Material & Methods: A parallel design, prospective randomized double masked placebo controlled clinical trial in which hundred patients more than 18 years of age with stable myopia of more than 1.5 diopters were enrolled. Preoperative visual acuity, corneal thickness and detailed slit lamp biomicroscopic examination were done. Patients were instructed to instill one drop of allotted drug (either ascorbic acid or placebo) four times daily along with the routine post LASIK medications for the three consecutive post-operative days. Visual acuity, corneal thickness, slit lamp biomicroscopy for corneal wound and interface, tolerance to drug and relief of pain was assessed on day one and day seven. Results were evaluated by preset questionnaires and comprehensive clinical examination on the day one and day seven. There were no significant differences on day one and day seven in visual acuity, corneal clarity, corneal thickness and corneal wound healing (p>0.05). Ascorbic acid for the first three days postoperatively after LASIK did not show any immediate clinical benefit over placebo.
Analgesic effects of ibuprofen immediate-release/extended-release (IR/ER) 600-mg tablets were evaluated in 2 randomized, double-blind, placebo-controlled dental pain studies. Patients 16-40 years old with moderate-severe pain following third-molar extraction received single-dose ibuprofen 600 mg IR/ER (formulation A or B), naproxen sodium 220 mg, or placebo (2:2:2:1; study 1) or 4 doses of ibuprofen 600 mg IR/ER (formulation A) or placebo (1:1; study 2). In study 1 (n = 196), mean (standard deviation [SD]) time-weighted sum of pain intensity difference scores for placebo, ibuprofen IR/ER A, ibuprofen IR/ER B, and naproxen, respectively, were 0.05 (9.2), 16.87 (9.4), 17.34 (10.5), and 12.66 (10.0) over 0-12 hours and -0.03 (4.1), 6.57 (4.4), 7.14 (5.2), and 5.14 (5.0) over 8-12 hours (all P < .001 vs placebo). In study 2 (n = 106), mean (SD) time-weighted sum of pain relief and pain intensity difference scores were 18.2 (20.0) versus 41.5 (21.0) at 0-12 hours and 10.3 (12.0) versus 18.4 (12.1) at 8-12 hours for placebo versus ibuprofen IR/ER, respectively (P < .001 for both); efficacy was sustained over each of the four 12-hour dosing intervals with ibuprofen. Gastrointestinal adverse events predominated with placebo both after study medication administration and after rescue medication use, if applicable. Ibuprofen 600 mg IR/ER provided safe and effective analgesia after single and multiple doses.
PURPOSE: We designed a randomized double-blind placebo-controlled trial to assess the role of a single prophylactic dose of vitamin C (2 g) po in reducing the consumption of opioids postoperatively in patients undergoing laparoscopic cholecystectomy.
METHODS: Eighty adult patients were allocated to receive 2 g vitamin C po or placebo approximately one hour prior to induction of anesthesia. Following laparoscopic cholecystectomy, patients received morphine patient-controlled analgesia for 24 hr. The following data were assessed postoperatively in the postanesthesia care unit at two, four, six, 12, and 24 hr: morphine consumption, verbal numerical rating scale scores for incisional pain and nausea/vomiting, and pruritus and sedation scores. The primary outcome measure was 24-hr morphine consumption. Patient satisfaction was assessed before hospital discharge.
RESULTS: Morphine consumption was significantly lower in the vitamin C group vs the placebo group [16.2 (10.7) and 22.8 (13.8) mg, respectively; difference = 6.6 mg; 95% confidence interval, 1.1 to 12.1 mg; P = 0.02]. There was no difference in pain scores or side effects between the two groups. Satisfaction scores were similar in both groups.
CONCLUSION: Our study showed that supplementation with vitamin C (2 g) po decreased morphine consumption in the postoperative period in patients undergoing laparoscopic cholecystectomy.
Complex regional pain syndrome (CRPS) type I may occur as complication after any type of surgery for basal joint arthritis of the thumb. We investigated prospectively in an ongoing study our results after a fully standardized treatment with a total joint prosthesis under vitamin C prophylaxis.Patients with trapeziometacarpal arthritis stage II or III according to Dell, and no benefit from conservative treatment, were selected to undergo joint replacement with a semi-constrained hydroxyapatite coated prosthesis.First web opening and visual analogue scale (VAS) scores for pain, activities of daily living (ADL) and satisfaction were taken pre and postoperatively. Vitamin C 500 mg daily was started two days prior to surgery during 50 days as prevention for CRPS. Post-operative treatment was functional.We performed 40 implantations for trapeziometacarpal arthritis in 34 patients (mean age 60.8 years; 27 females, 7 males) with a mean follow-up of 44 months. Operations were performed in day care under regional (or general) anesthesia.First web opening increased with 15.4 degrees and there was a significant improvement for pain, ADL and satisfaction as well (p = 0.000). Patient satisfaction was strongly associated with the amount of pain reduction. According to the Veldman and IASP criteria, there were no cases of CRPS.The overall complication rate for this procedure is high. Literature reports 5 cases of CRPS after 38 operations with the same implant (13%). We advise vitamin C as prophylaxis against CRPS in trapeziometacarpal joint replacement.
