Status:
WITHDRAWN
Effectiveness of Nitrous Oxide 50% for Reducing Pain and Distress Associated with Needle-stick in Children
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Linde AG
Conditions:
Local Anesthetic Efficacy
Eligibility:
All Genders
3-6 years
Phase:
NA
Brief Summary
Venipuncture (puncturing of a vein) through the skin in order to insert a vein catheter (also know as cannula) is one of the most common needle-related medical procedures performed in children. Venipu...
Detailed Description
This study was never conducted due to lack of funding
Eligibility Criteria
Inclusion
- • Children ages 3 to 6 years of age who require diagnostic CT or nuclear medicine studies under conscious sedation
- Guardians give consent and the child gives assent when appropriate
- Both genders
- All racial and ethnic groups
- English and other languages speaking and reading children and guardians (for consent/assent purposes)
Exclusion
- Age less than 3 or older than 6 years
- Patients who had a history of adverse events with facemask; mask phobia
- If parents/patients refuse to participate in the study
- Fasting less than 2h for clear liquids, 4h breast milk, 6h formula and fortified breast milk for under 1 yr and 8h for over 1yr, 8h for non-human milk and solid food.
- Impairment of cognition/neurologic, hepatic, renal, cardiovascular, endocrine, metabolic, and/or coagulation function.
- A history of any diagnosis of psychiatric disorders as reported by parents/guardians
- A history of chronic pain and/or use of chronic (daily around the clock) opioids, other analgesics or sedatives/hypnotics
- Intake of prescription medications or over-the-counter medications known to affect pain perception such as narcotics, non-steroidal anti-inflammatory agents, stimulants, hypnotics, sedatives, etc. within 8 hours of planned surgical procedure
- Vitamin B12 \& folate deficiency
- Immune suppression (e.g., postoperative organ transplant, chemotherapy, neutropenia, any condition suppresses immunity or bone marrow)
- Abnormal homocysteine metabolism
- Lung cyst, bowel obstruction, middle ear disease, pneumothorax, head injury, active gastro-esophageal reflux, history of delayed gastric emptying and vomiting, upper airway obstruction, airway infection, active wheezing from asthma, and apnea
- Significant impairments: pulmonary hypertensions, cardiomyopathy, hypovolemia, meningitis, space occupying lesions of the brain e.g. tumors, sepsis, severe liver diseases (e.g., biliary atresia, liver failure)
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03342079
Start Date
March 1 2014
End Date
December 1 2014
Last Update
March 11 2025
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