Effects of aromatherapy on patient satisfaction with procedural abortion at less than 10 weeks' gestation: A randomized controlled trial.

OBJECTIVES: This study aimed to compare satisfaction with procedural abortion prior to 10 weeks' gestation in patients randomized to lavender essential oil aromatherapy vs placebo (jojoba oil). STUDY DESIGN: This randomized trial compared lavender aromatherapy vs placebo in patients undergoing procedural abortion <10 weeks' gestation. Participants self-administered and inhaled oil during their procedures. Our primary outcome was composite mean score on the Iowa Satisfaction with Anesthesia Scale. Participants completed the State-Trait Anxiety Inventory, a visual analog scale reporting maximum procedural pain, and reported postprocedure aromatherapy acceptability. RESULTS: We analyzed 112 participants randomized to aromatherapy (n = 57) vs placebo (n = 55). Baseline characteristics were similar between groups. We found no difference in overall satisfaction (mean Iowa Satisfaction with Anesthesia Scale scores aromatherapy: 0.72 ± 0.96 vs placebo: 0.46 ± 0.98, p = 0.17) or maximum procedural pain (median visual analog scale score aromatherapy: 65 [range: 4-95] vs placebo: 63 [range: 7-97], p = 0.91). Independent predictors of satisfaction included the use of oral sedation (B: 0.36; 95% CI: 0.04-0.69), state anxiety (B: -0.45; 95% CI: -0.79 to -0.10), and maximum procedural pain (B: -0.17; 95% CI: -0.25 to -0.09). The aromatherapy participants were significantly more likely to have found inhaling scented oil helpful during their procedure (71.9% vs 45.5%; p = 0.005) and would recommend it to a friend who needed a procedural abortion (86.0% vs 56.4%; p = 0.0005) compared to those in the placebo group. Additionally, patients in the aromatherapy group were significantly more likely to agree with the statement, "If I need another procedural abortion, I would want to inhale scented oil during my procedure" (87.7% vs 70.9%; p = 0.03). CONCLUSIONS: The adjunctive use of lavender aromatherapy during first-trimester procedural abortion does not improve satisfaction with anesthesia but is highly valued by patients. IMPLICATIONS: Oral opioids as an adjunct to standard analgesics during procedural abortion (ibuprofen and paracervical block) do not decrease pain, and nonopioid options are lacking. Given current limited anesthesia options, aromatherapy could serve as an affordable and acceptable nonopioid adjunct to current standard of care during procedural abortion. GOV IDENTIFIER: NCT04969900.

Evaluation of procedural pain for neonates in a neonatal intensive care unit: a single-centre study.

BACKGROUND: To evaluate the procedural pain experienced by neonates in a neonatal intensive care unit (NICU) setting and determine the corresponding pain grades. METHODS: Two experienced nurses independently used the Neonatal Infant Pain Scale (NIPS) to evaluate the neonatal pain during procedures taking place in the tertiary NICU and two level-two neonatal care units in the Children's Hospital of Zhejiang University School of Medicine. The mean and distribution of NIPS pain scores and the corresponding pain grades of participants when experiencing clinical painful procedures were analysed. RESULTS: A total of 957 neonates exposed to 15 common clinical painful procedures were included in the study. The clinical painful procedures experienced by 957 participants could be divided into three groups: severe pain (NIPS score 5-7: peripheral intravenous cannulation, arterial catheterisation, arterial blood sampling, peripherally inserted central catheter placement and nasopharyngeal suctioning), mild to moderate pain (NIPS score 3-4: finger prick, intramuscular injection, adhesive removal, endotracheal intubation suctioning, heel prick, lumbar puncture and subcutaneous injection) and no pain to mild pain (NIPS score 0-2: gastric tube insertion, enema and intravenous injection). CONCLUSIONS: The neonatal pain response to clinical procedures in NICU had certain pattern and preintervention drug analgesia could be taken for painful procedures with clustered high NIPS pain scores. Meanwhile, full coverage non-drug pain relief measures could be taken for procedures that are with scattered pain scores, and real-time pain evaluation should be provided to determine whether further drug analgesia is required.

