Comparison of preadministered and coadministered lidocaine for treating pain and distress associated with intranasal midazolam administration in children: A randomized clinical trial

O’Connell, Nicole C.; Woodward, Hilary A.; Flores-Sanchez, Pamela L.; McLaren, Son H.; Ieni, Maria; McKinley, Kenneth W.; Shen, Sripriya T.; Dayan, Peter; Tsze, Daniel S

doi:10.1002/emp2.12227

Cited by 8 publications

(4 citation statements)

References 16 publications

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“…In this study, it appears there was no benefit to adding lidocaine and in fact, it appears to worsen complaints at the time of administration. Our findings are consistent with O'Connell et al who reported that pain and distress were comparable when intranasal lidocaine was administered before or concurrently with INM, but that intranasal lidocaine alone also caused significant pain and distress [17]. A combined dose would allow a single atomized dose compared to potential distress caused by two separate doses of Xylocaine (lidocaine) and midazolam.…”

Section: Discussionsupporting

confidence: 91%

Intranasal Midazolam With Lidocaine for Sedation in Pediatric Myringotomy and Tube Surgery: A Randomized Controlled Trial

Ullman¹,

Victory²,

Scribani³

2022

Cureus

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Background and Aims: Intranasal midazolam (INM) sedation for children has been associated with side effects. This prospective, double-blind, placebo-controlled trial assessed whether the addition of lidocaine to INM (INM+L) affected efficacy or discharge time among pediatric patients undergoing elective bilateral myringotomy and tube placement (BMT). Methods: This trial enrolled children aged between 18 months to seven years undergoing BMT, physical status class 1 or 2, in a single academic medical center. Interventions were placebo (intranasal saline), INM only (0.2mg/kg of INM concentration 5mg/ml), and INM+L (0.2mg/kg INM with addition of lidocaine 4% based on 25% of midazolam volume). Outcomes included post-anesthesia care unit times, observed behavioral distress (OBD) visual analog scale (VAS) (by nurse and parent), and sedation scores by certified registered nurse anesthetist (CRNA) and registered nurse (RN).Results: Forty-two subjects were included, 14 in each group, with 52% female, 41% physical status 2, and an average age of 2.7 years. Post-anesthesia care unit times averaged 36.5 minutes (range 15-132 minutes), with no delay in discharge with INM or INM+L versus placebo (p=0.88). Verbal complaints were highest among INM+L at the time of administration (p=0.01). RN-scored OBD at one minute post administration differed significantly across the three groups (p=0.01). Parental OBD scores did not differ across treatment groups. Agitation was greatest at time of induction of anesthesia in the placebo group (p=0.01).Conclusions: The addition of licodaine to INM does not adversely influence time to discharge and does not reduce side effects, improve efficacy, or change duration of action of INM.

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Section: Discussionsupporting

confidence: 91%

Intranasal Midazolam With Lidocaine for Sedation in Pediatric Myringotomy and Tube Surgery: A Randomized Controlled Trial

Ullman¹,

Victory²,

Scribani³

2022

Cureus

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“…Rather, it has prompted the study of different strategies for treating this pain so that children can still benefit from its favorable properties (e.g. rapid onset, needle‐free administration, effective anxiolysis), such as with the pre‐treatment or co‐administration with lidocaine 57,60‐63 14,48,49,51 .…”

Section: Discussionmentioning

confidence: 99%

“…rapid onset, needle-free administration, effective anxiolysis), such as with the pre-treatment or co-administration with lidocaine. 57,[60][61][62][63] The administration of the IN formulation of ketorolac containing lidocaine has been associated with nasal pain in 5-20% of patients, with the degree of pain intensity rated as "mild" in one study. 14,48,49,51 However, further research is necessary to better describe the effect of lidocaine or…”

Section: Ta B L E 1 (Continued)mentioning

confidence: 99%

Intranasal ketorolac versus intravenous ketorolac for treatment of migraine headaches in children: A randomized clinical trial

