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Pain management following myringotomy and tube placement: intranasal dexmedetomidine versus intranasal fentanyl.

ABSTRACT: Despite the brevity of the procedure, bilateral myringotomy and tympanostomy tube placement (BMT) can result in significant postoperative pain and discomfort. As the procedure is frequently performed without intravenous access, non-parenteral routes of administration are frequently used for analgesia. The current study prospectively compares the efficacy of intranasal (IN) dexmedetomidine with IN fentanyl for children undergoing BMT.This prospective, double-blinded, randomized clinical trial included pediatric patients undergoing BMT. The patients were randomized to receive either IN dexmedetomidine (1 ?g/kg) or fentanyl (2 ?g/kg) after the induction of general anesthesia with sevoflurane. All patients received rectal acetaminophen (40 mg/kg) and the first 50 patients also received premedication with oral midazolam. Postoperative pain and recovery were assessed using pediatric pain and recovery scales, and any adverse effects were monitored for.The study cohort included 100 patients who ranged in age from 1 to 7.7 years and in weight from 8.6 to 37.4 kg. They were divided into 4 groups with 25 patients in each group: (1) midazolam premedication+IN dexmedetomidine; (2) midazolam premedication+IN fentanyl; (3) no premedication+IN dexmedetomidine; and (4) no premedication+IN fentanyl. Pain scores were comparable when comparing groups 2, 3 and 4, but were higher in group 1 (midazolam premedication with IN dexmedetomidine). There was no difference in total time in the post-anesthesia care unit (PACU) or time from arrival in the PACU until hospital discharge between the 4 groups. The heart rate (HR) was significantly lower in group 3 when compared to the other groups at several different times after arrival to the PACU. No clinically significant difference was noted in blood pressure.Following BMT, when no premedication is administered, there was no clinical advantage when comparing IN dexmedetomidine (1 ?g/kg) to IN fentanyl (2 ?g/kg). The addition of oral midazolam as a premedication worsened the outcome measures particularly for children receiving IN dexmedetomidine.

SUBMITTER: Dewhirst E

PROVIDER: S-EPMC4160729 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Pain management following myringotomy and tube placement: intranasal dexmedetomidine versus intranasal fentanyl.

Dewhirst Elisabeth E Fedel Gina G Raman Vidya V Rice Julie J Barry N'Diris N Jatana Kris R KR Elmaraghy Charles C Merz Meredith M Tobias Joseph D JD

International journal of pediatric otorhinolaryngology 20140416 7

<h4>Purpose</h4>Despite the brevity of the procedure, bilateral myringotomy and tympanostomy tube placement (BMT) can result in significant postoperative pain and discomfort. As the procedure is frequently performed without intravenous access, non-parenteral routes of administration are frequently used for analgesia. The current study prospectively compares the efficacy of intranasal (IN) dexmedetomidine with IN fentanyl for children undergoing BMT.<h4>Methods</h4>This prospective, double-blinde ...[more]

