OBJECTIVE:Lumbar puncture (LP) is usually associated with anxiety and apprehension in children and their parents. This study was performed for controlling children's anxiety before and during LP and increasing the success of LP due to relaxation of the child following the use of sedative drugs and to compare the efficacy and side effects of oral midazolam and oral chloral hydrate. METHOD: This prospective randomized controlled clinical trial included 160 children aged 2-7 years, candidates for LP. They were divided into two randomized groups of 80 children each: group I received 80 mg/kg oral chloral hydrate and group II received 0.5 mg/kg oral midazolam before LP. RESULTS: The results indicated that the mean sedation grade was 3.8 +/- 1.0 in chloral hydrate group and 2.3 +/- 0.9 in midazolam group (P < 0.001). The mean onset of sedative effect was 30.9 +/- 8.8 min in midazolam group and 16.5 +/- 5.8 min in chloral hydrate group (P < 0.001). Prolonged sedation was the most common side effect in oral midazolam group (94.4%) versus 22.2% in chloral hydrate group. CONCLUSION: Based on the level of sedation, side effects, time to onset of sedation and recovery time from sedation, oral chloral hydrate is a better sedative medication than oral midazolam.
RCT Entities:
OBJECTIVE: Lumbar puncture (LP) is usually associated with anxiety and apprehension in children and their parents. This study was performed for controlling children's anxiety before and during LP and increasing the success of LP due to relaxation of the child following the use of sedative drugs and to compare the efficacy and side effects of oral midazolam and oral chloral hydrate. METHOD: This prospective randomized controlled clinical trial included 160 children aged 2-7 years, candidates for LP. They were divided into two randomized groups of 80 children each: group I received 80 mg/kg oral chloral hydrate and group II received 0.5 mg/kg oral midazolam before LP. RESULTS: The results indicated that the mean sedation grade was 3.8 +/- 1.0 in chloral hydrate group and 2.3 +/- 0.9 in midazolam group (P < 0.001). The mean onset of sedative effect was 30.9 +/- 8.8 min in midazolam group and 16.5 +/- 5.8 min in chloral hydrate group (P < 0.001). Prolonged sedation was the most common side effect in oral midazolam group (94.4%) versus 22.2% in chloral hydrate group. CONCLUSION: Based on the level of sedation, side effects, time to onset of sedation and recovery time from sedation, oral chloral hydrate is a better sedative medication than oral midazolam.
Authors: Andrew S J Marshall; Manish Sadarangani; Alexandra Scrivens; Rachel Williams; Jean Yong; Ursula Bowler; Louise Linsell; Virginia Chiocchia; Jennifer L Bell; Caz Stokes; Patricia Santhanadass; Eleri Adams; Edmund Juszczak; Charles C Roehr Journal: BMC Pediatr Date: 2020-04-15 Impact factor: 2.125