OBJECTIVE: The search for an effective post-tonsillectomy analgesic has been disappointing. This study tests the hypothesis that rofecoxib improves pain scores in children for 72 hours post-tonsillectomy when compared to hydrocodone with acetaminophen elixir. STUDY DESIGN: Prospective, randomized, double-blind, active comparison of postoperatively administered rofecoxib or hydrocodone with acetaminophen in 60 healthy children scheduled for elective tonsillectomy. SUBJECTS AND METHODS: Sixty ASA I and II children scheduled for elective tonsillectomy were enrolled to receive either rofecoxib or hydrocodone with acetaminophen, commencing at discharge from day surgery. Active and passive pain scores and side effects were assessed for 3 days. RESULTS AND CONCLUSION:Rofecoxib significantly reduced active pain scores at all time intervals after 6 hours following surgery when compared to hydrocodone with acetaminophen without detectable differences in adverse effects. This difference was not apparent in passive pain scores. A review of analgesic strategies is presented. Study results and review of the literature support the development of pediatric formulations of NSAIDs with greater COX-2 selectivity to improve postsurgical pain relief for children.
RCT Entities:
OBJECTIVE: The search for an effective post-tonsillectomy analgesic has been disappointing. This study tests the hypothesis that rofecoxib improves pain scores in children for 72 hours post-tonsillectomy when compared to hydrocodone with acetaminophen elixir. STUDY DESIGN: Prospective, randomized, double-blind, active comparison of postoperatively administered rofecoxib or hydrocodone with acetaminophen in 60 healthy children scheduled for elective tonsillectomy. SUBJECTS AND METHODS: Sixty ASA I and II children scheduled for elective tonsillectomy were enrolled to receive either rofecoxib or hydrocodone with acetaminophen, commencing at discharge from day surgery. Active and passive pain scores and side effects were assessed for 3 days. RESULTS AND CONCLUSION:Rofecoxib significantly reduced active pain scores at all time intervals after 6 hours following surgery when compared to hydrocodone with acetaminophen without detectable differences in adverse effects. This difference was not apparent in passive pain scores. A review of analgesic strategies is presented. Study results and review of the literature support the development of pediatric formulations of NSAIDs with greater COX-2 selectivity to improve postsurgical pain relief for children.
Authors: Kimberly A Sutters; Danielle Holdridge-Zeuner; Steven Waite; Steven M Paul; Marilyn C Savedra; Brent Lanier; Karla Mahoney; Christine Miaskowski Journal: Pain Med Date: 2012-02-07 Impact factor: 3.750
Authors: Y Walrave; C Maschi; S Bailleux; A T Falk; C Hayem; M Carles; F De la Brière Journal: Eur Arch Otorhinolaryngol Date: 2017-10-27 Impact factor: 2.503
Authors: Kimberly A Sutters; Christine Miaskowski; Danielle Holdridge-Zeuner; Steven Waite; Steven M Paul; Marilyn C Savedra; Brent Lanier; Karla Mahoney Journal: Clin J Pain Date: 2010-02 Impact factor: 3.442
Authors: Montasir Junaid; Muhammad Sohail Halim; Maisam Abbas Shiraz Onali; Sadaf Qadeer; Hareem Usman Khan; Naeem Sultan Ali Journal: Int Arch Otorhinolaryngol Date: 2019-11-04