PMID: 24814231

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Project description:Dexmedetomidine as a sole agent showed limited use for painful procedures due to its insufficient sedative/analgesic effect, pronounced hemodynamic instability and prolonged recovery. The aim of this study was to compare the effects of dexmedetomidine-ketamine (DK) versus dexmedetomidine-midazolam-fentanyl (DMF) combination on the quality of sedation/analgesia and recovery profiles for monitored anesthesia care (MAC).Fifty six patients undergoing chemoport insertion were randomly assigned to group DK or DMF. All patients received 1 μg.kg(-1) dexmedetomidine over 10 min followed by 0.2-1.0 μg.kg(-1)h(-1) in order to maintain 3 or 4 of modified Observer's Assessment of Analgesia and Sedation score checked every 3 min. At the start of dexmedetomidine infusion, patients in group DK or DMF received 0.5 mg.kg(-1) ketamine or 0.05 mg.kg(-1) midazolam + 0.5 μg.kg(-1) fentanyl intravenously, respectively. When required, rescue sedatives (0.5 mg.kg-1 of ketamine or 0.05 mg.kg-1 of midazolam) and analgesics (0.5 mg.kg-1 of ketamine or 0.5 μg.kg-1 of fentanyl) were given to the patients in DK or DMF group, respectively. The primary outcome of this study was the recovery parameters (time to spontaneous eye opening and the length of the recovery room stay). The secondary outcomes were parameters indicating quality of sedation/analgesia, cardiorespiratory variables, and satisfaction scores.There were no significant differences in the onset time, time to spontaneous eye opening, recovery room stay, the incidences of inadequate analgesia, hypotension and bradycardia between the two groups. Despite lower infusion rate of dexmedetomidine, more patients in the DMF group had bispectral index (BIS) < 60 than in the DK group and vice versa for need of rescue sedatives. The satisfaction scores of patients, surgeon, and anesthesiologist in the DMF group were significantly better than the DK group.The DK and DMF groups showed comparable recovery time, onset time, cardiorespiratory variables, and analgesia. However, the DMF group showed a better sedation quality and satisfaction scores despite the lower infusion rate of dexmedetomidine, and a higher incidence of BIS < 60 than the DK group.Clinical Trial Registry of Korea KCT0000951 , registered 12/12/2013.

Project description:OBJECTIVE:Intranasal fentanyl (INF) quickly and noninvasively relieves severe pain, whereas intravenous hydromorphone (IVH) reliably treats severe cancer pain but requires vascular access. The trial evaluated the efficacy of INF relative to IVH for treating cancer patients with severe pain in an emergency department (ED) setting. METHODS:We randomized 82 patients from a comprehensive cancer center ED to receive INF (n = 42) or IVH (n = 40). Eligible patients reported severe pain at randomization (?7, scale: 0 "none" to 10 "worst pain"). We conducted non-inferiority comparisons (non-inferiority margin = 0.9) of pain change from treatment initiation (T0) to one hour later (T60). T0 pain ratings were unavailable; therefore, we estimated T0 pain by comparing 1) T60 ratings, assuming similar group T0 ratings; 2) pain change, estimating T0 pain = randomization ratings, and 3) pain change, with T0 pain = 10 (IVH group) or T0 pain = randomization rating (INF group). RESULTS:At T60, the upper 90% confidence limit (CL) of the mean log-transformed pain ratings for the INF group exceeded the mean IVH group rating by 0.16 points (>pain). Substituting randomization ratings for T0 pain, the lower 90% CL of mean pain change in the INF group extended 0.32 points below (<pain relief) mean change in the IVH group. Finally, assuming all subjects in the IVH group had maximum pain at T0 and that T0 pain for the INF group remained unchanged from randomization, the lower bound of the 90% CL for mean pain decrease in the INF group extended 1.37 points below (<pain relief) mean decrease in the IVH group. Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001). CONCLUSIONS:Two of three analyses supported non-inferiority of INF versus IVH, while one analysis was inconclusive. Compared to IVH, INF had the advantage of shorter time to administration. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02459964.