Effect of Acupressure on Pain during Inferior Alveolar Nerve Block Injection in Children Aged 5-10 Years Old - An Experimental Study.

Background: Acupressure, which is related to acupuncture, is a noninvasive therapy suitable for use in children. However, data examining acupressure's effects on the pain of local anesthetic injection in children are sparse. Objectives: The purpose of this study was to evaluate acupressure's effects on the pain of local anesthetic injection in children. Methods: This randomized, double-blind, parallel-group clinical study included 37 5- to 10-year-olds who had an inferior alveolar nerve block (IANB) for a mandibular extraction and were randomized to one of two groups: acupressure (study group) or non-acupressure (control group). The Wong-Baker FACES Pain Rating Scale (WBFPS) and the Sound, Eye, Motor (SEM) scale were utilized for subjective and objective pain assessment during injection. Results: The objective and subjective assessment of pain during injection significantly differed between the groups, with the acupressure group displaying lower scores. Conclusion: Acupressure at the extra one point (EX-HN1) reduced pain during IANB injection in 5- to 10-year-olds and can be used as an adjunct to conventional measures like topical anesthesia to reduce pain.

Virtual reality hypnosis for needle-related procedural pain and fear management in children: a non-inferiority randomized trial.

Needle-related procedures can cause pain and fear in children and may lead to avoidance of future medical care. The aim of this study is to investigate whether virtual reality hypnosis (VRH) is non-inferior to medical hypnosis (MH) by a trained healthcare provider in reducing pain in children. This non-inferiority randomized trial was conducted at a teaching hospital in the Netherlands. Children aged 6 to 18 years were randomized to treatment with VRH or MH. The primary outcome was self-reported pain, using the Wong-Baker FACES Scale (WBFS) with the non-inferiority margin defined as a difference of 1.5 points. Secondary outcomes included observer-reported pain (Numeric Rating Scale), fear (scored by children and observers with the Children's Fear Scale), blood pressure, heart rate, treatment satisfaction, and adverse effects. We randomized 138 children to VRH or MH treatment and included 114 children in the analyses (VRH n = 60, MH n = 54). We found non-inferiority for VRH compared to MH on patient-reported pain (mean difference = - 0.17, 95%CI - 1.01;0.66). Secondary outcomes were comparable between VRH and MH groups. Both treatments scored high on patient satisfaction (VRH median = 9.0, MH median = 10.0, p = 0.512). CONCLUSION: VRH may be an effective and safe treatment option besides MH for reducing patient-reported pain in children during a needle-related procedure. VRH was non-inferior to MH in patient-reported fear and both treatments were comparable in terms of patient-reported fear, observer-reported pain and fear, physical distress, and patient satisfaction. TRIAL REGISTRATION: ICTRP https://trialsearch.who.int/ , trial ID NL9385; date registered: 03/04/2021. WHAT IS KNOWN: • Medical hypnosis is effective in reducing procedural distress in children during needle-related procedures. • Virtual reality (VR) is an audiovisual electronic device that guides users into an immersive three-dimensional environment. WHAT IS NEW: • This study shows that VR hypnosis is non-inferior to medical hypnosis in reducing pain and fear in children undergoing a needle-related procedure. • Both VR hypnosis and medical hypnosis were appreciated highly by children to distract them during needle-related procedures.

Different effects of intravenous and local anesthesia in patients undergoing ultrasound-guided radiofrequency ablation of thyroid nodules: a prospective cohort study.

