Low-Dose Intravenous Ketamine Bolus Versus Conventional Technique

• Status: Unknown status
• Trial end date: 2018-05-14
• Target enrollment: 0
• Participant gender: All

Summary

Abstract Background: Ketamine has been introduced as one of the most common drugs, administered to sedate children for different painful procedures in the emergency department (ED) but administration in higher dosage causes some severe complications. Thus, the aim of this study was to evaluate the effect of low-dose intravenous ketamine bolus versus conventional injection for reduction of upper and lower extremity fractures in children.

Materials and Methods: In this randomized clinical trial, 198 participants with upper and lower extremity fractures were enrolled. The participants were divided randomly into two groups. In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds. Then outcomes such as sedation depth and complications were measured for every two minutes and satisfaction of participants and physicians were recorded.

Results: Results showed that the successful sedation rate in the low dose ketamine group was significantly lower, as compared to the control group (7% vs 100%) (p<0.001). Moreover, In terms of duration of drug effect and of recovery, the low dose ketamine group were significantly lower compared with the group receiving higher dosage of ketamine (p<0.05). Furthermore, the sedation depth based on Wisconsin Sedation Scale was significantly higher, in the low dose ketamine group compared to the other group. By evaluating different complications, we found that the rate of neurological (20.4 % vs 5%) and physiological (10.2% vs 2%) complications in the control group was significantly higher compared to the group receiving low-dose ketamine (p<0.05).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Isfahan University of Medical Sciences
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• Parents' desire and consent to participate in the study

• Body mass index (BMI) within the normal range

• Having age of 6 months to 17 years

• Requiring a reduction of upper and lower limb fractures.

• Subjects who did not complete study endpoints, however, were included as part on an intention to treat analysis.

Exclusion Criteria:

• Age <6 months

• Body temperature of > 38 ̊C, due to upper respiratory tract infection.

• Participants having any other complications such as cardiovascular, gastrointestinal, psychological and neurological .

• Patients who have withdrawn from the study, or those receiving benzodiazepines and other sedative drugs within 6 hours prior to enrollment.

• Subjects who refused to give consent or those who were judged by investigator as non eligible were excluded as well.