A Randomized Study to Compare the Efficacy Between Intranasal and Intravenous Dexmedetomidine for the Removal of Foreign Bodies in the Esophagus at the Cricopharynx Level in Pediatric Patients

Abstract

Background: Foreign body (coins, magnets, button batteries, and metallic foreign bodies) ingestion is common and causes significant morbidity and mortality in children aged six months to three years. Endoscopic removal of swallowed foreign substances is widely accepted, but sedation and general anesthesia may be required to alleviate pain and anxiety during the procedure. Dexmedetomidine is used as a sedative, hypnotic, anxiolytic, and analgesic. In this study, we aimed to investigate and compare the efficacy between the intranasal (IN) and intravenous (IV) routes for the administration of dexmedetomidine as an adjunct to propofol for the removal of foreign bodies in the esophagus at the cricopharynx level in pediatric patients.

Materials and method: This prospective, double-blinded, randomized study was conducted on 80 patients of either sex and American Society of Anaesthesiologists physical status (ASA PS) I and II aged one month to 12 years with a foreign body in the esophagus at the cricopharynx level undergoing endoscopic foreign body removal. Patients were randomly allocated into groups A and B, with 40 patients each. In the preoperative area group A, IN, 3 mcg/kg, was dripped equally in both nostrils (supine position). In Group B, IV, 3 mcg/kg, diluted in normal saline, was administered intravenously slowly over 10 minutes. The onset of sedation was assessed using the Ramsay Sedation Scale (RSS) every 10 minutes following dexmedetomidine administration, and when an RSS score of 3 or above was achieved, the patient was transferred to the operation theater. In the operation room, patients were induced with injection propofol in a dose of 2 mg/kg or until the loss of verbal response. Parent separation scale scoring was used to evaluate the child's behavior on separation from parents as a tool to assess the anxiolytic property of dexmedetomidine. Perioperative pain using the Wong-Baker Faces pain rating scale, heart rate (HR), oxygen saturation (SpO₂), ECG, and blood pressure (BP) were monitored before drug delivery till the end of the procedure. Statistical analysis was done using SPSS version 24.0 (IBM Corp., Armonk, NY).

Results: The mean time (minutes) in shifting to operation theater (33.8 ± 5) was significantly higher in group A compared to group B (10.7 ± 2.1) (p = 0.001). The mean Ramsay Sedation Score was higher at 10 and 20 minutes in group B as compared to group A. Group B had significantly lower pain (2.2 ± 1.4) (p ≤ 0.001) at 10 minutes, while in group A, the pain score decreased slowly and took more time but remains lower (1.35 ± 0.94) for longer duration (120 minutes) in the postoperative period in comparison to Group B (1.94 ± 0.35) (p = 0.002). Group B had a sharp hemodynamic decrease, while group A had slow, persistent changes.

Conclusion: IN administration of dexmedetomidine is a safer and more effective mode of sedation to remove a foreign body from the esophagus at the cricopharyngeal level in pediatric patients. It provides stable and sustained hemodynamic parameters and longer postoperative pain relief compared to IV dexmedetomidine.

Keywords: anesthesia; dexmedetomidine; foreign body ingestion; intranasal dexmedetomidine; intravenous dexmedetomidine; pediatric foreign body ingestion; pharyngeal foreign body.

Figure 1. Consolidated Standards of Reporting Trials (CONSORT) flow diagram.

Figure 2. Comparison of the mean heart rate in the preoperative duration between the study groups

HR: heart rate Data are expressed as mean ± SD and analyzed by unpaired t-test.

Figure 3. Comparison of the mean heart rate in the intraoperative duration between the study groups.

HR: heart rate, Intra op: intraoperative Data are expressed as mean ± SD and analyzed by unpaired t-test.

Figure 4. Comparison of the mean arterial pressure (pre-op) among the groups

MAP: mean arterial pressure, Pre op: preoperative Data are expressed as mean ± SD and analyzed by unpaired t-test.

Figure 5. Comparison of the mean arterial pressure (intra-op) among the groups.

MAP: mean arterial pressure Data are expressed as mean ± SD and analyzed by unpaired t-test.

Figure 6. Comparison of the peripheral saturation of oxygen SpO2 (%) among the groups

Data are expressed as mean ± SD and analyzed by unpaired t-test.

Figure 7. Comparison of the mean Ramsay sedation score between the study groups

Data are expressed as mean ± SD and analyzed by unpaired t-test.

Figure 8. Comparison of the mean Wong-Baker Faces Pain Score in the pre-op between the study groups

Pre op: preoperative Data are expressed as mean ± SD and analyzed by unpaired t-test.

Figure 9. Comparison of the mean Wong-Baker Faces Pain Score during the procedure between the study groups

Intra op: intraoperative Data are expressed as mean ± SD and analyzed by unpaired t-test.

Figure 10. Comparison of the mean Wong-Baker Faces Pain Score after the procedure between the study groups

Post op: postoperative Data are expressed as mean ± SD and analyzed by unpaired t-test.