PURPOSE: To compare the efficacy and safety of intravenous anesthesia (IV) with local anesthesia (LA) in patients undergoing ultrasound (US)-guided radiofrequency ablation (RFA) of thyroid nodules. METHODS: 50 patients with American Society of Anesthesiologists classification grades I-II undergoing US-guided thyroid RFA were enrolled and randomly (1:1) divided into IV (conscious sedation with Ramsay Sedation Scale [RSS] scores of 2-3 with an anesthesiologist) and LA (subcutaneous anesthesia with lidocaine without an anesthesiologist) groups. Pre-, intra- and post-procedural blood pressure (BP) (SBP0/DBP0, SBP1/DBP1, and SBP2/DBP2), intra- and post-procedural pain (NRS1 and NRS2), ablated area volume, treatment time and adverse events were analyzed and compared. RESULTS: Age, sex, weight, number, nature, volume of nodules, and SBP0/DBP0 showed no difference between both groups. 11 and 0 patients' SBP1/DBP1 were elevated in the LA and IV groups. NRS1 differed between both groups. 6 patients in the LA group had moderate or severe pain, but none in the IV group. No between-group difference in SBP2/DBP2, NRS2, ablation completion rate and ablated volume was noted. The median procedure duration differed from 1109 (176) s in IV group and 723 (227) s in LA groups. There was no increased incidence of adverse events in IV group. CONCLUSIONS: IV with RSS scores of 2-3 maintained intra-procedural BP and relieved intra-procedural pain better, without affecting the ablation efficacy and increasing complications. Despite increased treatment time, IV is a potential option for patients undergoing US-guided RFA of thyroid nodules.

Effectiveness of lidocaine spray on radial arterial puncture pain: A randomized double-blind placebo controlled trial.

OBJECTIVE: Radial arterial puncture is a painful procedure. The aim of this study was to evaluate the effect of lidocaine spray (10%) on pain associated with radial artery blood withdrawal for arterial blood gas analysis. METHODS: This randomized, controlled, double-blind study was performed between December 2018 and September 2019. Before radial arterial puncture, 10% lidocaine or placebo spray was applied to each patient by the attending physician, who was blinded with regard to random assignment. The spray was administered six times on the site from a distance of 5 cm. After waiting for 5 min, a radial arterial puncture was performed routinely. The pain levels of patients during radial arterial puncture and 5 min after puncture were evaluated with the visual analog scale (VAS). The Wilcoxon test was used to compare pain scores during puncture. RESULTS: The research was performed with 67 patients (34 patients in the lidocaine group, 33 patients in the placebo group) who were admitted to the emergency department and required ABG analysis. Forty-three patients were men, and 24 were women. The ages of the patients ranged between 19 and 86 years, and the mean (± standard deviation) age was 56.3 ± 16.6 years. Pain levels, as measured by VAS, were significantly lower in the lidocaine group (24.00 mm IQR:[14.75-33.75]) compared with the placebo group (33.00 mm IQR:[22.00-61.50]) during radial arterial puncture (p = 0.011). CONCLUSIONS: The level of pain perceived during radial arterial puncture was significantly lower in those who were administered lidocaine spray. Lidocaine spray application can be used in pain management related to radial arterial puncture.

The Impact of a Music Video on Procedural Pain and State Anxiety.

