scholarly journals Time to intubation with McGrath™ videolaryngoscope versus direct laryngoscope in powered air-purifying respirator: a randomised controlled trial

2021 ◽  
Author(s):  
QY Goh ◽  
SA Lie ◽  
Z Tan ◽  
PYB Tan ◽  
SY Ng ◽  
...  
Keyword(s):  
Tracheal Intubation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Surgical Patients ◽  
Intubation Difficulty ◽  
Direct Laryngoscope ◽  
Significant Difference ◽  
Scale Scores ◽  
Difficulty Scale ◽  
Randomised Controlled

Introduction: During the COVID-19 pandemic, multiple guidelines have recommended the videolaryngoscope for tracheal intubation. However, there is no evidence that videolaryngoscope reduces time to tracheal intubation, which is important for COVID-19 patients with respiratory failure. Methods: To simulate intubation of COVID-19 patients, we randomised 28 elective surgical patients to be intubated with either the McGrath™ MAC videolaryngoscope or the direct laryngoscope by specialist anaesthetists donning 3M™ Jupiter™ powered air-purifying respirators (PAPR) and N95 masks. Primary outcome was time to intubation. Results: The median (IQR) times to intubation were 61s (37–63 s) and 41.5s (37–56 s) in the videolaryngoscope and direct laryngoscope groups respectively (p = 0.35). The closest mean (SD) distances between the anaesthetist and the patient during intubation were 21.6 cm (4.8 cm) and 17.6 cm (5.3 cm) in the videolaryngoscope and direct laryngoscope groups, respectively (p = 0.045). There were no significant differences in the median intubation difficulty scale scores, proportion of successful intubation at first laryngoscopic attempt and proportion of intubations requiring adjuncts. Intubations for all the patients were successful with no adverse event. Conclusion: There was no significant difference in the time to intubation by specialist anaesthetists who were donned in PAPR and N95 masks on elective surgical patients with either the McGrath™ videolaryngoscope or direct laryngoscope. The distance between the anaesthetist and patient was significantly further with the videolaryngoscope. The direct laryngoscope could be an equal alternative to videolaryngoscope for specialist anaesthetists when resources are limited or disrupted due to the pandemic.

scholarly journals O04 Clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injection for hip OA: a randomised controlled trial (HIT)

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Zoe Paskins ◽  
Kieran Bromley ◽  
Martyn Lewis ◽  
Gemma Hughes ◽  
Emily Hughes ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Pain Intensity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Hip Pain ◽  
Ultrasound Guided ◽  
Life Years ◽  
Significant Difference ◽  
Randomised Controlled

Abstract Background Evidence of the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis (OA) is limited. The HIT trial compared the clinical and cost-effectiveness of an ultrasound-guided intra-articular hip injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride combined with best current treatment (BCT) with (i) BCT alone (primary objective) and (ii) an USGI of 5ml 1% lidocaine only combined with BCT (EudraCT:2014-003412-37). Methods This was a pragmatic, three-parallel arm, single-blind, randomised controlled trial in adults with moderate-severe painful hip OA recruited from community musculoskeletal services and primary care. Participants were randomised equally to: (1) BCT alone, (2) BCT plus USGI triamcinolone/lidocaine, or (3) BCT plus USGI lidocaine only. Outcomes were collected postally at 2 weeks, 2, 4 and 6 months. The primary outcome was self-reported current hip pain intensity (0-10 numeric rating scale (NRS)) over 6 months (repeated measures analysis). Secondary outcomes included function (WOMAC), and, for cost-utility analysis, general health (EQ-5D-5L) and healthcare utilisation. 204 participants were required to detect a minimum difference of 1 point in mean pain NRS score between arms (1) and (2) with 80% power (5% two-tailed significance level, 15% loss to follow-up). Analysis was by intention-to-treat. Results 199 participants were recruited (43% male, mean age 63 years), 67 to arm (1) and 66 each to arms (2) and (3). Primary outcome completion rates were 95% at 2 weeks, 94% at 2 months, 90% at 4 months, and 89% at 6 months. Greater mean improvement in hip pain intensity (0-10 NRS) over 6 months was seen with BCT plus USGI triamcinolone/lidocaine compared with BCT alone: -1.43 (95%CI -2.15,-0.72). Greater mean improvement in pain intensity was seen at 2 weeks (-3.17; -4.06,-2.28) and 2 months (-1.81;-2.71,-0.92), but not at 4 (-0.86;-1.78,0.05) or 6 months (0.12; -0.80,1.04). Participants treated with BCT plus USGI triamcinolone/lidocaine compared with BCT alone had greater mean improvement in function (WOMAC-F -5.47;(-9.41,-1.53)) over 6 months. There was no statistically significant difference in hip pain intensity over 6 months between BCT plus USGI triamcinolone/lidocaine compared with BCT plus USGI lidocaine (-0.52;-1.21,0.18). There was one possible treatment-related serious adverse event: a participant with no signs of infection at randomisation died from endocarditis four months after USGI triamcinolone/lidocaine. BCT plus USGI triamcinolone/lidocaine was less costly (mean cost difference per participant £-161.59) and associated with significantly higher quality-adjusted life-years (QALYs) than BCT only over 6 months (mean difference 0.0477 (0.0257,0.0699). Conclusion USGI triamcinolone/lidocaine plus BCT leads to greater improvements in pain and function over 6 months in adults with hip OA than BCT alone, and was highly cost-effective. There was no significant difference in hip pain intensity between the groups receiving USGI triamcinolone/lidocaine and USGI lidocaine only, raising the possibility of a degree of placebo effect. Disclosures Z. Paskins None. K. Bromley None. M. Lewis None. G. Hughes None. E. Hughes None. A. Cherrington None. A. Hall None. M. Holden None. R. Oppong None. J. Kigozi None. K. Stevenson None. A. Menon None. P. Roberts None. G. Peat None. C. Jinks None. N.E. Foster None. C.D. Mallen None. E. Roddy None.

