Determining the effect of body wash with Marshmallow and Acetaminophen on children's temperature
Design
A clinical trial study with Intervention and Control groups, with Parallel groups, Double blind, Phase 3, on 92 children in two groups, Randomization Will do by random number table
Settings and conduct
Shahid Madani Hospital in Khorramabad, initially measuring the tympanic temperature with a Beurer tympanic thermometer for 30 seconds.
In both groups, the temperature of room, lukewarm water and Marshmallow extract, gauze surface; the children’s temperature, Pulse rate and possible complications (Chills, tachycardia and confusion) will be recorded at similar times.
The study is double blind: Measurement and recording of temperature will do by a researcher assistant who will not be aware of the type of wet sponge solution; also, the statistical consultant will be unaware of the groups when analyzing information.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Satisfaction to participate
Age 6 months to 12 years
Tympanic temperature more than 38.3 ° C
Receiving Acetaminophen suppository
Do not take any medicine other than Acetaminophen
No history of febrile seizure in the child and family
No history of specific and chronic disease
No history of taking certain medications
No history of allergy to Acetaminophen and medicinal herbs
Proper hydration
Do not take steroid drugs
Exclusion criteria:
Reluctance and dissatisfaction to continue participating in the study Refractory fever higher than 40 ° C
Intervention groups
Control group: At the same time as receiving Acetaminophen Suppository will receive wet sponge with lukewarm water.
Intervention group: Simultaneously with receiving Acetaminophen suppository, will receive wet sponge with white Marshmallow extract
Main outcome variables
Children's fever
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200809048345N1
Registration date:2020-08-31, 1399/06/10
Registration timing:prospective
Last update:2020-08-31, 1399/06/10
Update count:0
Registration date
2020-08-31, 1399/06/10
Registrant information
Name
Hadis Goodarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0155
Email address
h73goodarzi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Wet Sponge by Marshmallow along with Acetaminophen on children's fever
Public title
The effect of wet sponge by marshmallow on children's fever
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Parental satisfaction and children's assent to participate in research
Children 6 Months to 12 Years
Tympanic temperature more than 38.3 ° C
Taking Acetaminophen Suppository to reduce body temperature
Do not take any medication other than Acetaminophen to reduce fever
No history of Febrile Seizures in the Child and Family
No history of specific and chronic disease
No history of taking certain medications
No history of allergy to Acetaminophen and medicinal plants (Marshmallow) in children and families
Proper hydration
Do not take Steroids drugs
Exclusion criteria:
Taking any other drug antipyretic drug other than Acetaminophen during treatment
Children or parents refuse continuing to participate in research
Fever more than 40 ° C that do not respond to treatment
Age
From 6 months old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
The Patients are aassigned to two groups by Stratified random method, in which the strata will made based on the type of disease /diagnosis, the age and sex of child. Within each stratum, the method of blocks random allocation will use to assign the samples to the intervention or control groups. The Blocks will be binary and the randomization tool is the table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Study will conduct in double blind directions; as the temperature will measure and record by a researcher assistant who will not aware of the type of the solution for wet sponge; also, the statistical consultant will be unaware of the type of intervention when analyzing the data.
Placebo
Not used
Assignment
Parallel
Other design features
In the intervention group, at the same time as receiving Acetaminophen suppository will receive wet sponge with white Marshmallow extract in the amount of one liter and the temperature of 28.84 ± 1.8 ° C. The Control Group, simultaneously with receiving Acetaminophen suppository, will receive wet sponge with lukewarm water at the amount of one liter and the temperature of 28.84± 1.8 ° C. In both groups, The temperature of room , Lukewarm water and Marshmallow extract , Gas surface temperature and the children’s temperature, Pulse rate and possible complications ( Chills , tachycardia and confusion) will be recorded at similar times
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
School of Nursing and Midwifery, Lorestan University of Medical Sciences, The 4th kilometer of Khorramabad-Borujerd road
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Approval date
2020-08-04, 1399/05/14
Ethics committee reference number
IR. LUMS. REC. 1399. 087
Health conditions studied
1
Description of health condition studied
Children's fever
ICD-10 code
R50.8
ICD-10 code description
Other specified fever
Primary outcomes
1
Description
The mean decrease of children’s temperature
Timepoint
At the start of study, every 15 minutes to an hour and at the 4th and 6th hours after the start of the study
Method of measurement
Tympanic thermometer (Beurer brand)
Secondary outcomes
1
Description
The Frequency of children with normal temperature
Timepoint
At the start of the study, every 15 minutes to an hour and at the 4th and 6th hours after the start of the study
Method of measurement
Tympanic thermometer (Beurer brand)
2
Description
The time to return the temperature to normal values
Timepoint
At the start of study, every 15 minutes to an hour and at the 4th and 6th hours after the start of the study
Method of measurement
Tympanic thermometer (Beurer brand)
3
Description
The frequency of children’s need to receive the next dose of Acetaminophen
Timepoint
The 4th and 6th hours after the start of the study
Method of measurement
Tympanic thermometer (Beurer brand)
Intervention groups
1
Description
Intervention group: Simultaneously with receiving acetaminophen suppository, will receive wet sponge with the white marshmallow extract at the temperature of 28.84 ± 1.8 ° C. To prepare the extract, 5 to 10 grams of grind flowers of white Marshmallow (5 grams for the 6 months to 10 years old children and 10 grams for the 10 to 12 years old children) will mixed and stored in 1 liter of 20 ° C temperature water for 8 hours. . Then the flower extract will take with a filter. Preparation of the white marshmallow extract will do in the laboratory with observing the principles of extracting by the member of project team under the supervision of a pharmacist.
Category
Other
2
Description
Control group: The Control Group at the same time, as receiving acetaminophen suppository, will receive wet sponge with lukewarm water at the amount of one liter and the temperature of 28.84± 1.8 ° C