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A comparison of sedation with midazolam – ketamine versus propofol – fentanyl during endoscopy in children: a randomized trial

View Article: PubMed Central - PubMed

ABSTRACT

Purpose: We aimed to compare the efficacy and safety of midazolam plus ketamine versus fentanyl plus propofol combination administered to children undergoing upper gastrointestinal endoscopy (UGE) and to determine the most appropriate sedation protocol.

Materials and methods: This prospective, randomized, single-blind study included patients between the ages of 4 and 17 years who underwent UGE for diagnostic purposes. Patients were divided randomly into groups A (midazolam–ketamine combination, n=119) and B (fentanyl plus propofol combination, n=119). The effectiveness of the sedation and complications during the procedure and recovery period were recorded.

Results: The processes started without an additional dose of the drug for 118 patients (99.1%) in group A and for 101 patients (84.8%) in group B (P=0.001). The average dose of ketamine administered to the patients in group A was 1.03±0.15 mg/kg and the average dose of propofol administered to the patients in group B was 1.46±0.55 mg/kg. None of the patients stopped the endoscopic procedure in group A, but one patient (0.8%) had to discontinue the endoscopic procedure in group B. 27 patients in group A (22.7%) and 41 patients (34.5%) in group B developed complications during the procedure (P=0.044). The rate of complications during the recovery of group A (110 patients, 92.4%) was significantly higher than that in group B (48 patients, 40.3%) (P=0.001).

Conclusion: In children, UGE procedures can be quite comfortable when using the midazolam–ketamine combination. However, adverse effects related to ketamine were observed during recovery.

No MeSH data available.


Ramsay sedation score (RSS) of the patients.
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Figure 1: Ramsay sedation score (RSS) of the patients.

Mentions: The average endoscopic procedure duration was about 5 min (range: 3–8 min, mean±SD: 4.55±0.75 min). No difference was recorded in the endoscopic procedure times between the two groups (Table 2). RSS measured during the intervention (after the endoscope passed the oesophagus and until the end of the procedure) was significantly higher in group A than in group B (mean±SD: 4.94±1.17 vs. 2.98±1.88, P<0.01). There were 41 patients with an RSS score of 6 in group A (34.5%) and five patients in group B with an RSS score of 6 (4.2%). There were only six patients with an RSS score of one in group A (5.0%), but 52 patients with an RSS score of one in group B (43.7%) (Fig. 1). A post-hoc power analysis showed that from the data obtained from our study, power was calculated to be 99%, indicating a significant difference in RSS between the groups.


A comparison of sedation with midazolam – ketamine versus propofol – fentanyl during endoscopy in children: a randomized trial
Ramsay sedation score (RSS) of the patients.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5134819&req=5

Figure 1: Ramsay sedation score (RSS) of the patients.
Mentions: The average endoscopic procedure duration was about 5 min (range: 3–8 min, mean±SD: 4.55±0.75 min). No difference was recorded in the endoscopic procedure times between the two groups (Table 2). RSS measured during the intervention (after the endoscope passed the oesophagus and until the end of the procedure) was significantly higher in group A than in group B (mean±SD: 4.94±1.17 vs. 2.98±1.88, P<0.01). There were 41 patients with an RSS score of 6 in group A (34.5%) and five patients in group B with an RSS score of 6 (4.2%). There were only six patients with an RSS score of one in group A (5.0%), but 52 patients with an RSS score of one in group B (43.7%) (Fig. 1). A post-hoc power analysis showed that from the data obtained from our study, power was calculated to be 99%, indicating a significant difference in RSS between the groups.

View Article: PubMed Central - PubMed

ABSTRACT

Purpose: We aimed to compare the efficacy and safety of midazolam plus ketamine versus fentanyl plus propofol combination administered to children undergoing upper gastrointestinal endoscopy (UGE) and to determine the most appropriate sedation protocol.

Materials and methods: This prospective, randomized, single-blind study included patients between the ages of 4 and 17 years who underwent UGE for diagnostic purposes. Patients were divided randomly into groups A (midazolam&ndash;ketamine combination, n=119) and B (fentanyl plus propofol combination, n=119). The effectiveness of the sedation and complications during the procedure and recovery period were recorded.

Results: The processes started without an additional dose of the drug for 118 patients (99.1%) in group A and for 101 patients (84.8%) in group B (P=0.001). The average dose of ketamine administered to the patients in group A was 1.03&plusmn;0.15&thinsp;mg/kg and the average dose of propofol administered to the patients in group B was 1.46&plusmn;0.55&thinsp;mg/kg. None of the patients stopped the endoscopic procedure in group A, but one patient (0.8%) had to discontinue the endoscopic procedure in group B. 27 patients in group A (22.7%) and 41 patients (34.5%) in group B developed complications during the procedure (P=0.044). The rate of complications during the recovery of group A (110 patients, 92.4%) was significantly higher than that in group B (48 patients, 40.3%) (P=0.001).

Conclusion: In children, UGE procedures can be quite comfortable when using the midazolam&ndash;ketamine combination. However, adverse effects related to ketamine were observed during recovery.

No MeSH data available.