Oral Morphine versus Rectal Ketamine in Pain Management during Burn Wound Dressing: An Open Label Randomized Clinical Trial

Abstract

Background: Oral morphine has been widely used to manage children’s pain during burn wound dressing. Rectal ketamine may also be safely administered to children. Objective: To evaluate and compare the efficacy of oral morphine vs. rectal racemic ketamine in management of pain during burn wound dressing in a pediatric population in a rural study population. Methods: This was a randomized open-label clinical trial done in a rural hospital in Uganda. Study participants were randomly assigned to one of the treatment groups, either oral morphine or rectal ketamine, with a ratio of 1:1. Overall, we enrolled 44 participants, with 22 in each treatment arm. Assessment of baseline vital signs, including pulse rate, blood pressure, respiratory rate, temperature, oxygen saturation (SPO2), pain assessment (using Face Legs Activity Cry Consolability [FLACC]), and sedation scores (using Richmond’s agitation and sedation scale [RASS]) among others was done. Study participants were followed up hourly for 8 hours for outcomes of interest: adequate pain management/adverse events. Results: The mean age of the study participants was 2.56 (±1.59) years. The overall mean intra-procedural pain difference score for children who received oral morphine was 2.7 (SD±2.2) compared to 0 (SD±0) among those who received rectal ketamine, and the mean difference of 2.7 was statistically significant (p < 0.0001). Sialorrhea (hyper-salivation) was the only significant adverse event, with more occurrence in the rectal Ketamine treatment arm (n= 8, 36.3%) compared to 1 (5%) in the oral Morphine treatment arm, p = 0.009. There were no significant adverse effects noted in either treatment arm. Conclusion: The study showed the non-inferiority of rectal ketamine over oral morphine and concluded that administration of rectal ketamine was better at pain management and safety compared to oral morphine. Rectal ketamine is associated with an increased incidence of sialorrhea compared to oral morphine.