N. Bahalomara et al., SEDATION WITH MEPERIDINE AND MIDAZOLAM IN PEDIATRIC-PATIENTS UNDERGOING ENDOSCOPY, European Journal of Clinical Pharmacology, 47(4), 1994, pp. 319-323
We conducted a randomized, double-blind trial evaluating the efficacy
and safety of meperidine 2 mg.kg(-1) (M) and meperidine 2 mg.kg(-1) pl
us midazolam 0.05 mg.kg(-1) (M + M) in 40 pediatric outpatients (age 1
to 17 years) undergoing upper endoscopy procedures. The physician and
nurse performing the procedure were asked to rate cooperation, emotio
nal status, drowsiness, and overall efficacy. A blinded observer recor
ded the frequency of negative behaviors indicating distress, vital sig
ns, and oxygen saturation before, during, and after the procedure. No
significant differences were noted in the overall efficacy of the regi
mens. Good or excellent efficacy was noted in 15 of 21 children (71 %)
in the M group and 15 of 19 children (79 %) in the M + M group by phy
sicians; nurses assigned a good or excellent rating for 14 of 21 (67 %
) and 13 of 19 (68 %) in the M and M + M groups, respectively. Immedia
tely following the procedure, amnesia was noted in 4 of 17 (23 %) pati
ents who received M versus 14 of 18 (78 %) patients who received M + M
(P = 0.002). Of the children who received M + M, the amnesia tended t
o occur more frequently in older children (> 11 years, 8 children, rat
e of amnesia 100 %) than in younger children (less than or equal to 11
years, 6 of 10 evaluable children, rate of amnesia 60 %). There was n
o significant difference between the frequency of negative behaviors,
rate of adverse effects, or changes in vital signs or oxygen saturatio
n noted with the two drug regimens. We conclude that although the two
sedation regimens produced similar efficacy, the combination of M + M
may be preferred over M alone to enhance amnesia. Additional trials of
M + M for sedation prior to other procedures are needed.