PURPOSE: Patients with chronic pain and/or spasticity who have an intrathecal targeted drug delivery (TDD) pump require frequent needle access procedures to refill the pump's medication reservoir. Some patients find the access procedure painful and/or anxiety provoking. The purpose of this study was to determine if a nursing intervention of providing a distraction with a music relaxation video during the pump access procedure would reduce patients' pain and state anxiety. DESIGN/METHODS: In this longitudinal, pre-test post-test, quasi-experimental design, patients watched a 13-minute calming music video while the nurse performed the needle access procedure. Data collection instruments included a combination of researcher-developed questionnaires, the Defense & Veterans Pain Rating Scale (DVPRS), and the State Trait Anxiety Inventory (STAI). Pain and anxiety were measured pre- and post-pump refill procedures at baseline with no intervention (T1) and at two subsequent pump refills with the music video intervention (T2 and T3). RESULTS: The sample consisted of 31 adults with chronic pain (n = 28) or spasticity (n = 3). All participants had an implanted pump for at least six months. Specialty trained nurses refilled the participants' pump in their home. The findings support the use of a music video as an effective intervention for reducing participants' perception of pain and anxiety during the pump refill procedure. Neither pre-test pain nor pre-test anxiety scores differed across time. Post-test mean pain scores decreased consistently across time (T1 = 5.55, T2 = 4.42, T3 = 4.23; P = .002). Post-test anxiety scores showed a significant decrease (P <.05) between T1 (M = 37.87) and T2 (M = 30.94) which was not sustained at T3 (M = 35.68, P = .284). Overall, the majority of participants indicated liking the music video intervention. They also expressed interest in using the intervention for future refill procedures or other stressful situations. CONCLUSIONS: The music video was effective in producing a sustained reduction over time of participants' pain during the pump refill procedures; it was most effective in initially reducing participants' state anxiety at the initial intervention visit; however, it did not demonstrate a progressively sustained effect. Participants' opinions about the music video experience were positive.

Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: a randomized controlled trial.

BACKGROUND: Neuropathic pain is characterized by spontaneous painful symptoms. Medical therapies include the use of a capsaicin 8% patch (Qutenza®, Grünenthal Gmbh, Germany), and patients may experience a sharp burning sensation at application and removal of the patch. This study aimed to evaluate the impact of playing a standardized hypnosis recording during application, on the pain and anxiety induced by capsaicin treatment. METHODS: In a randomized, controlled trial, we assessed the benefits of the intervention firstly on pain and secondly on anxiety, as measured using numerical rating scales. All patients had application of the capsaicin patch, including the possibility for the patient to apply a cold patch. Participants were randomly assigned to one of 3 groups, namely the "Standard group" (no intervention), "Hypnosis group", in which a standardized hypnotic message was played during application, or the "Music group" in which relaxing music was played during application of the patch. RESULTS: Sixty-nine patients were included. Overall, there was no significant difference in pain scores between groups (p = 0.355). Compared to standard application, anxiety was significantly lower in the hypnosis group after application (p = 0.007), with no significant difference between the standard and music arms (p = 0.271), or between the hypnosis and music arms (p = 0.423). CONCLUSIONS: Listening to a standardized hypnotic message during application of a capsaicin patch was found to significantly lower anxiety. These findings indicate that the use of a hypnotic message can reduce discomfort and warrant its evaluation in other indications of pain or anxiety during treatment procedures. TRIAL REGISTRATION: NCT02822625 .

A Nationwide Analysis of Cleft Palate Repair: Impact of Local Anesthesia on Operative Outcomes and Hospital Cost.

BACKGROUND: This study investigates the associations between local anesthesia practice and perioperative complication, length of stay, and hospital cost for palatoplasty in the United States. METHODS: Patients undergoing cleft palate repair between 2004 and 2015 were abstracted from the Pediatric Health Information System database. Perioperative complication, length of stay, and hospital cost were compared by local anesthesia status. Multiple logistic regressions controlled for patient demographics, comorbidities, and hospital characteristics. RESULTS: Of 17,888 patients from 49 institutions who met selection criteria, 8631 (48 percent), 4447 (25 percent), and 2149 (12 percent) received epinephrine-containing lidocaine, epinephrine-containing bupivacaine, and bupivacaine or ropivacaine alone, respectively. The use of epinephrine-containing bupivacaine or bupivacaine or ropivacaine alone was associated with decreased perioperative complication [adjusted OR, 0.75 (95 percent CI, 0.61 to 0.91) and 0.63 (95 percent CI, 0.47 to 0.83); p = 0.004 and p = 0.001, respectively]. Only bupivacaine- or ropivacaine-alone recipients experienced a significantly reduced risk of prolonged length of stay on adjusted analysis [adjusted OR, 0.71 (95 percent CI, 0.55 to 0.90); p = 0.005]. Risk of increased cost was reduced in users of any local anesthetic (p < 0.001 for all). CONCLUSIONS: Epinephrine-containing bupivacaine or bupivacaine or ropivacaine alone was associated with reduced perioperative complication following palatoplasty, while only the latter predicted a decreased postoperative length of stay. Uses of epinephrine-containing lidocaine, epinephrine-containing bupivacaine, and bupivacaine or ropivacaine alone were all associated with decreased hospital costs. Future prospective studies are warranted to further delineate the role of local anesthesia in palatal surgery. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

