BACKGROUND: This study compared onset of sedation and satisfaction with two needleless jet injectors with the oral route for the administration of midazolam. METHODS:Forty-five children ages1-6 years were randomly assigned to receive either 0.5 mg kg(-1) oral midazolam, 0.2 mg kg(-1) subcutaneous midazolam by J-Tip injector or 0.2 mg kg(-1) intramuscular midazolam by Bioject injector. After midazolam administration the children were monitored for oxygen saturation, heart rate and level of sedation (0, alert; 1, calm; 2, drowsy; 3, dozing; 4, asleep) every 2 min for 20 min by a physician blinded to the route of administration. Patient satisfaction, resistance to treatment, success of delivery, problems with separation, and acceptance of mask at the time of induction were evaluated after midazolam treatment. RESULTS: The Bioject showed a faster onset of sedation than either the J-Tip injector or the oral midazolam (P < 0.05). The children were significantly less satisfied with the Bioject and J-Tip administration vs oral midazolam (P < 0.05). There were no differences in resistance, success of delivery, problems with separation, mask acceptance, arterial oxygen saturation or heart rate. CONCLUSION: Despite children being less satisfied with Bioject injection of midazolam, the procedure is safe, effective and provides a more rapid onset of preoperative sedation in children than either the J-Tip injection or oral route.
RCT Entities:
BACKGROUND: This study compared onset of sedation and satisfaction with two needleless jet injectors with the oral route for the administration of midazolam. METHODS: Forty-five children ages 1-6 years were randomly assigned to receive either 0.5 mg kg(-1) oral midazolam, 0.2 mg kg(-1) subcutaneous midazolam by J-Tip injector or 0.2 mg kg(-1) intramuscular midazolam by Bioject injector. After midazolam administration the children were monitored for oxygen saturation, heart rate and level of sedation (0, alert; 1, calm; 2, drowsy; 3, dozing; 4, asleep) every 2 min for 20 min by a physician blinded to the route of administration. Patient satisfaction, resistance to treatment, success of delivery, problems with separation, and acceptance of mask at the time of induction were evaluated after midazolam treatment. RESULTS: The Bioject showed a faster onset of sedation than either the J-Tip injector or the oral midazolam (P < 0.05). The children were significantly less satisfied with the Bioject and J-Tip administration vs oral midazolam (P < 0.05). There were no differences in resistance, success of delivery, problems with separation, mask acceptance, arterial oxygen saturation or heart rate. CONCLUSION: Despite children being less satisfied with Bioject injection of midazolam, the procedure is safe, effective and provides a more rapid onset of preoperative sedation in children than either the J-Tip injection or oral route.