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Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial.

ABSTRACT: Importance:Ibuprofen is an effective analgesic after tonsillectomy alone or tonsillectomy with adenoidectomy, but concerns remain about whether it increases postoperative hemorrhage. Objective:To investigate the effect of ibuprofen compared with acetaminophen on posttonsillectomy bleeding (PTB) requiring surgical intervention in children. Design, Setting, and Participants:A multicenter, randomized, double-blind noninferiority trial was conducted at 4 tertiary medical centers (Massachusetts Eye and Ear Infirmary, Boston; Naval Medical Center, San Diego, California; Naval Medical Center, Portsmouth, Virginia; Madigan Army Medical Center, Tacoma, Washington). A total of 1832 children were assessed for eligibility (presence of sleep-disordered breathing or obstructive sleep apnea, adenotonsillar hypertrophy, or infectious tonsillitis undergoing extracapsular tonsillectomy by electrocautery). Of these, 1091 were excluded because they did not meet eligibility criteria (n?=?681) or refused to participate (n?=?410); thus, 741 children aged 2 to 18 years undergoing tonsillectomy alone or tonsillectomy with adenoidectomy were enrolled between May 3, 2012, and January 20, 2017. Interventions:Participants were randomized to receive ibuprofen, 10 mg/kg (n?=?372), or acetaminophen, 15 mg/kg (n?=?369), every 6 hours for the first 9 postoperative days. Main Outcomes and Measures:Rate and severity of posttonsillectomy bleeding were recorded using a postoperative bleeding severity scale: type 1 (bleeds that were observed at home or evaluated in the emergency department without further intervention), type 2 (bleeds that required readmission for observation), and type 3 (bleeds that required a return to the operating room for control of hemorrhage). Type 3 bleeding was the main outcome measure. The noninferiority margin was set at 3%, and modified intention-to-treat analysis was used. Results:Of the 741 children enrolled, 688 children (92.8%) (median [interquartile range] age, 5 [4] years; 366 boys [53.2%]) received the study medication and were included in a modified intention-to-treat analysis. The rate of bleeding requiring operative intervention was 1.2% in the acetaminophen group and 2.9% in the ibuprofen group (difference, 1.7%; 97.5% CI upper limit, 3.8%; P?=?.12 for noninferiority). There were no significant adverse events or deaths. Conclusions and Relevance:This study could not exclude a higher rate of severe bleeding in children receiving ibuprofen after tonsillectomy alone or tonsillectomy with adenoidectomy. This finding should be considered when selecting a postoperative analgesic regimen. Further studies are needed to understand if bleeding risk is affected when ibuprofen is used for a shorter duration or in combination with acetaminophen for postoperative analgesia. Trial Registration:ClinicalTrials.gov identifier: NCT01605903.

SUBMITTER: Diercks GR

PROVIDER: S-EPMC6583024 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial.

Diercks Gillian R GR Comins Jill J Bennett Kara K Gallagher Thomas Q TQ Brigger Matthew M Boseley Mark M Gaudreau Philip P Rogers Derek D Setlur Jennifer J Keamy Donald D Cohen Michael S MS Hartnick Christopher C

JAMA otolaryngology-- head & neck surgery 20190601 6

<h4>Importance</h4>Ibuprofen is an effective analgesic after tonsillectomy alone or tonsillectomy with adenoidectomy, but concerns remain about whether it increases postoperative hemorrhage.<h4>Objective</h4>To investigate the effect of ibuprofen compared with acetaminophen on posttonsillectomy bleeding (PTB) requiring surgical intervention in children.<h4>Design, setting, and participants</h4>A multicenter, randomized, double-blind noninferiority trial was conducted at 4 tertiary medical center ...[more]

