandi Yazdi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3885 3858
Email
peivandia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arash Peivandi Yazdi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesia, Imam Reza Hospital, Ibne Sina Street, Mashhad
City
Mashhsd
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3885 3858
Email
peivandia@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available