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The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.
Tonsillectomy with or without adenoidectomy is a common surgical procedure in children and adolescents. Usually performed for recurrent tonsillitis or symptoms of airway obstruction, the procedure can result in significant post-operative pain. Common analgesic techniques include the use of oral acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen by mouth (PO) or ketorolac intravenous (IV), and narcotics. Acetaminophen has been shown to be effective in reducing pain and post-operative opioid requirements. Its administration can be oral, rectal, or intravenous. NSAIDs, though effective for pain control, have been shown to increase bleeding risk and disrupt hemostasis. Narcotics are effective for pain control but increase the risk of nausea and vomiting. They also have the potential to cause respiratory depression.
IV acetaminophen (OFIRMEV) is indicated for management of mild to moderate pain, and as an adjunct to opioids for severe pain. Several studies have examined the efficacy of IV acetaminophen vs placebo and/or active controls (meperidine, rectal acetaminophen (PR), tramadol). IV acetaminophen has been shown to be superior to placebo for pain control. Though there is data regarding peak plasma and Cerebral Spinal Fluid (CSF) concentration of acetaminophen when given by different routes (PO vs IV vs PR), there is no data comparing the efficacy of oral vs IV administration for pain control post-tonsillectomy in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion. |
|
| Control Group | Active Comparator | PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV acetaminophen | Drug | IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR . |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaveh Aslani, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Health System | Royal Oak | Michigan | 48073 | United States |
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Participants were enrolled over a period of 23 months in the pre-operative setting of an out-patient surgical unit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion. IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only. |
| FG001 | Control Group | PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area. PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline participant number does not include 2 patients removed from study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion. IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Pain Medication | All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents. | Only patients receiving rescue pain medication were analyzed. | Posted | Median | Inter-Quartile Range | mg | From time of PACU admission until 24 hours post-operatively. |
|
Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion. IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Nervous system disorders | Non-systematic Assessment |
The number of participants in both groups are very small. Data in pain scores outcome was skewed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kaveh Aslani, MD | Beaumont Hsopital | 248-898-1907 | kaveh.aslani@beaumont.org |
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| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D000402 | Airway Obstruction |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| PO acetaminophen | Drug | PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area. |
|
|
| At time of admission into PACU. |
| 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. |
| 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. |
PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area. PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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. | Posted | Median | Full Range | units on a scale | At time of admission into PACU. |
|
|
|
| Secondary | Incidence of Post-operative Vomiting | Percentage of subjects with at least one episode of post-operative vomiting | Posted | Count of Participants | Participants | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 24 hours post hospital discharge. |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 4 |
| 20 |
| EG001 | Control Group | PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area. PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area. | 0 | 19 | 1 | 19 | 6 | 19 |
| vomit x1 | Gastrointestinal disorders | Non-systematic Assessment |
|
| vomit x2 | Gastrointestinal disorders | Non-systematic Assessment |
|
| vomit x3 | Gastrointestinal disorders | Non-systematic Assessment |
|
| PACU delirium | Nervous system disorders | Non-systematic Assessment |
|
| poss. airway swelling | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| coughing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| stridor | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| Aniline Compounds |
| D000588 | Amines |