Tsze

Lubell

Carter

et al. 2021

Academic Emergency Medicine

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Background Intravenous ketorolac is commonly used for treating migraine headaches in children. However, the prerequisite placement of an intravenous line can be technically challenging, time‐consuming, and associated with pain and distress. Intranasal ketorolac may be an effective alternative that is needle‐free and easier to administer. We aimed to determine whether intranasal ketorolac is non‐inferior to intravenous ketorolac for reducing pain in children with migraine headaches. Methods We conducted a randomized double‐blind non‐inferiority clinical trial. Children aged 8–17 years with migraine headaches, moderate to severe pain, and requiring parenteral analgesics received intranasal ketorolac (1 mg/kg) or intravenous ketorolac (0.5 mg/kg). Primary outcome was reduction in pain at 60 min after administration measured using the Faces Pain Scale‐Revised (scored 0–10). Non‐inferiority margin was 2/10. Secondary outcomes included time to onset of clinically meaningful decrease in pain; ancillary emergency department outcomes (e.g. receipt of rescue medications, headache relief, headache freedom, percentage improvement); 24‐h follow‐up outcomes; functional disability; and adverse events. Results Fifty‐nine children were enrolled. We analyzed 27 children who received intranasal ketorolac and 29 who received intravenous ketorolac. The difference in mean pain reduction at 60 min between groups was 0.2 (95% CI −0.9, 1.3), with the upper limit of the 95% CI being less than the non‐inferiority margin. There were no statistical differences between groups for secondary outcomes. Conclusions Intranasal ketorolac was non‐inferior to intravenous ketorolac for reducing migraine headache pain in the emergency department.

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“…Although the intranasal route for midazolam is well studied, a significant proportion of preterm babies at TEA require nasal cannula or CPAP. Utilizing the intranasal route might pose problems with instilling and briefly disconnecting the nasal interface and causing discomfort and burning sensation intranasally [18][19][20]. Hence, we proposed a novel approach of using buccal midazolam as the agent of choice for providing procedural sedation for MRI in patients who were not on mechanical ventilation.…”

Section: Introductionmentioning

confidence: 99%

Intervention Bundle for Optimization of Procedural Sedation for Newborns Undergoing Magnetic Resonance Imaging: A Single-Center Quality Improvement Project in Qatar

Daoud,

Karayil Mohammad Ali,

Chakkarapani

et al. 2024

Biomed Hub

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Introduction: Magnetic resonance imaging (MRI) is a common procedure in tertiary care neonatal intensive care units (NICUs). MRIs aid in detailing structural anatomy and are increasingly utilized for prognostication. Keeping babies calm and motion-free in the MRI suite is challenging, and various approaches have been adopted to obtain the best image quality. We share our experience of intervention bundle for procedural sedation with the novel use of buccal midazolam in our NICU for babies undergoing MRI. Methods: This single-center quality improvement project comprised two epochs. Epoch 1 from April 2018 to December 2020 provided baseline data regarding sedation use and helped identify causes for suboptimal images and the adverse event rate. Following the implementation of an interventional bundle comprising specific midazolam dose recommendations tailored to background risk factors and streamlining the procedural sedation process, similar comparative data were collected in epoch 2 (May 2021 to December 2022) after a washout period. Results: Of 424 patients, 238 and 108 had MRI done under either procedural sedation protocol or feed and wrap technique in epoch 1 and 2, respectively. After excluding babies whose MRIs were performed under sedative infusions, 30 (13%) babies had adverse events in epoch 1, while only 8 (7%) events occurred in epoch 2. There was also a 37% improvement in the documentation of procedural sedation between the two epochs. Conclusion: Procedural sedation with buccal midazolam under neonatologist supervision is safe, efficient, and effective in babies undergoing MRI in this single-center study. More extensive studies may be warranted to assess the suitability of this sedation modality for broader use.

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Comparison of preadministered and coadministered lidocaine for treating pain and distress associated with intranasal midazolam administration in children: A randomized clinical trial

Cited by 8 publications

References 16 publications

Intranasal Midazolam With Lidocaine for Sedation in Pediatric Myringotomy and Tube Surgery: A Randomized Controlled Trial

Intranasal Midazolam With Lidocaine for Sedation in Pediatric Myringotomy and Tube Surgery: A Randomized Controlled Trial

Intranasal ketorolac versus intravenous ketorolac for treatment of migraine headaches in children: A randomized clinical trial

Intervention Bundle for Optimization of Procedural Sedation for Newborns Undergoing Magnetic Resonance Imaging: A Single-Center Quality Improvement Project in Qatar

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