OBJECTIVES: To assess the benefits and harms of TENS for managing pain in people with SCD who experience pain crises or chronic pain (or both).
SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Register, comprising of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched online trial registries and the reference lists of relevant articles and reviews. Date of the last search: 26 Febraury 2020.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs, where TENS was evaluated for managing pain in people with SCD.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility of the trials identified by the literature searches according to the inclusion criteria. Two review authors then independently extracted data, assessed for risk of bias using the Cochrane standard tool and rated the quality of evidence using the GRADE guidelines.
MAIN RESULTS: One double-blind cross-over RCT with 22 participants with SCD (aged 12 to 27 years) was eligible for inclusion. Following stratification into four pain crises severity grades, participants were then randomised to receive TENS or placebo (sham TENS). The trial was concluded after 60 treatment episodes (30 treatment episodes of each treatment group). There is a lack of clarity regarding the trial design and the analysis of the cross-over data. If a participant was allocated to TENS treatment for an episode of pain and subsequently returned with a further episode of a similar degree of pain, they would then receive the sham TENS treatment (cross-over design). For those experiencing a pain episode of a different severity, it is not clear whether they were re-randomised or given the alternate treatment. Reporting and analysis was based on the total number pain events and not on the number of participants. It is unclear how many participants were crossed over from the TENS group to the sham TENS group and vice versa. The trial had a high risk of bias regarding random sequence generation and allocation concealment; an unclear risk regarding the blinding of participants and personnel; and a low risk regarding the blinding of the outcome assessors and selective outcome reporting. The trial was small and of very low quality; furthermore, given the issue with trial design we were unable to quantitatively analyse the data. Therefore, we present only a narrative summary and caution is advised in interpreting the results. In relation to our pre-defined primary outcomes, the included trial did not report pain relief at two to four weeks post intervention. The trial authors reported that no difference was found in the changes in pain ratings (recorded at one hour and four hours post intervention) between the TENS and the placebo groups. In relation to our secondary outcomes, the analgesic usage during the trial also did not show any difference between groups. Given the quality of the evidence, we are uncertain whether TENS improves overall satisfaction as compared to sham TENS. The ability to cope with activities of daily living was not evaluated. Regarding adverse events, although one case of itching was reported in the TENS group, the site and nature of itching was not clearly stated; hence it cannot be clearly attributed to TENS. Also, two participants receiving 'sham' TENS reported a worsening of pain with the intervention.
AUTHORS' CONCLUSIONS: Since we have only included one small and very low-quality trial, with a high risk of bias across several domains, we are unable to conclude whether TENS is harmful or beneficial for managing pain in people with SCD. There is a need for a well-designed, adequately-powered, RCT to evaluate the role of TENS in managing pain in people with SCD.
OBJECTIVE: The aim of this study was to determine and evaluate the trajectory of surgical wound pain from day 1 to day 14 after posterior spinal fusion (PSF) surgery in patients with adolescent idiopathic scoliosis (AIS).
SUMMARY OF BACKGROUND DATA: Information regarding how the postoperative pain improves with time offers invaluable information not only to the patients and parents but also to assist the clinician in managing postoperative pain.
METHODS: AIS patients who were planned for elective PSF surgery from September 2015 to December 2015 were prospectively recruited into this study. All patients underwent a similar pain management regimen with patient-controlled anesthesia (PCA) morphine, acetaminophen, celecoxib, and oxycodone hydrochloride.
RESULTS: A total of 40 patients (36 F:4 M) were recruited. The visual analogue score (VAS) pain score was highest at 12 hours postoperation (6.0 ± 2.3). It reduced to 3.9 ± 2.2 (day 4), 1.9 ± 1.6 (day 7), and 0.7 ± 1.1 (day 14). The total PCA usage in all patients was 12.4 ± 9.9 mg (first 12 hours), 7.1 ± 8.0 mg (12 to 24 hours), 5.6 ± 6.9 (24-36 hours), and 2.1 ± 6.1 mg (36-48 hours). The celecoxib capsules usage was reducing from 215.0 ± 152.8 mg at 24 hours to 55.0 ± 90.4 mg on day 14. The acetaminophen usage was reducing from 2275 ± 1198 mg at 24 hours to 150 ± 483 mg at day 14. Oxycodone hydrochloride capsules consumption rose to the peak of 1.4 ± 2.8 mg on day 4 before gradually reducing to none by day 13.
CONCLUSION: With an adequate postoperation pain regimen, significant pain should subside to a tolerable level by postoperative day 4 and negligible by postoperative day 7. Patient usually can be discharged on postoperative day 4 when the usage of PCA morphine was not required.
LEVEL OF EVIDENCE: 2.
METHODS: A ratio of 25:37:38 of POEs: external phase: surfactants (Tween 80:Span 20, in a ratio 80:20), respectively was selected as the basic composition for the production of a nanocream with ideal properties. Various nanocreams were prepared using phosphate-buffered saline as the external phase at three different pH values. The abilities of these formulae to deliver piroxicam were assessed in vitro using a Franz diffusion cell fitted with a cellulose acetate membrane and full thickness rat skin. These formulae were also evaluated in vivo by comparing their anti-inflammatory and analgesic activities with those of the currently marketed gel.
RESULTS: After eight hours, nearly 100% of drug was transferred through the artificial membrane from the prepared formula F3 (phosphate-buffered saline at pH 7.4 as the external phase) and the marketed gel. The steady-state flux through rat skin of all formulae tested was higher than that of the marketed gel. Pharmacodynamically, nanocream formula F3 exhibited the highest anti- inflammatory and analgesic effects as compared with the other formulae.
CONCLUSION: The nanocream containing the newly synthesized POEs was successful for trans-dermal delivery of piroxicam.