PMID: 30946442

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Project description:BackgroundNonsteroidal antiinflammatory drug use has been shown to increase blood pressure in nonpregnant adults. Because of this, the American College of Obstetricians and Gynecologists suggests avoiding their use in women with postpartum hypertension; however, evidence to support this recommendation is lacking.ObjectiveOur goal was to test the hypothesis that nonsteroidal antiinflammatory drugs, such as ibuprofen, adversely affect postpartum blood pressure control in women with preeclampsia with severe features.Study designAt delivery, we randomized women with preeclampsia with severe features to receive around-the-clock oral dosing with either 600 mg of ibuprofen or 650 mg of acetaminophen every 6 hours. Dosing began within 6 hours after delivery and continued until discharge, with opioid analgesics available as needed for breakthrough pain. Study drugs were encapsulated in identical capsules such that patients, nurses, and physicians were masked to study allocation. Exclusion criteria were serum aspartate aminotransferase or alanine aminotransferase >200 mg/dL, serum creatinine >1.0 mg/dL, infectious hepatitis, gastroesophageal reflux disease, age <18 years, or current incarceration. Our primary outcome was the duration of severe-range hypertension, defined as the time (in hours) from delivery to the last blood pressure ≥160/110 mm Hg. Secondary outcomes were time from delivery to last blood pressure ≥150/100 mm Hg, mean arterial pressure, need for antihypertensive medication at discharge, prolongation of hospital stay for blood pressure control, postpartum use of short-acting antihypertensives for acute blood pressure control, and opioid use for breakthrough pain. We analyzed all outcome data according to intention-to-treat principles.ResultsWe assessed 154 women for eligibility, of whom 100 met entry criteria, agreed to participate, and were randomized to receive postpartum ibuprofen or acetaminophen for first-line pain control. Seven patients crossed over or did not receive their allocated study drug, and 93 completed the study protocol in their assigned groups. We found no differences in baseline characteristics between groups, including mode of delivery, body mass index, parity, race, chronic hypertension, and maximum blood pressure prior to delivery. We did not find a difference in the duration of severe-range hypertension in the ibuprofen vs acetaminophen groups (35.3 vs 38.0 hours, P = .30). There were no differences between groups in the secondary outcome measures of time from delivery to last blood pressure ≥150/100 mm Hg, postpartum mean arterial pressure, maximum postpartum systolic or diastolic blood pressures, any postpartum blood pressure ≥160/110 mm Hg, short-acting antihypertensive use for acute blood pressure control, length of postpartum stay, need to extend postpartum stay for blood pressure control, antihypertensive use at discharge, or opioid use for inadequate pain control. In a subgroup analysis of patients who experienced severe-range hypertension, the mean time to blood pressure control in the acetaminophen group was 68.4 hours and ibuprofen group was 56.7 hours (P = .26). At 6 weeks postpartum, there were no differences between groups in the rates of obstetric triage visits, hospital readmissions, continued opioid use, or continued antihypertensive use.ConclusionThe first-line use of ibuprofen rather than acetaminophen for postpartum pain did not lengthen the duration of severe-range hypertension in women with preeclampsia with severe features.

