ABSTRACT

Bone marrow aspiration and lumbar puncture play essential roles in the diagnosis and treatment of haematological disorders. These repeated invasive procedures lead to considerable pain and stress in children, which is emotionally stressful for their parents. This study aimed to compare the effectiveness and outcomes of two combinations of midazolam-ketamine (MK) and propofol-sufentanil (PS) in painful procedures of children with haematologic malignancy.

In this prospective, randomised, double-blind clinical trial, we enrolled 80 eligible patients with haematologic malignancy aged 2–14 years. We randomly allocated them to the MK and PS groups. We recorded and compared the level of sedation, pain severity, hemodynamic indices, the onset of effect, duration of recovery and complications during and after procedure in the two groups. We analysed the data using the SPSS software. We used Mann–Whitney U, independent t-test, chi-square and Fisher’s exact tests to compare continuous and categorical variables.

From initially enrolled patients, 68 patients completed the study (38 in PS and 30 in MK group). The levels of sedation and the mean score of pain intensity were significantly lower in the MK group than those in the PS group (p<0.05). Movements and the needs to repeat the dose were significantly lower in the MK group than those in the PS group (p<0.05).

During bone marrow aspiration and lumbar puncture procedures in children with haematologic malignancy, the findings of this trial suggest that MK combination therapy provides better sedation and analgesia than PS.

Keywords: Haematologic malignancy, ketamine, midazolam, propofol, sufentanil