MR-guided microwave ablation of hepatocellular carcinoma (HCC): is general anesthesia more effective than local anesthesia?

BACKGROUND: Percutaneous magnetic resonance-guided (MR-guided) MWA procedures have traditionally been performed under local anesthesia (LA) and sedation. However, pain control is often difficult to manage, especially in some cases when the tumor is large or in a specific location, such as near the abdominal wall or close to the hepatic dome. This study retrospectively compared the results of general anesthesia (GA) and local anesthesia (LA) for MR-guided microwave ablation (MWA) in patients with hepatocellular carcinoma (HCC ≤ 5.0 cm) to investigate whether different anesthesia methods lead to different clinical outcomes. METHODS: The results of the analysis include procedure-related complications, imaging response, and the time to complete two sets of procedures. According to the type of anesthesia, the Kaplan-Meier method was used to compare the local tumor progression (LTP) of the two groups who underwent MR-guided MWA. RESULTS: All patients achieved technical success. The mean ablation duration of each patient in the GA group and LA group was remarkably different (P = 0.012). Both groups had no difference in complications or LTP (both P > 0.05). Notably, the tumor location (challenging locations) and the number of lesions (2-3 lesions) could be the main factors affecting LTP (p = 0.000, p = 0.015). Univariate Cox proportional hazard regression indicated that using different anesthesia methods (GA and LA) was not associated with longer LTP (P = 0.237), while tumor location (challenging locations) and the number of lesions (2-3 lesions) were both related to shorter LTP (P = 0.000, P = 0.020, respectively). Additionally, multivariate Cox regression further revealed that the tumor location (regular locations) and the number of lesions (single) could independently predict better LTP (P = 0.000, P = 0.005, respectively). CONCLUSIONS: No correlation was observed between GA and LA for LTP after MR-guided MWA. However, tumors in challenging locations and the number of lesions (2-3 lesions) appear to be the main factors affecting LTP.

Topical ketamine as a local anesthetic agent in reducing venipuncture pain: A randomized controlled trial.

AIM: Pain control is an important aspect of ED patient management, and there are many different protocols used around the world influenced by both availability of local resources as well as staff competency and experience. This study aims to evaluate the use of topical ketamine in acute pain reduction by directly comparing it to lidocaine-prilocaine (EMLA) cream. MATERIALS AND METHODS: In this randomized clinical trial, 300 adult patients classified as level 4 or 5 by ESI triage system were enrolled. These patients were divided randomly into three groups. The site of venipuncture was covered with 2 g of topical ketamine cream 10% in group one, 2 g of 5% EMLA cream in group two, and finally, in group 3 (control group), was covered with placebo (2 g of cold cream). The primary end point of the study was reported pain severity with secondary end points being onset of local anesthesia as well as any side effects noted. RESULTS: The data gathered showed pain score during venipuncture in both intervention groups were significantly lower when compared to the control group (P < 0.05). However, pain score did not differ between the 2 intervention groups (P = 0.395). There was no statistically significant difference between the ketamine or EMLA in onset of local anesthesia (P = 0.419). We noted itching and irritation was significantly higher in the EMLA group when compared to ketamine(P < 0.05). CONCLUSION: This study showed that local cutaneous ketamine is as effective as EMLA in relieving pain during venipuncture.