Project description:ImportanceThe American Academy of Otolaryngology-Head and Neck Surgery Foundation has recommended yearly surgeon self-monitoring of posttonsillectomy bleeding rates. However, the predicted distribution of rates to guide this monitoring remain unexplored.ObjectiveTo use a national cohort of children to estimate the probability of bleeding after pediatric tonsillectomy to guide surgeons in self-monitoring of this event.Design, settings, and participantsThis retrospective cohort study used data from the Pediatric Health Information System for all pediatric (<18 years old) patients who underwent tonsillectomy with or without adenoidectomy in a children's hospital in the US from January 1, 2016, through August 31, 2021, and were discharged home. Predicted probabilities of return visits for bleeding within 30 days were calculated to estimate quantiles for bleeding rates. A secondary analysis included logistic regression of bleeding risk by demographic characteristics and associated conditions. Data analyses were conducted from August 7, 2022 to January 28, 2023.Main outcomes and measuresRevisits to the emergency department or hospital (inpatient/observation) for bleeding (primary/secondary diagnosis) within 30 days after index discharge after tonsillectomy.ResultsOf the 96 415 children (mean [SD] age, 5.3 [3.9] years; 41 284 [42.8%] female; 46 954 [48.7%] non-Hispanic White individuals) who had undergone tonsillectomy, 2100 (2.18%) returned to the emergency department or hospital with postoperative bleeding. The predicted 5th, 50th, and 95th quantiles for bleeding were 1.17%, 1.97%, and 4.75%, respectively. Variables associated with bleeding after tonsillectomy were Hispanic ethnicity (OR, 1.19; 99% CI, 1.01-1.40), very high residential Opportunity Index (OR, 1.28; 99% CI, 1.05-1.56), gastrointestinal disease (OR, 1.33; 99% CI, 1.01-1.77), obstructive sleep apnea (OR, 0.85; 99% CI, 0.75-0.96), obesity (OR,1.24; 99% CI, 1.04-1.48), and being more than 12 years old (OR, 2.48; 99% CI, 2.12-2.91). The adjusted 99th percentile for bleeding after tonsillectomy was approximately 6.39%.Conclusions and relevanceThis retrospective national cohort study predicted 50th and 95th percentiles for posttonsillectomy bleeding of 1.97% and 4.75%. This probability model may be a useful tool for future quality initiatives and surgeons who are self-monitoring bleeding rates after pediatric tonsillectomy.

Project description:BackgroundThe management of pain resulting from anesthesia injection, tooth extraction and in the period after extraction is of great importance in pediatric dentistry.ObjectiveThe aim of this study was to compare the efficacy of the preemptive administration of ibuprofen or acetaminophen with placebo in reducing the pain during injection, extraction and postoperatively in children undergoing primary tooth extraction.Material and methodsA randomized, placebo-controlled, triple-blinded clinical trial of cooperative children who needed primary molar extraction by local anesthesia. Sixty-six children aged between 6 and 8 years were randomly assigned to one of three groups: (a) Acetaminophen syrup (320 mg/10 ml); (b) placebo solution; and (c) ibuprofen syrup (200 mg/10 ml). Each of the three solutions was given 30 min before administration of the local anesthetic agent. The Pain level was assessed using the Wong-Baker faces® pain rating scale after injection, extraction, and postoperatively. The Kruskal-Wallis and Mann-Whitney U test were used to evaluate the pain scores between groups at confidence level of 95%.ResultsThe use of preemptive analgesics showed lower pain scores compared to placebo. Additionally, only ibuprofen significantly reduced pain scores compared to placebo at the points immediately after injection (p = 0.001), immediately after extraction (p = 0.0001) and 5 h after extraction (p = 0.002).ConclusionPreemptive usage of ibuprofen reduces injection pain and relieves both extraction and postoperative pain in children undergoing primary tooth extraction. What this paper or case report adds It adds the knowledge regarding pain relief of injection and extraction in children. Preemptive analgesic medications have a beneficial effect on alleviating postoperative pain following tooth extraction in children. Ibuprofen is an effective analgesic for postoperative pain relief in children undergoing primary tooth extraction. Why this paper or case report is important to pediatric dentists Pediatric dentists may consider preemptive ibuprofen in children before injection and extractions. Identifies that Ibuprofen is an effective method of reducing postoperative pain.

