Page 112 WHO - Guidelines on the pharmacological treatment of persisting pain in children with medical illness

GRADE Table 4

Author: Wiffen PJ A1
Date: 16-04-2009
Question: Should oral transmucosal fentanyl citrate vs. intravenous morphine be used for extremity
injury or suspected fracture in children aged 8–18 years?
Setting: Pediatric tertiary care emergency department. Denver, CO, USA.
Bibliography: Mahar P et al. A randomised clinical trial of oral transmucosal fentanyl citrate vs
intravenous morphine sulfate for initial control of pain in children with extremity injuries. Pediatric
Emergency Care, 2007, 23:544–548.
A2
Summary of findings
Quality assessment No. of
patients Effect

No. of studies Design Limitations Inconsistency Indirectness Imprecision Other considerations Oral transmucosal fentanyl IV morphine Relative (95% CI) Absolute Quality A3

Reduction in VAS pain intensity (follow-up: 75 minutes) a
1 Rand- Serious c No Serious d No None 50 ITT 45 ITT Not – LOW
omized serious serious calcu- A4 A4
trial inconsist- impreci- lated b
ency sion
Adverse events (follow-up mean 75 minutes)
1 Rand- Serious c No Serious d No None 8 ad- 2 ad- – – LOW
omized serious serious verse verse
trial inconsist- impreci- events events
ency sion
IV, intravenous; CI, confidence interval; ITT, intention to treat. A5
a Intervention is transmucosal fentanyl 10–15 mcg/kg; control is IV morphine 0.1mg/kg.
b Reduction in VAS pain intensity greater than 40 mm in morphine IV group and greater than 60 mm in oral
transmucosal fentanyl.
c Open study, not blinded.
d Study in acute pain not cancer pain.
A6

A7

109 <