scholarly journals Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

2018 ◽  
Vol 213 (1) ◽  
pp. 404-411 ◽  
Author(s):  
Ulrika Karlsson Stigsdotter ◽  
Sus Sola Corazon ◽  
Ulrik Sidenius ◽  
Patrik Karlsson Nyed ◽  
Helmer Bøving Larsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Significant Difference ◽  
Increasing Demand ◽  
Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

scholarly journals Influence of overstated abstract conclusions on clinicians: a web-based randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018355 ◽  
Author(s):  
Kiyomi Shinohara ◽  
Takuya Aoki ◽  
Ryuhei So ◽  
Yasushi Tsujimoto ◽  
Aya M Suganuma ◽  
...  
Keyword(s):  
Primary Care ◽  
Primary Care Physicians ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Outcome Information ◽  
Significant Difference ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesTo investigate whether overstatements in abstract conclusions influence primary care physicians’ evaluations when they read reports of randomised controlled trials (RCTs)DesignRCT setting: This study was a parallel-group randomised controlled survey, conducted online while masking the study hypothesis.ParticipantsVolunteers were recruited from members of the Japan Primary Care Association in January 2017. We sent email invitations to 7040 primary care physicians. Among the 787 individuals who accessed the website, 622 were eligible and automatically randomised into ‘without overstatement’ (n=307) and ‘with overstatement’ (n=315) groups.InterventionsWe selected five abstracts from published RCTs with at least one non-significant primary outcome and overstatement in the abstract conclusion. To construct a version without overstatement, we rewrote the conclusion sections. The methods and results sections were standardised to provide the necessary information of primary outcome information when it was missing in the original abstract. Participants were randomly assigned to read an abstract either with or without overstatements and asked to evaluate the benefit of the intervention.Outcome measuresThe primary outcome was the participants’ evaluation of the benefit of the intervention discussed in the abstract, on a scale from 0 to 10. A secondary outcome was the validity of the conclusion.ResultsThere was no significant difference between the groups with respect to their evaluation of the benefit of the intervention (mean difference: 0.07, 95% CI −0.28 to 0.42, p=0.69). Participants in the ‘without’ group considered the study conclusion to be more valid than those in the ‘with’ group (mean difference: 0.97, 95% CI 0.59 to 1.36, P<0.001).ConclusionThe overstatements in abstract conclusions did not significantly influence the primary care physicians’ evaluations of the intervention effect when necessary information about the primary outcomes was distinctly reported.Trial registration numberUMIN000025317; Pre-results.

scholarly journals Droperidolv. haloperidol for sedation of aggressive behaviour in acute mental health: Randomised controlled trial

2015 ◽  
Vol 206 (3) ◽  
pp. 223-228 ◽  
Author(s):  
Leonie Calver ◽  
Vincent Drinkwater ◽  
Rahul Gupta ◽  
Colin B. Page ◽  
Geoffrey K. Isbister
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Behavioural Disturbance ◽  
Significant Difference ◽  
Psychiatric Units ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Effective Sedation

BackgroundAgitation and aggression are significant problems in acute psychiatric units. There is little consensus on which drug is most effective and safest for sedation of these patients.AimsTo compare the effectiveness and safety of haloperidolv. droperidol for patients with agitation and aggression.MethodIn a masked, randomised controlled trial (ACTRN12611000565943) intramuscular droperidol (10 mg) was compared with intramuscular haloperidol (10 mg) for adult patients with acute behavioural disturbance in a psychiatric intensive care unit. The primary outcome was time to sedation within 120 min. Secondary outcomes were use of additional sedation, adverse events and staff injuries.ResultsFrom 584 patients, 110 were randomised to haloperidol and 118 to droperidol. Effective sedation occurred in 210 (92%) patients within 120 min. There was no significant difference in median time to sedation: 20 min (interquartile range 15–30, range 10–75) for haloperidolv. 25 min (IQR 15–30, range 10–115) for droperidol (P= 0.89). Additional sedation was used more often with haloperidol (13%v. 5%,P= 0.06), but adverse effects were less common with haloperidol (1%v. 5%,P= 0.12). There were 8 staff injuries.ConclusionsBoth haloperidol and droperidol were effective for sedation of patients with acute behavioural disturbance.