The effect of foot reflexology on procedural pain before heel lancing in neonates.

OBJECTIVE: This study was designed to investigate the effect of foot reflexology on alleviating term neonates' invasive pain caused by heel lance. METHODS: In this quasi-experimental study, 60 healthy neonates were recruited and divided into a reflexology group (n=30) and a control (n=30) group. The study design was quasi-experimental since the randomisation method was not used in the assignment of newborns to the groups. While the reflexology group received foot reflexology for an average of 20min before heel lance, the control group received no intervention. The elicited data were analysed using descriptive statistics and independent t-test. RESULTS: The reflexology and the control groups were similar in terms of age, gestational week, Apgar score, weight, height, and sex (P>0.05). The Neonatal infant pain scale (NIPS) scores of the newborns in the reflexology group after the heel lance procedure were found to be significantly lower than those in the control group (P<0.05). It was also found that reflexology had a significant effect on the neonates' heart rate before heel lance (P<0.05) and a borderline effect during heel lance. Moreover, it was observed that the application of foot reflexology shortened the experimental-group neonates' crying periods after the procedural pain (P<0.05). However, reflexology had no statistically significant effect on the duration of heel lance in both groups (P>0.05). CONCLUSION: The application of foot reflexology before invasive procedures, such as heel lance in newborns, is an effective non-pharmacological method for reducing invasive pain. Thus, reflexology could be used to reduce neonates' pain and soothe them during painful procedures such as heel lance.

Hypnotherapy for Procedural Pain and Distress in Children: A Scoping Review Protocol.

OBJECTIVE: Inadequately treated pain and distress elicited by medical procedures can put children at higher risk of acute and chronic biopsychosocial sequelae. Children can benefit from hypnotherapy, a psychologically tailored intervention, as an adjunct to pharmacological agents to address the multiple components of pain and distress. Despite providing evidence on the effectiveness and potential superiority of hypnotherapy to other psychological interventions, research on hypnotherapy for pediatric procedural pain and distress has been predominantly limited to oncology and needle procedures. Plus, there is a lack of reporting of intervention manuals, factors influencing hypnotic responding, pain unpleasantness outcomes, theoretical frameworks, adverse events, as well as barriers and facilitators to the feasibility of delivering the intervention and study procedures. The proposed review aims to map the range and nature of the evidence on hypnotherapy for procedural pain and distress in children to identify gaps in literature and areas requiring further investigation. METHODS: This review will follow the Arksey and O'Malley (2005) methodology and incorporate additional scoping review recommendations by the Joanna Briggs Institute and Preferred Reporting Items for Systematic reviews and Meta-Analyses. Relevant studies will be identified through searching published literature databases (PubMed, Cochrane Library, PsycINFO, Embase, CINAHL, Scopus and Web of Science) and grey literature in addition to hand-searching of reference lists and key journals. Two authors will independently screen titles and abstracts of search results followed by full-texts review against eligibility criteria. CONCLUSION: Findings are anticipated to guide future research and inform the development of tailored hypnotic interventions in children.

Paracervical blocks facilitate timely brachytherapy amidst COVID-19.