Project description:ImportanceBlood type (BT) O has been identified as a risk factor for bleeding complications, while non-O BTs may increase risk for thromboembolic events. Limited data are available in children undergoing tonsillectomy with or without adenoidectomy.ObjectiveTo determine whether BT O is associated with hemorrhage after tonsillectomy with or without adenoidectomy.Design, setting, and participantsRetrospective cohort study of patients younger than 22 years who underwent tonsillectomy with or without adenoidectomy at a single institution between January 1, 2008, and August 7, 2017. Statistical analysis was performed from November 2017 to January 2019.Main outcomes and measuresPrevalence of hemorrhage following surgery was defined as any bleeding requiring cauterization up to 1 month after the procedure. Data on sex, age, von Willebrand disease (VWD) status, BT, white blood cell counts, and platelet counts closest to date of surgery were collected from an electronic medical record system, and the association of these factors with hemorrhage following surgery was investigated.ResultsA total of 14 951 pediatric patients (median [range] age, 5.6 [0.8-21.9] years; 6956 [46.5%] female) underwent tonsillectomy with or without adenoidectomy. Prevalence of hemorrhage following the procedure was 3.9% (578 patients) for the full cohort and 2.8% (362 of 13 065) for patients with no BT identified or preprocedure VWD panel results at baseline. Children who had a BT identified and/or a VWD panel before surgery had higher bleeding rates (BT only, 14.9% [172 of 1156]; preprocedure VWD panel only, 4.6% [28 of 607]; and BT and preprocedure VWD panel, 13.0% [16 of 123]), all of which were significantly different from the baseline bleeding rate (P < .001). While the bleeding rates in children with BT O were not statistically different from those with non-O BT (14.8% and 14.6%, respectively; P > .99), mean von Willebrand factor values were statistically different (mean [SD] von Willebrand factor antigen level in O group, 86.9 [42.4] IU/dL in the O group vs 118.0 [53.8] IU/dL in the non-O group; P = .002; and mean [SD] von Willebrand factor ristocetin-cofactor in the O group, 72.2 [44.3] IU/dL vs 112.6 [68.0] IU/dL in the non-O group; P = .001). In addition, children older than 12 years had increased bleeding rates in the full cohort (8.3% vs 3.2%), in the testing-naive cohort (6.5% vs 2.3%), and in those with a preprocedure VWD panel only (13.5% vs 3.1%) compared with children aged 12 years or younger.Conclusions and relevanceType O blood was not a risk factor associated with hemorrhage after tonsillectomy with or without adenoidectomy despite lower baseline von Willebrand factor antigen and von Willebrand factor ristocetin-cofactor values in children with BT O vs those with non-O BT in our study cohort. No association was found between VWD status and bleeding, and there was no difference in VWD panel values in those who experienced hemorrhage vs those who did not within BT groups. Further studies elucidating the utility of von Willebrand factor values for children undergoing tonsillectomy with or without adenoidectomy are needed.

Project description:IntroductionThis study aims to investigate the effectiveness of intravenous ibuprofen or intravenous ibuprofen plus acetaminophen compared to intravenous morphine in patients with closed extremity fractures.MethodsA triple-blinded randomized clinical trial was conducted at a tertiary trauma center in Iran. Adult patients between 15 and 60 years old with closed, isolated limb fractures and a pain intensity of at least 6/10 on the visual analog scale (VAS) were eligible. Patients with specific conditions or contraindications were not included. Participants were randomly assigned to receive intravenous ibuprofen, intravenous ibuprofen plus acetaminophen, or intravenous morphine. Pain scores were assessed using the visual analog scale at baseline and 5, 15, 30, and 60 min after drug administration. The primary outcome measure was the pain score reduction after one hour.ResultsOut of 388 trauma patients screened, 158 were included in the analysis. There were no significant differences in age or sex distribution among the three groups. The pain scores decreased significantly in all groups after 5 min, with the morphine group showing the lowest pain score at 15 min. The maximum effect of ibuprofen was observed after 30 min, while the ibuprofen-acetaminophen combination maintained its effect after 60 min. One hour after injection, pain score reduction in the ibuprofen-acetaminophen group was significantly more than in the other two groups, and pain score reduction in the ibuprofen group was significantly more than in the morphine group.ConclusionThe study findings suggest that ibuprofen and its combination with acetaminophen have similar or better analgesic effects compared to morphine in patients with closed extremity fractures. Although morphine initially provided the greatest pain relief, its effect diminished over time. In contrast, ibuprofen and the ibuprofen-acetaminophen combination maintained their analgesic effects for a longer duration. The combination therapy demonstrated the most sustained pain reduction. The study highlights the potential of non-opioid analgesics in fracture pain management and emphasizes the importance of initiation of these medications as first line analgesic for patients with fractures. These findings support the growing trend of exploring non-opioid analgesics in pain management.Trial registrationClinicalTrials.gov Identifier: NCT05630222 (Tue, Nov 29, 2022). The manuscript adheres to CONSORT guidelines.