Project description:ObjectiveThe aim of this study was to report preliminary data on the use of intranasal dexmedetomidine to treat postoperative restlessness, agitation, and pain in 23 patients aged > 70 years and undergoing orthopedic surgery.BackgroundPostoperative agitation and delirium are common among older adult patients undergoing orthopedic surgery. Most preparations used to treat agitation and delirium carry a risk for adverse events such as respiratory failure. Moreover, mere opioid therapy may be insufficient in treatment of pain. Dexmedetomidine, an α2-adrenoreceptor agonist with sedative and analgesic properties, has been shown to reduce opioid requirement and reduce postoperative delirium in older adults.MethodsWe studied the use of post-operative intranasal dexmedetomidine in a retrospective study cohort of geriatric patients undergoing orthopedic surgery. Primary outcomes included alterations in heart rate (HR), mean arterial pressure (MAP), respiratory rate (RR), peripheral oxygen saturation (SpO2), Modified Richmond Agitation and Sedation Score (mRASS), and opioid consumption following dexmedetomidine administration.ResultsWe identified 23 patients with a mean (SD) age of 79.9 (7.5) years who received dexmedetomidine 100 µg intranasally postoperatively. After dexmedetomidine administration, HR decreased by 10.4 (3.7) beats/min (95% CI 2.9-17.8; p = 0.004) and MAP by 16.2 (4.4) mmHg (95% CI 7.3-25.1; p < 0.001). HR decrease was significant at 2 h and MAP decrease at 1, 2, and 3 h following dexmedetomidine administration. Dexmedetomidine administration was associated with significant reductions in opioid consumption (p < 0.001) and mRASS score (p < 0.001). SpO2 and RR remained unchanged.ConclusionsThese preliminary findings suggest that intranasal dexmedetomidine reduces opioid consumption without causing respiratory depression and may be used to treat postoperative restlessness, agitation, and pain in geriatric patients. However, hemodynamic effects of dexmedetomidine may require close observation for 3 hours following administration in older adult patients.

Project description:Importance:Timely analgesia is critical for children with injuries presenting to the emergency department, yet pain control efforts are often inadequate. Intranasal administration of pain medications provides rapid analgesia with minimal discomfort. Opioids are historically used for significant pain from traumatic injuries but have concerning adverse effects. Intranasal ketamine may provide an effective alternative. Objective:To determine whether intranasal ketamine is noninferior to intranasal fentanyl for pain reduction in children presenting with acute extremity injuries. Design, Setting, and Participants:The Pain Reduction With Intranasal Medications for Extremity Injuries (PRIME) trial was a double-blind, randomized, active-control, noninferiority trial in a pediatric, tertiary, level 1 trauma center. Participants were children aged 8 to 17 years presenting to the emergency department with moderate to severe pain due to traumatic limb injuries between March 2016 and February 2017. Analyses were intention to treat and began in May 2017. Interventions:Intranasal ketamine (1.5 mg/kg) or intranasal fentanyl (2 µg/kg). Main Outcomes and Measures:The primary outcome was reduction in visual analog scale pain score 30 minutes after intervention. The noninferiority margin for this outcome was 10. Results:Of 90 children enrolled, 45 (50%) were allocated to ketamine (mean [SD] age, 11.8 [2.6] years; 26 boys [59%]) and 45 (50%) to fentanyl (mean [SD] age, 12.2 [2.3] years; 31 boys [74%]). Thirty minutes after medication, the mean visual analog scale reduction was 30.6 mm (95% CI, 25.4-35.8) for ketamine and 31.9 mm (95% CI, 26.6-37.2) for fentanyl. Ketamine was noninferior to fentanyl for pain reduction based on a 1-sided test of group difference less than the noninferiority margin, as the CIs crossed 0 but did not cross the prespecified noninferiority margin (difference in mean pain reduction between groups, 1.3; 90% CI, -6.2 to 8.7). The risk of adverse events was higher in the ketamine group (relative risk, 2.5; 95% CI, 1.5-4.0), but all events were minor and transient. Rescue analgesia was similar between groups (relative risk, 0.89; 95% CI, 0.5-1.6). Conclusions and Relevance:Ketamine provides effective analgesia that is noninferior to fentanyl, although participants who received ketamine had an increase in adverse events that were minor and transient. Intranasal ketamine may be an appropriate alternative to intranasal fentanyl for pain associated with acute extremity injuries. Ketamine should be considered for pediatric pain management in the emergency setting, especially when opioids are associated with increased risk. Trial Registration:ClinicalTrials.gov Identifier: NCT02778880.

Dataset Information

Pain management following myringotomy and tube placement: intranasal dexmedetomidine versus intranasal fentanyl.

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Pain management following myringotomy and tube placement: intranasal dexmedetomidine versus intranasal fentanyl.

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