Analgesic Effect of IV Acetaminophen in Tonsillectomies
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 2 - 9 |
| Updated: | 5/12/2016 |
| Start Date: | October 2012 |
| End Date: | May 2016 |
Analgesic Effect of Single Dose Intravenous Acetaminophen in Pediatric Patients Undergoing Tonsillectomy
Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate
pain for pediatric patients. Its common use (particularly in oral form) is underscored by
its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse
systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses.
Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated,
these mechanisms appear to be multi-factorial and include central inhibition of the
cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from
arachidonic acid, interference with serotonergic descending pain pathways, indirect
activation of cannabinoid CB1 receptors and inhibition of nitric oxide pathways through
N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known
is that of central inhibition of COX enzymes by which the decreased production of
prostaglandins diminish the release of excitatory transmitters of substance P and glutamate
which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011).
To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric
population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et
al, 2009; Hong et al, 2010).
pain for pediatric patients. Its common use (particularly in oral form) is underscored by
its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse
systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses.
Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated,
these mechanisms appear to be multi-factorial and include central inhibition of the
cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from
arachidonic acid, interference with serotonergic descending pain pathways, indirect
activation of cannabinoid CB1 receptors and inhibition of nitric oxide pathways through
N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known
is that of central inhibition of COX enzymes by which the decreased production of
prostaglandins diminish the release of excitatory transmitters of substance P and glutamate
which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011).
To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric
population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et
al, 2009; Hong et al, 2010).
Once enrolled, subjects will have a standardized anesthetic on the day of surgery:
1. Pre-medication with oral midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20
minutes before induction
2. Inhalation induction with sevoflurane and a mixture of N20/02
3. Propofol 1-1.5 mg/kg to facilitate endotracheal intubation
4. Morphine 0.1 mg/kg given prior to intubation
5. Maintenance anesthesia with isoflurane, titrated to 0.8-1 MAC with a mixture of Air/02
6. Acetaminophen IV (15 mg/kg) vs. saline placebo infused intraoperatively (randomized by
pharmacy)
7. Ondansetron (0.15 mg/kg, maximum dose of 4 mg) and dexamethasone (0.25 mg/kg, maximum
dose of 20 mg) for postoperative nausea prophylaxis.
Following surgery and extubation, baseline vitals will be obtained and pain scores will be
assessed in the post anesthesia care unit (PACU) via FLACC (Faces, Legs, Activity, Cry,
Consolability Scale).The presence of emergence delirium will be assessed via PAED (Pediatric
Agitation and Emergence Delirium scale). Those subjects whose pain score is assessed at < 4
will receive standard postoperative care and no analgesics. Assessed pain scores > 4 will
receive 0.5mcg/kg fentanyl q10 minutes as needed. Variables such as time to extubation in
the PACU, time to first analgesic delivery, pain scores, # times/total dose of opioids
given, presence of sedation, nausea/vomiting, duration of oxygen requirement in PACU,
whether or not patient was discharged to floor on oxygen and total PACU time will be
recorded during the duration of the patient's PACU stay. Subjects will be discharged to the
inpatient floor from the PACU once standard discharge criteria have been met.
Following discharge from the PACU, standardized analgesics will be given for breakthrough
pain (oral oxycodone 0.1mg/kg q4hrs PRN pain). Enrolled patients will be followed during the
duration of their inpatient stay. Duration of oxygen requirement on the floor, pain scores
and number of administered oxycodone doses on the floor will be monitored and recorded.
1. Pre-medication with oral midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20
minutes before induction
2. Inhalation induction with sevoflurane and a mixture of N20/02
3. Propofol 1-1.5 mg/kg to facilitate endotracheal intubation
4. Morphine 0.1 mg/kg given prior to intubation
5. Maintenance anesthesia with isoflurane, titrated to 0.8-1 MAC with a mixture of Air/02
6. Acetaminophen IV (15 mg/kg) vs. saline placebo infused intraoperatively (randomized by
pharmacy)
7. Ondansetron (0.15 mg/kg, maximum dose of 4 mg) and dexamethasone (0.25 mg/kg, maximum
dose of 20 mg) for postoperative nausea prophylaxis.
Following surgery and extubation, baseline vitals will be obtained and pain scores will be
assessed in the post anesthesia care unit (PACU) via FLACC (Faces, Legs, Activity, Cry,
Consolability Scale).The presence of emergence delirium will be assessed via PAED (Pediatric
Agitation and Emergence Delirium scale). Those subjects whose pain score is assessed at < 4
will receive standard postoperative care and no analgesics. Assessed pain scores > 4 will
receive 0.5mcg/kg fentanyl q10 minutes as needed. Variables such as time to extubation in
the PACU, time to first analgesic delivery, pain scores, # times/total dose of opioids
given, presence of sedation, nausea/vomiting, duration of oxygen requirement in PACU,
whether or not patient was discharged to floor on oxygen and total PACU time will be
recorded during the duration of the patient's PACU stay. Subjects will be discharged to the
inpatient floor from the PACU once standard discharge criteria have been met.
Following discharge from the PACU, standardized analgesics will be given for breakthrough
pain (oral oxycodone 0.1mg/kg q4hrs PRN pain). Enrolled patients will be followed during the
duration of their inpatient stay. Duration of oxygen requirement on the floor, pain scores
and number of administered oxycodone doses on the floor will be monitored and recorded.
Inclusion Criteria:
1. Male or female patients aged 2 years and younger than 9 years old requiring
postoperative admission for tonsillectomy or adenotonsillectomy.
2. Functional status as assigned by the American Society of Anesthesiology (ASA)
classification of I (1), II (2) or III (3).
3. Have a parent/guardian who are able to provide written informed consent in accordance
with HIC regulations.
4. Have parent/guardian who are compliant with routine medical care, capable of
subjective evaluation and able to read, understand and sign the informed consent.
Exclusion Criteria:
1. Male or female patients age greater than 9 years.
2. Have an American Society of Anesthesiologists Physical Status > IV (4)(severe disease
that is life threatening).
3. Have a known hypersensitivity or allergy to acetaminophen.
4. Have a known allergy or intolerance to morphine or fentanyl.
5. Have received chronic opioid analgesic therapy prior to surgery.
6. Have renal disease.
7. Have hepatic disease.
8. Are morbidly obese (% BMI > 95).
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