Project description:BACKGROUND:Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS:In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS:Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P=0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P=0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P=0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P=0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P=0.94), or adverse events. CONCLUSIONS:Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.).

Project description:Importance:Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations. Objective:To investigate whether internet-delivered cognitive behavior therapy implemented within a stepped care model is noninferior to, and cost-effective compared with, the gold standard of face-to-face cognitive behavior therapy for pediatric obsessive-compulsive disorder. Design, Setting, and Participants:Multicenter, single-blind, randomized clinical noninferiority trial implemented at 2 specialist pediatric obsessive-compulsive disorder clinics in Stockholm and Gothenburg, Sweden. Participants are 152 children and adolescents aged 7 to 17 years with obsessive compulsive disorder, recruited through the 2 clinics and online self-referral. Patients will be randomized 1:1 to the stepped care intervention or face-to-face therapy. Blind evaluations will be conducted after treatment and at 3-month and 6-month follow-ups. At the 6-month follow-up (primary end point), noninferiority will be tested and resource use will be compared between the 2 treatment groups. Data will be analyzed according to intention-to-treat principles. Intervention:Patients randomized to stepped care will first receive internet-delivered cognitive behavior therapy for 16 weeks; patients who are classified as nonresponders 3 months after treatment completion will receive additional face-to-face therapy. The control group will receive 16 weeks of face-to-face cognitive behavior therapy immediately following randomization and nonresponders at the 3-month follow-up will, as in the stepped care group, receive additional face-to-face therapy. Main Outcomes and Measures:Noninferiority is defined as a 4-point difference on the primary outcome measure (Children's Yale-Brown Obsessive Compulsive Scale). Discussion:Recruitment started October 6, 2017, and was completed May 24, 2019. Results from the primary end point will be available by May 2020. The naturalistic follow-ups (1, 2, and 5 years after the end of treatment) will continue to 2025. There are no interim analyses planned or stopping rules for the trial. Trial Registration:ClinicalTrials.gov identifier: NCT03263546.

Project description:ObjectivesTo examine the volume, topics, and reporting trends in the published literature of randomized clinical trials for pharmacologic pain management of pediatric tonsillectomy and adenotonsillectomy and to identify areas requiring further research.Data sourcesPubMed (National Library of Medicine and National Institutes of Health), Scopus (Elsevier), CINAHL (EBSCO), and Cochrane Library (Wiley).MethodsA systematic search of four databases was conducted. Only randomized controlled or comparison trials examining pain improvement with a pharmacologic intervention in pediatric tonsillectomy or adenotonsillectomy were included. Data collected included demographics, pain-related outcomes, sedation scores, nausea/vomiting, postoperative bleeding, types of drug comparisons, modes of administration, timing of administration, and identities of the investigated drugs.ResultsOne hundred and eighty-nine studies were included for analysis. Most studies included validated pain scales, with the majority using visual-assisted scales (49.21%). Fewer studies examined pain beyond 24 h postoperation (24.87%), and few studies included a validated sedation scale (12.17%). Studies have compared several different dimensions of pharmacologic treatment, including different drugs, timing of administration, modes of administration, and dosages. Only 23 (12.17%) studies examined medications administered postoperatively, and only 29 (15.34%) studies examined oral medications. Acetaminophen only had four self-comparisons.ConclusionOur work provides the first scoping review of pain and pediatric tonsillectomy. With drug safety profiles considered, the literature does not have enough data to determine which treatment regimen provides superior pain control in pediatric tonsillectomy. Even common drugs like acetaminophen and ibuprofen require further research for optimizing the treatment of posttonsillectomy pain. The heterogeneity in study design and comparisons weakens the conclusions of potential systematic reviews and meta-analyses. Future directions include more noninferiority studies of unique comparisons and more studies examining oral medications given postoperatively.

Dataset Information

Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial.

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Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial.

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