Abstract
Objective : Children with hematological diseases (especiallly with leukemias) often undergo painfull procedures that adds more stress to their underlying illness. The aim of this study was to investigate whether oral midazolam can decrease fear and distress when given together with usual intravenous sedoanalgesia. Methods: A total of 47 patients with 1- 18 years of age who were followed at hematology inpatient setting were included in the study. The study group consisted of patients undergoing bone marrow aspiration or lumbar puncture for acute lymphoblastic leukemia (ALL) , acute myeloblastic leukemia (AML) ,immune thrombocytopenic purpura ( ITP) , thrombocytosis, chronic myeloid leukemia (CML) and aplastic anemia. Patients were divided into placebo (n=23) and oral midazolam (n=24) groups in this double-blind randomized study. Midazolam group received 0.1 mg/kg(maximum 10 mg) orally 30 minutes before the procedure. Both groups were administered 0.5mg/kg ketamine intravenously before the procedure. Parents and children>7 years reported their fear and distress with visual analogous scale(VAS) and Wong-Baker Fascies Scale. CHEOPS score was filled by the blinded pediatric hematologist performing the procedures. Results: There was no difference of fear and distress levels of placebo and midazolam groups according to VAS ,Wong Baker Fascies and CHEOPS scores(p>0.05). We found no additional effect in decreasing pain and stress of oral midazolam versus placebo when administered together with intravenous ketamineanalgesia. Nausea according to analgesia was found to be more reduced in the midazolam group (p< 0.05). Conclusion: Low dose oral midazolam does not have an additional effect in decreasing fear and distress in pediatric hematology patients when administered together with intravenous ketamineanalgesia. More studies to evaluate its effect when used without intravenous analgesia is warranted.
Highlights
The procedures included 52.2% (n=12) lumbar punctures and 47.8% (n=11) bone marrow aspirations in placebo group and 45.8% (n=11) lumbar punctures and 54.2% (n=13) bone marrow aspirations in midazolam group
Distress, pain, difficulty in taking the drug was found similar in midazolam and placebo groups according to VAS score (p>0.05)
The incidence of nausea was less in midazolam group when compared to placebo group (p=0.018)
Summary
Written informed consents were obtained from parents of all children. Procedure and evaluation The parents and children >5 years were given information about the study and were asked for their consent. Children were randomly assigned to two groups with computer generated random number chart by one of the study investigators (HK) according totwo batch series containing either oral midazolam (0.1 mg/kg at a maximum dose of 10 mg) mixed with orange juice or orange juice alone. Investigator performing the procedures (FBB), children and parents were blinded to the treatment allocation until statistical data analysis was completed. Nasal O2 2L/min was administered to all children Both groups received 0.5 mg/kg ketamine intravenously before the procedure. Two hours after the procedure, parents and children>7 years reported their fear, and distress with visual analogous scale(VAS) and Wong-Baker Facies Scale.
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