Oral tramadol pharmacokinetics in pediatric subjects versus adults—Is there a role of delayed gastric emptying in pediatric subjects?

Srinivas, Nuggehally R.

doi:10.1002/cpdd.230

Cited by 1 publication

(2 citation statements)

References 7 publications

(25 reference statements)

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“…Although research suggests that tramadol exhibits a measurable but smaller effect on gastrointestinal motility than that of conventional opioids such as codeine and morphine, care should be taken while administering higher doses. 14,23,24…”

Section: Discussionmentioning

confidence: 99%

“…In addition, the minor delaying effect of tramadol on gastric emptying should also be considered while designing the QT/QTc study. Although research suggests that tramadol exhibits a measurable but smaller effect on gastrointestinal motility than that of conventional opioids such as codeine and morphine, care should be taken while administering higher doses …”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Safety, Tolerability, and Pharmacokinetics of Therapeutic and Supratherapeutic Doses of Tramadol Hydrochloride in Healthy Adults: A Randomized, Double‐Blind, Placebo‐Controlled Multiple‐Ascending‐Dose Study

DeLemos

Richards

Vandenbossche

et al. 2017

Clinical Pharm in Drug Dev

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This randomized, double-blind, parallel-group multiple-ascending-dose study evaluated the safety, tolerability, and pharmacokinetics of tramadol hydrochloride in healthy adults to inform dosage and design for a subsequent QT/QTc study. Healthy men and women, 18 to 45 years old (inclusive), were sequentially assigned to the tramadol 200, 400, or 600 mg/day treatment cohort and within each cohort, randomized (4:1) to either tramadol or placebo every 6 hours for 9 oral doses. Of the 24 participants randomized to tramadol (n = 8/cohort), 22 (91.7%) completed the study. The AUC of tramadol increased approximately 2.2- and 3.6-fold for the (+) enantiomer and 2.0- and 3.5-fold for the (-) enantiomer with increasing dose from 200 to 400 and 600 mg/day, whereas the C increased 2.1- and 3.3-fold for the (+) enantiomer and 2.0- and 3.2-fold for the (-) enantiomer. Overall, 21 participants (87.5%) participants reported ≥1 treatment-emergent adverse event; most frequent were nausea (17 of 24, 70.8%) and vomiting (7 of 24, 29.2%). Vomiting (affected participants and events) increased with increasing dose from 200 to 600 mg/day but was mild (5 of 24) or moderate (2 of 24) in severity. All tested dosage regimens of tramadol showed acceptable safety and tolerability profile for further investigation in a thorough QT/QTc study.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%