Airway Obstruction Clinical Trial
Official title:
Efficacy of IV vs Oral Administration of Acetaminophen for Pain Control Following Tonsillectomy With or Without Adenoidectomy
Verified date | June 2017 |
Source | William Beaumont Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.
Status | Completed |
Enrollment | 41 |
Est. completion date | January 2015 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 13 Years |
Eligibility |
Inclusion Criteria: - Children 5-13 years of age - Surgical procedure: tonsillectomy with or without adenoidectomy - American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness or mild systemic disease that is well-controlled, e.g. mild asthma) Exclusion Criteria: - Known allergy to study medication(s) - Known genetic abnormality - Known hepatitis - Children with other physical, mental or medical conditions which, in the opinion of the PI, make study participation inadvisable or impairs pain assessment - Children who have taken any analgesic within 24 hours prior to surgery - Enrollment in concurrent research study - Pregnant patients* - Students/trainees/staff* - Mentally disabled/cognitively impaired* |
Country | Name | City | State |
---|---|---|---|
United States | Beaumont Health System | Royal Oak | Michigan |
Lead Sponsor | Collaborator |
---|---|
Kaveh Aslani, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Pain Medication | All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents. | From time of PACU admission until 24 hours post-operatively. | |
Secondary | FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores | FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures each of 5 pain behaviors on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU. | At time of admission into PACU. | |
Secondary | Incidence of Post-operative Vomiting | Percentage of subjects with at least one episode of post-operative vomiting | From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants. | |
Secondary | Parental Satisfaction With Pain Control. | Parental satisfaction with pain control, as measured on a 10 point Likert scale where 1= Extremely dissatisfied and 10= Extremely satisfied. Data gathered through phone call to parents 24 hours post hospital discharge. | 24 hours post hospital discharge. |
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