Tonsillitis, Airway Obstruction, Difficulty Swallowing
Conditions
Keywords
tonsillitis, recurrent tonsillitis, obstructed air passages, swallowing difficulties
Brief summary
The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.
Detailed description
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.
Interventions
DRUGIV acetaminophen
IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR .
DRUGPO 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.
Sponsors
Kaveh Aslani, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
No
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\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Pain Medication | From time of PACU admission until 24 hours post-operatively. | All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores | At time of admission into PACU. | 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. |
| Incidence 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. | Percentage of subjects with at least one episode of post-operative vomiting |
| Parental Satisfaction With Pain Control. | 24 hours post hospital discharge. | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled over a period of 23 months in the pre-operative setting of an out-patient surgical unit.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Study Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 19 Participants | 39 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 4 / 20 | 6 / 19 |
| serious Total, serious adverse events | 0 / 20 | 1 / 19 |
Outcome results
Primary
Total Pain Medication
All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.
Time frame: From time of PACU admission until 24 hours post-operatively.
Population: Only patients receiving rescue pain medication were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Group | Total Pain Medication | 1.7 mg |
| Control Group | Total Pain Medication | 2.2 mg |
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.
Time frame: At time of admission into PACU.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Group | FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores | 0 units on a scale |
| Control Group | FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores | 0 units on a scale |
Secondary
Incidence of Post-operative Vomiting
Percentage of subjects with at least one episode of post-operative vomiting
Time frame: From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Incidence of Post-operative Vomiting | 1 Participants |
| Control Group | Incidence of Post-operative Vomiting | 3 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.
Time frame: 24 hours post hospital discharge.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Group | Parental Satisfaction With Pain Control. | 9 units on a scale |
| Control Group | Parental Satisfaction With Pain Control. | 8 units on a scale |