PURPOSE: The COVID-19 pandemic presents serious challenges for brachytherapists, and in the time-sensitive case of locally advanced cervical cancer, the need for curative brachytherapy (BT) is critical for survival. Given the high-volume of locally advanced cervical cancer in our safety-net hospital, we developed a strategy in close collaboration with our gynecology oncology and anesthesia colleagues to allow for completely clinic-based intracavitary brachytherapy (ICBT). METHODS AND MATERIALS: This technical report will highlight our experience with the use of paracervical blocks (PCBs) and oral multimodal analgesia (MMA) for appropriately selected cervical ICBT cases, allowing for completely clinic-based treatment. RESULTS: 18 of 19 (95%) screened patients were eligible for in-clinic ICBT. The excluded patient had significant vaginal fibrosis. 38 of 39 intracavitary implants were successfully transitioned for entirely in-clinic treatment utilizing PCBs and oral MMA (97% success rate). One case was aborted due to inadequate analgesia secondary to a significantly delayed case start time (PO medication effect diminished). 95% of patients reported no pain at the conclusion of the procedure. The median (IQR) D2cc for rectum and bladder were 64.8 (58.6-70.2) Gy and 84.1 (70.9-89.4) Gy, respectively. Median (IQR) CTV high-risk D90 was 88.0 (85.6-89.8) Gy. CONCLUSIONS: In a multidisciplinary effort, we have successfully transitioned many ICBT cases to the clinic with the use of PCB local anesthesia and oral multimodality therapy in direct response to the current pandemic, thereby mitigating exposure risk to patients and staff as well as reducing overall health care burden.

Risk of adverse events due to high volumes of local anesthesia during Mohs micrographic surgery.

General guidelines for the maximum amounts of locally injected lidocaine exist; however, there is a paucity of data in the Mohs micrographic surgery (MMS) literature. This study aimed to determine the safety and adverse effects seen in patients that receive larger amounts of locally injected lidocaine. A retrospective chart review of 563 patients from 1992 to 2016 who received over 30 mL of locally injected lidocaine was conducted. Patient records were reviewed within seven postoperative days for complications. The average amount of anesthesia received was 40 mL, and the average patient weight was 86.69 kg. 1.4% of patients had a complication on the day of surgery, and 4.4% of patients had a complication within 7 days of the surgery. The most common complications were excessive bleeding/hematoma formation and wound infection. Only two complications could be attributable to local anesthetics. Gender, heart disease, hypertension, diabetes, and smoking were not significant risk factors for the development of complications. MMS is a safe outpatient procedure for patients that require over 30 mL of locally injected anesthesia. The safety of high volumes of lidocaine extends to patients with risk factors such as heart disease, hypertension, diabetes, and smoking.

Transcutaneous Electrical Nerve Stimulation to Reduce Pain With Medication Abortion: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether high-frequency transcutaneous electrical nerve stimulation (hfTENS) reduces pain during medication abortion. METHODS: We conducted a randomized, placebo-controlled trial. Participants who were undergoing medication abortion with mifepristone and misoprostol through 70 days of gestation either received active 80 Hz hfTENS or sham to use for a minimum of 60 minutes within 8 hours of misoprostol. Maximum pain on an 11-point numerical rating scale at 8 hours after misoprostol was the primary outcome. We estimated 20 per group for 80% power to detect a 2-point difference and up to 10% attrition. Secondary outcomes included a maximum pain score at 24 hours, additional analgesia use, the difference in score before and after treatment, the experience of side effects, abortion outcomes, and acceptability. We collected data at baseline, time of misoprostol (0-hour), 8-hour and 24 hours using real-time electronic surveys, and at follow-up. RESULTS: Between June 2019 and March 2020, we screened 251 patients and randomized 40-20 each to hfTENS or sham-with one postrandomization exclusion and two patients lost to follow-up. Baseline characteristics were similar. Median maximum pain scores at 8 hours were 7.0 (interquartile range 3.0) and 10.0 (interquartile range 3.0) for hfTENS and sham, respectively. The distribution of these scores was lower among hfTENS users compared with sham (mean rank 15.17 vs 22.63, P=.036). High-frequency TENS users also experienced a significant reduction in posttreatment pain score (-2.0 [interquartile range 2.5] vs 0 [interquartile range 1.5], P=.008). We found no statistically significant differences in use of additional analgesia, distribution of maximum pain scores at 24 hours, side effects, or measures of acceptability. CONCLUSION: High-frequency TENS reduced maximum pain scores within 8 hours of misoprostol and reduced pain scores immediately after treatment compared with placebo. High-frequency TENS offers an effective nonpharmacologic option for pain management during medication abortion. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03925129.