A randomized, controlled multicenter feasibility pilot trial on imaging confirmed uncomplicated acute appendicitis: Appendectomy vs. symptomatic treatment in pediatric patients (the APPSYPP) trial study protocol.

INTRODUCTION: Imaging-confirmed uncomplicated acute appendicitis can be effectively and safely treated with antibiotics in most adults and children. Symptomatic treatment may have similar efficacy and safety. METHODS AND ANALYSIS: The APPSYPP trial is a randomized national multicenter feasibility superiority pilot study comparing appendectomy with symptomatic treatment in children with imaging-confirmed uncomplicated acute appendicitis. INCLUSION CRITERIA: 1) age ≥ 7 and < 16 years, 2) imaging-confirmed uncomplicated acute appendicitis and 3) CRP ≤ 65 mg/l. Patients are randomized to receive emergency laparoscopic appendectomy or symptomatic treatment. To ensure patient safety, symptomatically treated patients are hospitalized for at least 24 h receiving standard practice intravenous fluids and analgesics according to standard clinical practice. Primary outcome is 30-day treatment success defined by the absence of any treatment failure criteria. In appendectomy, treatment failure is defined as normal appendiceal histopathology or any postintervention complication requiring general anesthesia. In symptomatic treatment, treatment failure is defined as 1) inability for hospital discharge without appendectomy within 48 h after randomization with a finding of histopathologically inflamed appendix, 2) appendectomy during the initial hospital stay due to clinical progression of appendicitis with complicated acute appendicitis both histopathologically and surgically, 3) appendectomy with a histopathological finding of acute appendicitis after hospital discharge, or 4) any complication of appendicitis requiring general anesthesia. Detailed predefined secondary outcomes will be analyzed. ETHICS AND DISSEMINATION: Study was approved by Ethics Committee of Helsinki University Hospital (ID:HUS/1993/2021), conducted in compliance with the declaration of Helsinki with results disseminated in peer-reviewed scientific journals. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05289713).

An up-to-date overview of sublingual sufentanil for the treatment of moderate to severe pain.

INTRODUCTION: Sufentanil is a selective µ-opioid agonist, used intravenously and intrathecally for moderate to severe acute pain. Sublingual sufentanil nanotablets have been developed; 15 mcg tablet for a patient-controlled analgesia device and 30-mcg tablet for a single-dose device administered by a healthcare professional. Dosing interval is a minimum of 20 min for a 15 mcg tablet and a treatment duration of up to 72 hours. The single 30-mcg nanotablet dosing interval is 1 hour. Mean plasma elimination half-life is 13 hours and bioavailability 47-57% after the first sublingual sufentanil tablet. AREAS COVERED: This review focuses on the effectiveness, safety, and feasibility of sublingual sufentanil 30-mcg single dose suspended by a healthcare professional for the management of moderate to severe acute pain. A few Phase 4 studies concerning the sublingual sufentanil tablet system containing 15-mcg nanotablets are also reviewed. EXPERT OPINION: Sufentanil sublingual 30-mcg nanotablets provide effective pain relief in various acute moderate to severe pain states. The safety profile of sublingual sufentanil 30 mcg is typical to opioids nausea, vomiting, and sedation being the most common ones. Sublingual sufentanil 30-mcg nanotablet has the potential for efficient moderate to severe pain management in supervised healthcare facilities.

Sufentanil sublingual formulation for the treatment of acute, moderate to severe postoperative pain in adult patients.

INTRODUCTION: Sufentanil is a highly selective µ-opioid agonist commonly used by intravenous and intrathecal routes for acute pain. Sublingual sufentanil formulation for patient controlled analgesia (PCA) uses an innovative administration device that suspends a 15 µg nanotablet with a fixed lockout interval. The system is a non-invasive, less burdensome method of opioid delivery compared to intravenous and intrathecal routes. Sublingual nanotablet PCA transmucosal bioavailability is 59% and the meaningful analgesic onset time is 60 minutes. Areas covered: This paper focuses on the effectiveness, safety and feasibility of sufentanil PCA sublingual formulation for the management of postoperative pain. The paper is based on PubMed searches and the European Medicine Agency assessment report. Expert commentary: Under-treatment of acute pain is a substantial clinical problem. The initial experiences with the sublingual delivery system are encouraging. Sufentanil sublingual nanotablets intended for PCA device use are approved in Europe, and approval is pending in the United States.

Recovery after cataract surgery.

