Topical Ketamine Analgesia in Children Undergoing Tonsillectomy: a Clinical and Serum Level Assays Study.
Topical Ketamine by Neubulization Method in Tonsillectomy
1 other identifier
interventional
100
1 country
1
Brief Summary
The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two different doses in pediatric patients undergoing tonsillectomy operations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 postoperative-pain
Started Apr 2016
Longer than P75 for phase_2 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2016
CompletedFirst Posted
Study publicly available on registry
March 25, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 7, 2019
June 1, 2019
2.7 years
March 22, 2016
June 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative analgesic consumption
The total amount of analgesics used in the first 24h postoperative in mg.
24 hours postoperative
Secondary Outcomes (2)
Postoperative pain scores
24 hours postoperative
Ketamine serum levels to exclude systemic absorption of topical ketamine.
120 min after receiving Ketamine
Study Arms (4)
Intravenous ketamine0.5mg/kg
ACTIVE COMPARATORintravenous ketamine 0.5 mg/kg given after induction of anesthesia and before surgery.
Nebulized ketamine 1mg/kg
ACTIVE COMPARATORnebulized ketamine group received 1mg/kg ketamine by nebulzation before induction of anesthesia.
Nebulized ketamine 2mg/kg
ACTIVE COMPARATORnebulized ketamine group received 2mg/kg ketamine by nebulzation before induction of anesthesia.
control group
PLACEBO COMPARATORcontrol group received placebo nebulization
Interventions
Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.
Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.
Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.
Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.
Eligibility Criteria
You may qualify if:
- ASA physical status I-II patients aged 7-12 years and scheduled for elective tonsillectomy due to recurrent or chronic tonsillitis will be included in the study
You may not qualify if:
- patients with known hypersensitivity to medication drugs, coagulation disorders, thrombocytopenia, and significant cardiac, renal, pulmonary or hepatic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university hospitals
Asyut, Assiut Governorate, Egypt,71571, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hala S Abdel-Ghaffar, MD
Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 22, 2016
First Posted
March 25, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
June 7, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share