BACKGROUND: Combination analgesics may offer improved analgesic efficacy, particularly for moderate to severe pain. OBJECTIVE: This study evaluated the analgesic benefits of concurrent ibuprofen and paracetamol compared with each drug used alone in the management of acute postoperative dental pain. METHODS: Healthy patients aged 16 to 40 years undergoing surgical removal of 3 to 4 impacted molars (total impaction score >/=9) were enrolled in this randomized, double-blind, placebo-controlled, parallel-group, single-dose, 2-center, modified factorial US study. Patients were randomly assigned in a ratio of 2:1:2:1:1 to ibuprofen 400 mg/paracetamol 1000 mg, ibuprofen 200 mg/ paracetamol 500 mg, ibuprofen 400 mg, paracetamol 1000 mg, or placebo when postoperative pain reached moderate to severe intensity. The primary efficacy end point was the sum of pain relief and pain intensity differences from 0 to 8 hours (SPRID8). Several secondary end points were also measured, including total pain relief (TOTPAR), sum of pain intensity differences (SPID), and SPID on the visual analog scale (SPID VAS) at various time points. Other analgesic efficacy measures included peak effect, onset and duration of effect, and patients' overall assessment of treatment. The tolerability of study medications was assessed in terms of the frequency and nature of adverse events, which were assessed with standard questions, as well as changes from baseline in vital signs. RESULTS: A total of 234 patients were randomly assigned to treatment and included in the intent-to- treat population. The patients were predominantly female (74.4% [174/234]) and white (76.5% [179/234]); mean (SD) age was 20.8 (3.1) years and weight was 69.1 (16.5) kg. For SPRID8, the group treated with ibuprofen 400 mg/paracetamol 1000 mg had significantly better mean scores compared with ibuprofen alone (P < 0.001), paracetamol alone (P < 0.001), and ibuprofen 200 mg/paracetamol 500 mg (P = 0.02). The group taking ibuprofen 200 mg/paracetamol 500 mg achieved significantly better mean SPRID8 scores than paracetamol alone (P = 0.03), but not ibuprofen alone (P = NS). Ibuprofen 400 mg/paracetamol 1000 mg was associated with significantly better scores than was single-agent therapy for TOTPAR, SPID, and SPID VAS at all time intervals and for SPRID from 4 to 6 hours (all, P < 0.001). Pairwise comparisons found statistically significant differences in favor of all active treatments versus placebo for virtually all efficacy end points, thereby supporting assay sensitivity. Adverse events were similar across treatments; the most frequent were nausea (26.1% [61/234]), vomiting (18.8% [44/234]), headache (10.3% [24/234]), and dizziness (8.1% [19/234]). CONCLUSION: Concurrent ibuprofen and paracetamol appeared to provide significantly better analgesic efficacy compared with ibuprofen or paracetamol alone for acute postoperative dental pain in these adolescents and adults.
Operative and conservative treatment of wrist fractures might lead to complex regional pain syndrome (CRPS) type I. In our multicenter dose response study in which patients with distal radial fractures were randomly allocated to placebo or vitamin C in a daily dose of 200mg, 500mg or 1500mg during 50 days, an operated subgroup was analyzed. 48 (of 427) fractures) were operated (11.2%). Twenty-nine patients (60%) were treated with external fixation, 14 patients (29%) with K-wiring according to Kapandji and five patients (10%) with internal plate fixation. The 379 remaining patients were treated with a plaster. In the operated group of patients who received vitamin C no CRPS (0/37) was seen in comparison with one case of CRPS (Kapandji technique) in the operated group who received placebo (1/11 = 9%, p=.23). There was no CRPS after external fixation. In the conservatively treated group 17 cases of CRPS (17/379 = 4.5%) occurred in comparison with one in case of CRPS in the operated group (1/48 = 2.1%, p=.71). External fixation doesn’t necessarily lead to a higher incidence of CRPS in distal radial fractures. Vitamin C may also play a role in this. This subgroup analysis in operated distal radial fractures showed no CRPS occurrence with vitamin C prophylaxis.
BACKGROUND: The public health cost impact of complex regional pain syndrome type I (CRPS I) is considerable in both emergency and scheduled orthopaedic surgery. We proposed to assess the effectiveness of vitamin C in prevention of CRPS I in foot and ankle surgery.