Cataract surgery is the most common ophthalmological surgical procedure, and it is predicted that the number of surgeries will increase significantly in the future. However, little is known about the recovery after surgery. The first aim of this study was to evaluate the prevalence, severity and duration of pain and other ocular discomfort symptoms experienced after cataract surgery. The other objectives were to identify the factors associated with lower postoperative patient satisfaction and to measure the effect of cataract surgery on patients' health-related quality of life (HRQoL) and visual function in everyday life. The study design was a prospective follow-up study. The course of the recovery and the presence of ocular symptoms were evaluated by interviewing the patients via a questionnaire at 1 day, 1 week, 6 weeks and one year after surgery The visual functioning in everyday life was measured with Visual Functioning Index VF-7 and Catquest-9SF-questionnaires and furthermore the HRQoL was measured with the 15D-instrument before surgery and at 12 months after surgery. The patients returned the questionnaires by mail and were interviewed in the hospital on the day of the surgery. The same patients filled-in all the questionnaires. The patient reports were used to collect the data on medical history. A total of 303 patients were approached at Kuopio University Hospital in 2010-2011 and of these 196 patients were eligible and willing to participate, with postoperative data being available from 186 (95%) patients. A systematic review article was included in the study procedure and it revealed the wide range in the reported incidence of postoperative ocular pain. Some of the identified randomized controlled studies reported no or only minor pain whereas in some studies significant pain or pain lasting for several weeks has been described in more than 50% of the study patients. In the present study setting, pain was reported by 34% during the first postoperative hours and by approximately 10% of patients during the first six weeks after surgery. During the early recovery in the hospital, only a minority of the patients reporting pain were provided with pain medication. The ocular discomfort symptoms such as itchiness, burning, foreign-body sensation and tearing were common both before (54%) and after surgery (38-52%). These symptoms can also be described as painful symptoms and are often difficult to distinguish from ocular pain. The symptoms are also typical of ocular surface disease, and some patients may benefit from the postoperative administration of tear substitutes. The patients reporting postoperative ocular symptoms were less satisfied with the treatment outcome at 12 months after surgery (p = 0.001) compared to the patients who experienced no symptoms. Those patients reporting less disability in visual functioning before surgery were more satisfied than patients with more reported disability. The HRQoL improved significantly after cataract surgery (p = 0.002). However, when compared to an age-and gender-standardized control population, in cataract subjects the HRQoL remained slightly worse both before and at 12 months after surgery.

Health-related quality of life after cataract surgery with the phacoemulsification technique and intraocular lens implantation.

PURPOSE: Disease-specific instruments have shown significant gains in measuring health-related quality of life (HRQoL) in subjects having cataract surgery. However, the usage of generic instruments has resulted in conflicting evidence. METHODS: In this prospective study, we have evaluated the impact of cataract surgery on subjects' HRQoL measured with a 15-dimension generic instrument, the 15D. The HRQoL of cataract subjects was compared with that of an age- and gender-standardized sample of the general population in Finland. A total of 152 subjects (mean age 74 years, 66% females) with a first-eye cataract surgery completed the 15D questionnaire both before and 12 months after cataract surgery. RESULTS: When compared with the general population, cataract subjects had much lower HRQoL at baseline (mean difference 0.037 (95% CI: 0.020, 0.054), p < 0.001). At 12 months after cataract surgery, the overall utility index improved from the mean of 0.837 to 0.855 (mean difference 0.018 (95% CI: 0.007, 0.029), p = 0.002). Significant improvement was observed on the following five dimensions: seeing, moving, hearing, usual activities and discomfort/symptoms in the 15D questionnaire. CONCLUSION: Our data indicate that at 12 months after first-eye cataract surgery, patients' HRQoL is slightly better than that before surgery. However, patients' postoperative HRQoL may remain lower than that of an age-and gender-standardized control population.

A prospective study on postoperative pain after cataract surgery.

PURPOSE: To evaluate postoperative pain and early recovery in cataract patients. PATIENTS AND METHODS: A total of 201 patients who underwent elective first eye cataract extraction surgery were enrolled, and 196 were included in the final analysis. The study design was a single-center, prospective, follow-up study in a tertiary hospital in eastern Finland. Postoperative pain was evaluated with the Brief Pain Inventory at four time points: at baseline, and at 24 hours, 1 week, and 6 weeks postsurgery. RESULTS: Postoperative pain was relatively common during the first hours after surgery, as it was reported by 67 (34%) patients. After hospital discharge, the prevalence decreased; at 24 hours, 1 week, and 6 weeks, 18 (10%), 15 (9%) and 12 (7%) patients reported having ocular pain, respectively. Most patients with eye pain reported significant pain, with a score of ≥4 on a pain scale of 0-10, but few had taken analgesics for eye pain. Those who had used analgesics rated the analgesic efficacy of paracetamol and ibuprofen as good or excellent. Other ocular irritation symptoms were common after surgery; as a new postoperative symptom, foreign-body sensation was reported by 40 patients (22%), light sensitivity by 29 (16%), burning by 15 (8%), and itching by 15 (8%). CONCLUSION: Moderate or severe postoperative pain was relatively common after cataract surgery. Thus, all patients undergoing cataract surgery should be provided appropriate counseling on pain and pain management after surgery.

Postoperative pain after cataract surgery.

Cataract extraction surgery is the most common surgical procedure, but knowledge of postoperative pain related to cataract surgery is sparse. In this systematic review, the incidence, prevalence, and management of pain after phacoemulsification surgery were identified using PubMed and Scopus. Selected studies were restricted to randomized controlled trials with interventions on postoperative inflammation and pain. Data from 105 articles were extracted and 21 studies met the final inclusion criteria. Most studies reported no or only mild postoperative pain, but some reported moderate and severe pain and pain lasting several weeks. The interventions consisted of drug therapy including topical nonsteroidal antiinflammatory drugs, corticosteroids, paracetamol, perioperative intraocular injections, eye pads used after surgery, and various surgical techniques. The reviewed literature indicates that cataract surgery is associated with significant postoperative pain in some patients, who should be provided with appropriate counseling and pain treatment.