Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01707420
Eligibility Criteria:
Inclusion Criteria:
* scheduled for outpatient tonsillectomy and adenoidectomy
* \< 60 Kg, between 5th and 95th percentile for weight
* ability to self-report pain
* complete pain diary with assistance from parent or guardian
Exclusion Criteria:
* require pre-anesthesia medication for anxiety
* require interpreter for verbal or written communication
* Obstructive sleep apnea significant enough to not qualify for outpatient surgery per surgeon
* ongoing oxygen dependence, pulmonary hypertension
* elevated risk of regurgitation
* history of seizures
* currently taking psychoactive medications or having a psychiatric condition requiring medications
* chronic pain disorders requiring medications
* renal disease
* developmental or cognitive disabilities
* history of adverse reactions to components of liquid gabapentin or placebo
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
16 Years
Study:
NCT01707420
Study Brief:
Protocol Section:
NCT01707420