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Investigating the effect of half percent oxymetazoline nasal drops on cough, sore throat and bleeding in children after tonsillectomy

Protocol summary

Study aim
Determining the effect of oxymetazoline on cough, sore throat and bleeding in children undergoing tonsillectomy
Design
The randomized, double-blind clinical trial, with the parallel groups, Phase 3 on 88 patients
Settings and conduct
In this randomized double-blind clinical trial study, 88 eligible children, referred to Al-Zahra Hospital in Isfahan, will be included in the study and will be randomly divided into two groups. Oxymetazoline 0.5% nasal spray will be prescribed for patients in the first group, and distilled water spray will be prescribed for the second group. The intervention will be performed in such a way that the patient and the researcher will not have any knowledge of the type of intervention and double-blind conditions will be established. Then the cough, sore throat and bleeding rate of the children will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria involved patients aged 6-12 years, candidates of tonsillectomy, having ASA I or II. Exclusion criteria include having hypertension, sensitivity to oxymetazoline, and taking painkillers, antinausea, steroids, and antihistamines within 15 hours before surgery.
Intervention groups
Intervention group: In this group, 0.5% Oxymetazoline nasal spray is prescribed as one puff in each nostril immediately after the induction of anesthesia. Then, 12 hours after the start of tonsillectomy, nasal spray is prescribed again in both nostrils. Control group: In this group, distilled water spray is prescribed immediately after induction of anesthesia as one puff in each nostril. Then, 12 hours after the start of tonsillectomy, nasal spray is prescribed again in both nostrils.
Main outcome variables
Cough; Sore throat; Bleeding rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110528006617N7
Registration date: 2022-08-16, 1401/05/25
Registration timing: prospective

Last update: 2022-08-16, 1401/05/25
Update count: 0
Registration date
2022-08-16, 1401/05/25
Registrant information
Name
Mehrdad Masoudifar
Name of organization / entity
Esfahan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1268 2007
Email address
masoudifar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-22, 1401/06/31
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of half percent oxymetazoline nasal drops on cough, sore throat and bleeding in children after tonsillectomy
Public title
The effect of oxymetazoline nasal drops on cough, sore throat and bleeding in children after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for tonsillectomy surgery Ages between 6-12 years American Society of Anesthesiology (ASA) classification equal to I or II Parents' consent to participate in the study
Exclusion criteria:
Having hypertension Sensitivity to oxymetazoline Children who received analgesics, anti-nausea, asteroids, and antihistamines during the 15 hours prior to surgery Taking painkillers, antinausea, steroids, and antihistamines within 15 hours before surgery
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 88 eligible children are randomly selected. For this, the letter A is written on 40 sheets, and the letter B is written on 40 sheets and each of them is placed in an envelope. Each The child's parents is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
To comply with the blinding terms, both nasal sprays are prepare in advance by the pharmacist in the same shape, color, and smell and in the same boxes with the same volume and are coded with A, B labels and are made available daily to the surgical team in the operating room.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.MUI.MED.REC.1400.377

Health conditions studied

1

Description of health condition studied
Tonsillectomy surgery
ICD-10 code
J35.01
ICD-10 code description
Chronic tonsillitis

Primary outcomes

1

Description
Bleeding rate
Timepoint
During surgery and hospitalization in the ward
Method of measurement
Measuring the suction bottle and weightening of bloody gazes

2

Description
Sore throat
Timepoint
upon entering the recovery room and at minutes 15, 30, 45, and 60 of recovery as well as upon entering the ward and minutes 15, 30, 45, and 60 being in the ward
Method of measurement
Visual Analogue Scale (VAS)

3

Description
Cough
Timepoint
From admission to recovery room until 24 hours after extubation
Method of measurement
Observational

Secondary outcomes

1

Description
Heart rate
Timepoint
The beginning of recovery and at minutes 15, 30, 45, and 60 of recovery
Method of measurement
Monitoring device

2

Description
Systolic blood pressure
Timepoint
The beginning of recovery and at minutes 15, 30, 45, and 60 of recovery
Method of measurement
Monitoring device

3

Description
Diastolic blood pressure
Timepoint
The beginning of recovery and at minutes 15, 30, 45, and 60 of recovery
Method of measurement
Monitoring device

Intervention groups

1

Description
Intervention group: In this group, 0.5% Oxymetazoline nasal spray (Raha Pharmaceutical Company) is prescribed as one puff in each nostril immediately after the induction of anesthesia. Then, 12 hours after the start of tonsillectomy, nasal spray is prescribed again in both nostrils.
Category
Treatment - Drugs

2

Description
Control group: In this group, distilled water spray is prescribed immediately after induction of anesthesia as one puff in each nostril. Then, 12 hours after the start of tonsillectomy, nasal spray is prescribed again in both nostrils.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital, Isfahan
Full name of responsible person
Mehrdad Masoudifar
Street address
Department of Anesthesiology, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
masoudifar@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad masoudifar
Position
Associate Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
masoudifar@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad masoudifar
Position
Associate Professor of Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
masoudifar@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sheida Mosharaf
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Fax
Email
Sheida.mosharaf@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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