Analgesic Effect of IV Acetaminophen in Tonsillectomies
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Adenotonsillitis Tonsillitis |
Drug: Acetaminophen (paracetamol) Drug: Morphine (hydromorphone) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Analgesic Effect of Single Dose Intravenous Acetaminophen in Pediatric Patients Undergoing Tonsillectomy |
- Analgesic efficacy of single dose intravenous acetaminophen in pediatric patients undergoing tonsillectomy to measure opioid consumption and pain scores in the first 8-12 postoperative hours. [ Time Frame: 8-12 hours post-operatively ] [ Designated as safety issue: No ]
- To observe recovery characteristics in the PACU and floor in patients following tonsillectomy. [ Time Frame: 8-12 hours post-operatively ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IV Acetaminophen
Patients will receive pre-medication with oral midazolam Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction..
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Drug: Acetaminophen (paracetamol)
Acetaminophen IV (15 mg/kg) administered to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures. In addition, Morphine will be used in this arm to manage pain as in the placebo arm of the study.
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Placebo Comparator: Saline placebo infused intraoperatively
For this arm Morphine will be administered to manage pain.
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Drug: Morphine (hydromorphone)
Saline placebo will be infused intraoperatively, and morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
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Detailed Description:
Once enrolled, subjects will have a standardized anesthetic on the day of surgery:
- Pre-medication with oral midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction
- Inhalation induction with sevoflurane and a mixture of N20/02
- Propofol 1-1.5 mg/kg to facilitate endotracheal intubation
- Morphine 0.1 mg/kg given prior to intubation
- Maintenance anesthesia with isoflurane, titrated to 0.8-1 MAC with a mixture of Air/02
- Acetaminophen IV (15 mg/kg) vs. saline placebo infused intraoperatively (randomized by pharmacy)
- 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.
Eligibility| Ages Eligible for Study: | 2 Years to 9 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female patients aged 2 years and younger than 9 years old requiring postoperative admission for tonsillectomy or adenotonsillectomy.
- Functional status as assigned by the American Society of Anesthesiology (ASA) classification of I (1), II (2) or III (3).
- Have a parent/guardian who are able to provide written informed consent in accordance with HIC regulations.
- 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:
- Male or female patients age greater than 9 years.
- Have an American Society of Anesthesiologists Physical Status > IV (4)(severe disease that is life threatening).
- Have a known hypersensitivity or allergy to acetaminophen.
- Have a known allergy or intolerance to morphine or fentanyl.
- Have received chronic opioid analgesic therapy prior to surgery.
- Have renal disease.
- Have hepatic disease.
- Are morbidly obese (% BMI > 95).
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01691690
| United States, Ohio | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| Principal Investigator: | Arlyne Thung, MD | Nationwide Children's Hospital |
More Information
Publications:
| Responsible Party: | Arlyne Thung, Clinical Assistant Professor, Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01691690 History of Changes |
| Other Study ID Numbers: | IRB12-00097 |
| Study First Received: | May 30, 2012 |
| Last Updated: | May 10, 2016 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Tonsillitis Pharyngitis Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases Hydromorphone Morphine Acetaminophen |
Analgesics Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics, Non-Narcotic Antipyretics |
ClinicalTrials.gov processed this record on September 26, 2016