|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03347916 |
|
Date of registration:
|
14/11/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation
|
|
Scientific title:
|
The Role of Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation and Delirium in Children After Strabismus Surgery: A Prospective Randomized Double-blind Study |
|
Date of first enrolment:
|
January 5, 2017 |
|
Target sample size:
|
75 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03347916 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Kuwait
| | | | | | | |
|
Contacts
|
|
Name:
|
Nicolas Abou chaar, MSSc |
|
Address:
|
|
|
Telephone:
|
+96597714558 |
|
Email:
|
nicolas.abouchaar@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Ahmed A. BAdawy, MD |
|
Address:
|
|
|
Telephone:
|
+96597700293 |
|
Email:
|
dr.ahmedbadawy545@gmail.com |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- pediatric patients (2-6 years old), with an American society of Anesthegiologists
physical status (ASA) I-II who were undergoing strabismus surgery (for more than one
muscle)
Exclusion Criteria:
- failure to obtain consent, mental retardation or developmental delay, epilepsy,
psychiatric or neurological diseases that impair communication, current use of
gabapentin, psychotropic or opioids.
Age minimum:
2 Years
Age maximum:
6 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Emergence Agitation After Desflurane Anesthesia
|
|
Intervention(s)
|
|
Drug: Strawberry juice as (placebo)
|
|
Drug: Gabapentin Oral Solution [Neurontin]
|
|
Primary Outcome(s)
|
|
emergence agitation incidence and scores
[Time Frame: through study completion, an average of 1 year]
|
|
Secondary Outcome(s)
|
|
duration of emergence
[Time Frame: through study completion, an average of 1 year]
|
|
Secondary ID(s)
|
|
kuwaiteyecenter01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|