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Efficacy of postoperative nebulized ketamine for pain management after tonsillectomy in children: a randomized controlled trial

Protocol summary

Study aim
To determine the efficacy and safety of postoperative nebulized ketamine in reducing pain and improving recovery outcomes after tonsillectomy in children, aiming to provide evidence for an opioid-sparing analgesic strategy in pediatric surgery.
Design
Prospective, randomized, double-blind, placebo-controlled clinical trial Randomization: Stratified block randomization (1:1 allocation) into Group K (nebulized ketamine) or Group P (placebo), stratified by age (5-7 vs. 8-12 years) to minimize confounding. Computer-generated sequence stored securely by a research pharmacist; allocation concealed using opaque, sealed envelopes. Blinding: Double-blind. Patients, parents/guardians, clinicians (surgeons, anesthesiologists, nurses), and outcome assessors blinded. Nebulized ketamine and saline prepared in identical vials/syringes, labeled with unique study numbers, indistinguishable in appearance.
Settings and conduct
Taleghani care university hospital’s pediatric surgical ward and PACU. Patients, parents/guardians, clinicians (surgeons, anesthesiologists, nurses), and outcome assessors blinded.
Participants/Inclusion and exclusion criteria
Inclusion: ASA I-II, no ketamine allergy, no psychiatric/neurological disorders, chronic pain syndromes, severe asthma, or recent respiratory infections. Exclusion: Emergency surgery, recent opioid use.
Intervention groups
Nebulized ketamine (1 mg/kg, max 50 mg, diluted in 5 mL saline) administered via standard nebulizer device in the PACU, delivered over 10-15 minutes under continuous monitoring
Main outcome variables
To determine the efficacy and safety of postoperative nebulized ketamine in reducing pain and improving recovery outcomes after tonsillectomy in children, aiming to provide evidence for an opioid-sparing analgesic strategy in pediatric surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251109067931N1
Registration date: 2026-01-24, 1404/11/04
Registration timing: registered_while_recruiting

Last update: 2026-01-24, 1404/11/04
Update count: 0
Registration date
2026-01-24, 1404/11/04
Registrant information
Name
Mohsen Ariannik
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1290
Email address
dr.ariannik@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-01-20, 1404/10/30
Expected recruitment end date
2027-01-20, 1405/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of postoperative nebulized ketamine for pain management after tonsillectomy in children: a randomized controlled trial
Public title
nebulized ketamine for pain management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 5-12 years scheduled for elective tonsillectomy ASA I-II
Exclusion criteria:
ketamine allergy psychiatric/neurological disorders chronic pain syndromes severe asthma recent respiratory infections Emergency surgery recent opioid use
Age
From 5 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified block randomization (1:1 allocation) into Group K (nebulized ketamine) or Group P (placebo), will be stratified by age (5-7 vs. 8-12 years) to minimize confounding. Computer-generated sequence will be stored securely by a research pharmacist; allocation will be concealed using opaque, sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, parents/guardians, clinicians (surgeons, anesthesiologists, nurses), and outcome assessors will be blinded. Nebulized ketamine and saline prepared in identical syringes, labeled with unique study numbers, indistinguishable in appearance.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
7th Floor, Bldg No.2 SBMU, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
193954631
Approval date
2026-01-13, 1404/10/23
Ethics committee reference number
IR.SBMU.MSP.REC.1404.690

Health conditions studied

1

Description of health condition studied
post operative pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
Numeric rating scale (NRS) pain score
Timepoint
Pain is assessed at baseline, 15, 30, 60, 90, 120 minutes, and 4, 8, 12, 24, and 48 hours post-operatively.
Method of measurement
Numeric rating scale (NRS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: nebulized ketamine (1 mg/kg, max 50 mg) administered via jet nebulizer 15 minutes in the post-anesthesia care unit (PACU)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani university hospital
Full name of responsible person
Mohsen Arian Nik
Street address
Beside Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Valenjak, Tehran
City
tehran
Province
Tehran
Postal code
1985717412
Phone
+98 21 2303 1290
Email
info@sbmu.ac.ir
Web page address
https://taleghani.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Bldg No.2 SBMU, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Arian Nik
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Valenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717412
Phone
+98 21 2303 1290
Email
dr.ariannik@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Arian Nik
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Valenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717412
Phone
+98 21 2303 1290
Email
dr.ariannik@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Arian Nik
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Valenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717412
Phone
+98 21 2303 1290
Email
dr.ariannik@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after individuals are anonymized.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
Each member of the academic staff or student by requesting via academic email.
From where data/document is obtainable
email to: dr.ariannik@gmail.com m.ariannik@sbmu.ac.ir
What processes are involved for a request to access data/document
Three to seven working days after receiving the email.
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