Safety and Pharmacokinetic Study of Intravenous Acetaminophen Administration in Pediatric Inpatients
Summary
We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called pharmacokinetics) is an important step in learning what the best dose of acetaminophen for children should be. We are also interested in learning about the safety of this medication when given to children.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Pain
Intervention
IV Acetaminophen
Location
Lucile Packard Children's Hospital
Stanford
California
United States
94305
Status
Completed
Source
Cadence Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00493246
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pain, Referred
A type of pain that is perceived in an area away from the site where the pain arises, such as facial pain caused by lesion of the VAGUS NERVE, or throat problem generating referred pain in the ear.
Facial Pain
Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES.
Acetaminophen
Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
Pregnenolone Carbonitrile
A catatoxic steroid and microsomal enzyme inducer having significant effects on the induction of cytochrome P450. It has also demonstrated the potential for protective capability against acetaminophen-induced liver damage.
Complex Regional Pain Syndromes
Conditions characterized by pain involving an extremity or other body region, HYPERESTHESIA, and localized autonomic dysfunction following injury to soft tissue or nerve. The pain is usually associated with ERYTHEMA; SKIN TEMPERATURE changes, abnormal sudomotor activity (i.e., changes in sweating due to altered sympathetic innervation) or edema. The degree of pain and other manifestations is out of proportion to that expected from the inciting event. Two subtypes of this condition have been described: type I; (REFLEX SYMPATHETIC DYSTROPHY) and type II; (CAUSALGIA). (From Pain 1995 Oct;63(1):127-33)
Clinical Trials
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Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
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PubMed Articles
The role of intravenous acetaminophen in acute pain management: a case-illustrated review.
For more than a century, acetaminophen has been recognized worldwide as a safe and effective agent for relieving pain and reducing fever in a wide range of patients. However, until recently, acetamino...
Good surgical outcomes depend in part on good pain relief, allowing for early mobilization, optimal recovery, and patient satisfaction. Postsurgical pain has multiple mechanisms, and multimechanis...
BACKGROUND: Withdrawal movement during rocuronium injection is a common, unresolved adverse effect. We aimed to investigate the effect of IV acetaminophen pretreatment on withdrawal movement during ro...
The effects of preoperative intravenous acetaminophen in patients undergoing abdominal hysterectomy.
PURPOSE: Although intravenous acetaminophen is commonly used for the management of postoperative pain, very limited evidence supports the usefulness of preoperative administration. The aim of this stu...
