A double-blind, randomised, placebo-controlled trial of oral midazolam plus oral
ketamine for sedation of children during laceration repair.
Author(s): Barkan S(1), Breitbart R(2), Brenner-Zada G(1), Feldon M(1), Assa A(1), Toledano
M(3), Berkovitch S(3), Shavit I(4), Kozer E(2).
Affiliation(s): Author information:
(1)Pediatric Emergency Unit, Assaf Harofeh Medical Center, Zerifin, Israel.
(2)Pediatric Emergency Unit, Assaf Harofeh Medical Center, Zerifin, Israel
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. (3)Department
of Pharmacy, Assaf Harofeh Medical Center, Zerifin, Israel. (4)Department of
Pediatric Emergency, Rambam Health Care Campus, Haifa, Israel.
Publication date & source: 2014, Emerg Med J. , 31(8):649-53
OBJECTIVES: To compare the efficacy of oral midazolam alone with a combination of
oral midazolam and ketamine in children requiring laceration repair.
DESIGN: A randomised, double-blind, placebo-controlled study.
SETTING: Paediatric emergency department.
PARTICIPANTS: Children 1-10 years of age with lacerations requiring sedation.
INTERVENTIONS: Using a computer-generated sequence, children were randomly
assigned in blocks of four to one of two groups: oral midazolam (0.5 mg/kg) plus
oral placebo and oral midazolam (0.5 mg/kg) plus oral ketamine (5 mg/kg). The
allocation sequence was kept by the pharmacy staff, and the investigators were
blinded to randomisation until statistical analysis of the study was completed.
MAIN OUTCOME MEASURES: Visual Analogue Scale (VAS) assessment by a parent and
Sedation Score assessment by an investigator.
RESULTS: 60 children were recruited; 29 were assigned for treatment with
midazolam and 31 for the combination of midazolam and ketamine. There were no
differences in basic demographics and wound characteristics between the groups.
VAS assessment by a parent was 4.5±3.3 mm in the midazolam+ketamine group versus
4.4±2.7 mm in the midazolam alone group (mean difference 0.1, CI -1.9 to 1.71).
Sedation Score during procedure was lower in the midazolam+ketamine group (mean
difference 1.14, 95% CI 0.67 to 1.6). Intravenous sedation was required in two
(6%) of the children in the midazolam+ketamine group, and in eight (27%) in the
midazolam alone group. p=0.039. No clinically significant adverse effects were
documented in either group.
CONCLUSIONS: No difference was found in pain assessment during local anaesthetic
injection between the group treated with midazolam and ketamine, and the group
treated with midazolam alone. The combination of oral midazolam and ketamine led
to deeper sedation than midazolam alone, with less children requiring intravenous
sedation.
CLINICAL TRIAL REGISTRATION: The trial was registered in www.clinicaltrials.gov
as NCT01470157.
|