Nebulized analgesia during laparoscopic appendectomy (NALA): A randomized triple-blind placebo controlled trial.

PURPOSE: Postoperative pain remains a considerable concern for patients and families. We assessed whether nebulized ropivacaine reduces morphine consumption and pain after laparoscopic appendectomy for uncomplicated appendicitis in children. METHODS: Patients 7-17 years old with uncomplicated appendicitis were randomized to ropivacaine (intervention arm) or saline nebulization (placebo arm) at the onset of laparoscopy. Nonconsenting individuals were treated with standard care and invited to provide clinical data (baseline arm). The primary outcome was in-patient morphine utilization. Secondary outcomes included pain scores at multiple time-points, markers of recovery, operative times, and surgeon satisfaction. The trial was registered (NCT02624089). RESULTS: Study enrollment was 116 patients over a 1-year period: Intervention (n = 43), Placebo (n = 39), Baseline (n = 34). No differences in baseline characteristics were noted between groups. No difference was noted in overall in-patient morphine consumption between randomized groups (0.31 vs. 0.35 mg/kg, p = 0.42) or between ropivacaine and baseline (0.31 vs. 0.277 mg/kg, p = 0.62). Although operative times were comparable between groups, 63% of surgeon respondents felt that nebulization obscured visualization. CONCLUSION: Nebulized ropivacaine did not reduce postoperative morphine consumption or pain scores after laparoscopic appendectomy for simple appendicitis in children. Given that it decreases visualization and likely increases costs, nebulized administration of intraperitoneal analgesia does not appear warranted in this context. TYPE OF STUDY: Treatment study. LEVEL OF EVIDENCE: Level I.

A randomized, controlled trial comparing long-term cosmetic outcomes of traumatic pediatric lacerations repaired with absorbable plain gut versus nonabsorbable nylon sutures.

OBJECTIVES: To show that the use of absorbable sutures in pediatric traumatic lacerations affords good long-term cosmesis and no increase in complications (infection, dehiscence rates, and need for surgical scar revision) when compared with wounds sutured with nonabsorbable sutures. METHODS: This was a randomized clinical trial conducted in a pediatric emergency department. Patients 1-18 years of age who presented to the emergency department with lacerations < 12 hours old were recruited between January 1999 and December 2001. Exclusion criteria were the following: wounds that could be approximated by tissue adhesives, animal/human bites, gross contamination, puncture/crush wounds, wounds crossing joints, lacerations of tendon/nerve/cartilage, collagen vascular disease, immunodeficiency, diabetes mellitus, bleeding disorder, and scalp lacerations. Patients were randomized into one of two groups: those receiving absorbable plain gut sutures (group A) and those receiving nonabsorbable nylon sutures (group NA). Board-eligible/certified pediatric emergency physicians or clinical fellows performed laceration repair in a standardized approach. All wounds were reevaluated within ten days by a single research nurse who assessed the wounds using a previously validated wound evaluation score (WES) composed of six items (presence of step-off, contour irregularities, margin separation, edge inversion, extensive distortion, and overall cosmetic appearance). A score of 6/6 was considered optimal. The study nurse also noted the presence of infection and dehiscence. The patients were then seen by a single blinded plastic surgeon at four or five months who evaluated the wound using a previously validated visual analog scale of cosmesis (VAS). In addition, the surgeon repeated the WES and assessed the need for surgical scar revision. RESULTS: A total of 147 patients were eligible, and 52 patients declined to participate. Of the 95 patients enrolled, 50 were randomized to group A and 45 to group NA. The two groups had similar ages, gender distributions, rates of use of sedation or steri-strips, wound lengths and widths, mechanisms of injury, and wound locations. At the short-term follow-up, no difference was found in the proportion of optimal WES scores between group A (63% of patients) and group NA (49% of patients) (relative risk = 0.73; 95% confidence interval [95% CI] = 0.45 to 1.17). No difference was found in the rates of infection and dehiscence between the two groups. Sixty-three of the 95 patients presented for long-term follow-up. The groups remained similar with respect to patient and wound characteristics as well as wound location. The average VAS score at four months was 79 (95% CI = 73 to 85) for group A and 66 (95% CI = 55 to 76) for group NA. In addition, no differences were found in the proportion of optimal WES between group A (36% of patients) and group NA (28% of patients) at four months (relative risk = 0.88; 95% CI = 0.62 to 1.26). Surgical scar revision was recommended for only three patients, of whom two were in group A. No patients chose to have their scars revised. No differences were found between group A and group NA for the rates of dehiscence (2% vs. 11%; p = 0.07) and infection (0 vs. 2; p = 0.3). CONCLUSIONS: The use of plain catgut absorbable sutures in the repair of traumatic lacerations in children appears to be an acceptable alternative to nonabsorbable sutures because the long-term cosmetic outcome seems to be at least as good. In this study, plain gut suture material seemed to provide slightly better cosmesis. In addition, no difference was found in the rate of dehiscence or infection between the groups.