METHODS: We carried out a "before-after" quasi-experimental study comparing two chronologically successive groups without (Group I: July 2002-June 2003) and with (Group II: July 2003-June 2004) preventive 1g daily vitamin C treatment. All patients having surgery on the foot or ankle were enrolled, with the exception of diabetic foot cases. Several factors were analysed: sex, age, type of pathology, history of CRPS I, psychological context, tourniquet time, and cast immobilisation time.
RESULTS: 420 feet (392 patients) were included in the study: 185 in Group I, 235 in Group II. CRPS I occurred in 18 cases in Group I (9.6%) and 4 cases in Group II (1.7%) (p<10(-4)), with history of CRPS I as a significantly correlated factor (relative risk=10.4). The psychological context (anxio-depressive state) showed a (sub-significant) tendency to increase the risk of CRPS I (relative risk=2.6).
CONCLUSION: Vitamin C has been shown to be effective in preventing CRPS I secondary to wrist fracture, but few data are available with respect to foot and ankle cases. The present study demonstrates the effectiveness of vitamin C in preventing CRPS I of the foot and ankle-a frequent complication in our control group (9.6%). The authors recommend preventive management by vitamin C.
Patients with trapeziometacarpal joint arthritis stage II or III (according to Dell) and no benefit from non-operative therapy were selected to undergo joint arthroplasty. We performed 32 arthroplasties for first carpometacarpal arthritis in 27 patients using a cementless total trapeziometacarpal joint prosthesis. We undertook a prospective cohort study and evaluated the clinical results of total joint arthroplasty after an average of 39 months. Visual analogue scale (VAS) scores for pain, daily activities (ADL) and satisfaction were taken pre- and postoperatively, and the first web opening was measured. First web opening improved significantly as did pain, ADL and patient satisfaction. Surgery of arthritis of the first carpometacarpal joint can be complicated by complex regional pain syndrome (CRPS) type I. In all our patients Vitamin C 500 mg daily was started two days before surgery and continued during 50 days. There were no cases of CRPS under vitamin C prophylaxis. These results justify further investigation in a randomised clinical trial.
BACKGROUND: Complex regional pain syndrome type I is treated symptomatically. A protective effect of vitamin C (ascorbic acid) has been reported previously. A dose-response study was designed to evaluate its effect in patients with wrist fractures.
METHODS: In a double-blind, prospective, multicenter trial, 416 patients with 427 wrist fractures were randomly allocated to treatment with placebo or treatment with 200, 500, or 1500 mg of vitamin C daily for fifty days. The effect of gender, age, fracture type, and cast-related complaints on the occurrence of complex regional pain syndrome was analyzed.
RESULTS: Three hundred and seventeen patients with 328 fractures were randomized to receive vitamin C, and ninety-nine patients with ninety-nine fractures were randomized to receive a placebo. The prevalence of complex regional pain syndrome was 2.4% (eight of 328) in the vitamin C group and 10.1% (ten of ninety-nine) in the placebo group (p=0.002); all of the affected patients were elderly women. Analysis of the different doses of vitamin C showed that the prevalence of complex regional pain syndrome was 4.2% (four of ninety-six) in the 200-mg group (relative risk, 0.41; 95% confidence interval, 0.13 to 1.27), 1.8% (two of 114) in the 500-mg group (relative risk, 0.17; 95% confidence interval, 0.04 to 0.77), and 1.7% (two of 118) in the 1500-mg group (relative risk, 0.17; 95% confidence interval, 0.04 to 0.75). Early cast-related complaints predicted the development of complex regional pain syndrome (relative risk, 5.35; 95% confidence interval, 2.13 to 13.42).
CONCLUSIONS: Vitamin C reduces the prevalence of complex regional pain syndrome after wrist fractures. A daily dose of 500 mg for fifty days is recommended.
Material & Methods: A parallel design, prospective randomized double masked placebo controlled clinical trial in which hundred patients more than 18 years of age with stable myopia of more than 1.5 diopters were enrolled. Preoperative visual acuity, corneal thickness and detailed slit lamp biomicroscopic examination were done. Patients were instructed to instill one drop of allotted drug (either ascorbic acid or placebo) four times daily along with the routine post LASIK medications for the three consecutive post-operative days. Visual acuity, corneal thickness, slit lamp biomicroscopy for corneal wound and interface, tolerance to drug and relief of pain was assessed on day one and day seven. Results were evaluated by preset questionnaires and comprehensive clinical examination on the day one and day seven. There were no significant differences on day one and day seven in visual acuity, corneal clarity, corneal thickness and corneal wound healing (p>0.05). Ascorbic acid for the first three days postoperatively after LASIK did not show any immediate clinical benefit over placebo.
