An evaluation of the efficacy and tolerability of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children.
In this double-blinded, randomized, multicenter study, we examined analgesic efficacy and tolerability of tramadol in postoperative pediatric patients. Eighty-one postsurgical ASA physical status I and II patients ages 7-16 yr received oral tramadol (approximately 1 or 2 mg/kg) for postoperative analgesia when they were ready to transition from morphine patient-controlled analgesia to oral analgesics. Rescue analgesia consisted of morphine patient-controlled analgesia or an oral equivalent dose of oxycodone. Patients rated their pain just before the administration of tramadol and at regular intervals for 8 h afterwards using the Wong-Baker Faces Pain Rating Scale. The 2-mg/kg group required approximately half as much rescue analgesia as the 1-mg/kg group (P = 0.006). Parents rated the larger dose more favorably. Adverse events were generally mild to moderate in severity (vomiting [10%], nausea [9%], pruritus [7%], rash [4%]) and similar between the two treatment groups. There were no significant changes in hemodynamic variables, respiratory rate, or SpO(2) percentages between the two treatment groups or in all patients compared with pretreatment values.


CONCLUSIONS
Oral tramadol 1-2 mg/kg is well tolerated and effective in postoperative children ready to transition from morphine patient-controlled analgesia. The group receiving 2 mg/kg required less rescue analgesic compared with those receiving 1 mg/kg.
Finkel
Julia C
JC
Department of Anesthesiology, Children's National Medical Center, George Washington University, 111 Michigan Avenue NW, Washington, DC 20010, USA. jfinkel@cnmc.org
Rose
John B
JB
Schmitz
Michael L
ML
Birmingham
Patrick K
PK
Ulma
George A
GA
Gunter
Joel B
JB
Cnaan
Avital
A
Coté
Charles J
CJ
Medve
Robert A
RA
Schreiner
Mark S
MS
D000293:Adolescent; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009020:Morphine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D010147:Pain Measurement / Q000187:drug effects; D010149:Postoperative Pain / Q000188:drug therapy*; D015656:Respiratory Mechanics / Q000187:drug effects; D013607:Tablets; D014147:Tramadol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000701:Analgesics, Opioid; D013607:Tablets; D014147:Tramadol; D009020:Morphine