Protocol summary

Study aim
Our study aims to study the analgesic efficacy of the nebulized form ketamine with intravenous paracetamol versus paracetamol alone for post-operative analgesia in pediatric cases undergoing general anesthesia for elective tonsillectomy as a day care procedure.
Design
Prospective Study, parallel group, double blind study, non probability consecutive sampling
Settings and conduct
a double-blind method was used to prevent bias. Participants in group K received intravenous paracetamol 10 mg/kg with nebulized ketamine 2 mg/kg diluted in 5 ml given over 5 minutes 15 minutes before induction whereas group P received intravenous paracetamol 15 mg/kg with nebulization with 5 ml normal saline as placebo 15 minutes before the procedure. The anesthetist preparing the solutions was given sealed non-descript bottles with the nebulizing preparations and the trainee in the operating room did not know of the drug in the nebulizer while also unaware of the study protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria included all ASA-I and II male and female pediatric patients aged 7-12 years coming to the pre-anesthesia clinic for elective tonsillectomy as a day care procedure. Exclusion criteria included patients with any co-morbidity requiring admission, history of upper or lower respiratory tract infection in the last 2 weeks, major cardiovascular abnormalities, un co-operative patients and patients unwilling to be included in the study.
Intervention groups
Patients were divided into two groups K and P with group P to receive intravenous paracetamol 10 mg/kg pre-operatively while group K to receive pre-operative intravenous paracetamol at 10 mg/kg along with nebulized ketamine at 2 mg/kg 15 minutes before induction.
Main outcome variables
Post-operative median pain scores were calculated in the recovery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230809059095N1
Registration date: 2023-09-08, 1402/06/17
Registration timing: retrospective

Last update: 2023-09-08, 1402/06/17
Update count: 0
Registration date
2023-09-08, 1402/06/17
Registrant information
Name
Hassan Minhas
Name of organization / entity
Combined Military Hospital, Rawalpindi, Pakistan
Country
Pakistan
Phone
+92 345 5264734
Email address
h.hassan.nasir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-01, 1400/10/11
Expected recruitment end date
2022-07-31, 1401/05/09
Actual recruitment start date
2022-01-01, 1400/10/11
Actual recruitment end date
2022-07-31, 1401/05/09
Trial completion date
2022-07-31, 1401/05/09
Scientific title
Comparison Of Nebulized Ketamine With Intravenous Paracetamol Versus Paracetamol Alone For Post-Operative Analgesia In Paediatric Day Care Anesthesia
Public title
Efficacy of Nebulized Ketamine for Post-Operative Analgesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA 1 and 2 patients for Elective Tonsillectomy day care procedure Ages 7 - 12 years
Exclusion criteria:
comorbidities requiring admission Respiratory Tract Infections in preceding 2 weeks Uncooperative unwilling patients
Age
From 7 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 181
Actual sample size reached: 190
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were received in the recovery room 1 hour before the procedure and after informed written consent and details of being included in the study, a double-blind method was used to prevent bias. Participants in group K received intravenous paracetamol 10 mg/kg with nebulized ketamine 2 mg/kg diluted in 5 ml given over 5 minutes 15 minutes before induction whereas group P received intravenous paracetamol 15 mg/kg with nebulization with 5 ml normal saline as placebo 15 minutes before the procedure. The anesthetist preparing the solutions was given sealed non-descript bottles with the nebulizing preparations and the trainee in the operating room did not know of the drug in the nebulizer while also unaware of the study protocol.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Combined Military Hospital, Rawalpindi, Pakistan
Street address
CMH Road
City
Rawalpindi
Postal code
46000
Approval date
2021-12-25, 1400/10/04
Ethics committee reference number
261/2021

Health conditions studied

1

Description of health condition studied
Post-Operative Analgesia
ICD-10 code
J02.9
ICD-10 code description
Acute pharyngitis, unspecified

Primary outcomes

1

Description
Post Operative Pain
Timepoint
15, 30, 120 minutes
Method of measurement
Wong Baker faces scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group - ketamine, Participants in this group received intravenous paracetamol 10 mg/kg with nebulized ketamine 2 mg/kg diluted in 5 ml given over 5 minutes 15 minutes before induction
Category
Treatment - Drugs

2

Description
Control group - placebo, This group received intravenous paracetamol 15 mg/kg with nebulization with 5 ml normal saline as placebo 15 minutes before the procedure
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Combined Military Hospital
Full name of responsible person
Hassan Nasir Minhas
Street address
CMH Road
City
Rawalpindi
Postal code
46000
Phone
+92 51 9270163
Email
h.hassan.nasir@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Armed Forces Post Graduate Medical Institute
Full name of responsible person
Hassan Nasir Minhas
Street address
CMH Road
City
Rawalpindi
Postal code
46000
Phone
+92 345 5264734
Email
h.hassan.nasir@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Armed Forces Post Graduate Medical Institute
Proportion provided by this source
100
Public or private sector
Private
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
Armed Forces Post Graduate Medical Institute
Full name of responsible person
HassanNasir Minhas
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 345 5264734
Email
h.hassan.nasir@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Armed Forces Post Graduate Medical Institute
Full name of responsible person
HassanNasir Minhas
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 345 5264734
Email
h.hassan.nasir@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Armed Forces Post Graduate Medical Institute
Full name of responsible person
HassanNasir Minhas
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 345 5264734
Email
h.hassan.nasir@gmail.com

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
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