scholarly journals Perioperative haemodynamic therapy for major gastrointestinal surgery: the effect of a Bayesian approach to interpreting the findings of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024256 ◽  
Author(s):  
Elizabeth G Ryan ◽  
Ewen M Harrison ◽  
Rupert M Pearse ◽  
Simon Gates
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Gastrointestinal Surgery ◽  
Evidence Based ◽  
Bayesian Analyses ◽  
Therapy Algorithm ◽  
Significant Difference ◽  
Randomised Controlled ◽  
The Impact

ObjectiveThe traditional approach of null hypothesis testing dominates the design and analysis of randomised controlled trials. This study aimed to demonstrate how a simple Bayesian analysis could have been used to analyse the Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome (OPTIMISE) trial to obtain more clinically interpretable results.Design, setting, participants and interventionsThe OPTIMISE trial was a pragmatic, multicentre, observer-blinded, randomised controlled trial of 734 high-risk patients undergoing major gastrointestinal surgery in 17 acute care hospitals in the UK. Patients were randomly allocated to a cardiac output-guided haemodynamic therapy algorithm for intravenous fluid and inotropic drug administration during and in the 6 hours following surgery (n=368) or to standard care (n=366). The primary outcome was a binary outcome consisting of a composite of predefined 30-day moderate or major complications and mortality.MethodsWe repeated the primary outcome analysis of the OPTIMISE trial using Bayesian statistical methods to calculate the probability that the intervention was superior, and the probability that a clinically relevant difference existed. We explored the impact of a flat prior and an evidence-based prior on our analyses.ResultsAlthough OPTIMISE was not powered to detect a statistically significant difference between the treatment arms for the observed effect size (relative risk=0.84, 95% CI 0.70 to 1.01; p=0.07), by using Bayesian analyses we were able to demonstrate that there was a 96.9% (flat prior) to 99.5% (evidence-based prior) probability that the intervention was superior to the control.ConclusionsThe use of a Bayesian analytical approach provided a different interpretation of the findings of the OPTIMISE trial (compared with the original frequentist analysis), and suggested patient benefit from the intervention. Incorporation of information from previous studies provided further evidence of a benefit from the intervention. Bayesian analyses can produce results that are more easily interpretable and relevant to clinicians and policy-makers.Trial registration numberISRCTN04386758; Post-results.

Evaluation of Tracheal Intubation Difficulty in Patients with Cervical Spine Immobilization 

1999 ◽  
Vol 91 (5) ◽  
pp. 1253-1253 ◽  
Author(s):  
Charles E. Smith ◽  
Anna B. Pinchak ◽  
Tejbir S. Sidhu ◽  
Brian P. Radesic ◽  
Alfred C. Pinchak ◽  
...  
Keyword(s):  
Cervical Spine ◽  
Tracheal Intubation ◽  
Scale Score ◽  
Conventional Group ◽  
P Value ◽  
Success Rates ◽  
Intubation Difficulty ◽  
Fiberoptic Laryngoscope ◽  
Scale Scores ◽  
Difficulty Scale

Background The WuScope is a rigid, fiberoptic laryngoscope designed to facilitate tracheal intubation without the need for head extension. The study evaluated the WuScope in anesthetized patients with neck immobilization. Methods Patients were randomized to one of two groups: those receiving fiberoptic laryngoscopy (WuScope, n = 43) and those receiving conventional laryngoscopy (Macintosh blade, n = 44). Manual in-line stablization of the cervical spine was done during intubation. Seven parameters of intubation difficulty were measured (providing an intubation difficulty scale score): number of operators, number of attempts, number of techniques, Cormack view, lifting force, laryngeal pressure, and vocal cord position. Results Successful intubation occurred in 95% of patients in the fiberoptic group and in 93% of patients in the conventional group. There were no differences in number of attempts. In the fiberoptic group, 79% of patients had an intubation difficulty scale score of 0, representing an ideal intubation: that is, one performed by the first operator on the first attempt using the first technique with full glottic visualization. Only 18% of patients in the conventional group had an intubation difficulty scale score of 0 (P &lt; 0.001). More patients had Cormack grade 3 or 4 views with conventional than with fiberoptic laryngoscopy (39 vs. 2%, P &lt; 0.001). Intubation times in patients with one attempt were slightly longer in the fiberoptic (median, 25th-75th percentiles: 30, 23-53 s) compared with the conventional group (24, 17-30 s, P &lt; 0.05). Corresponding times in patients requiring &gt; one attempt were 155 (range, 112-201) s and 141 (range, 95-186) s in the fiberoptic and conventional groups, respectively (P value not significant). Conclusions Compared with conventional laryngoscopy, tracheal intubation using the fiberoptic laryngoscope was associated with lower intubation difficulty scale scores and better views of the laryngeal aperture in patients with cervical imnmobilization. However, there were no differences in success rates or number of intubation attempts.

scholarly journals Does addition of craving management tools in a stop smoking app improve quit rates among adult smokers? Results from BupaQuit pragmatic pilot randomised controlled trial.

2019 ◽  
Author(s):  
Aleksandra Herbec ◽  
Lion Shahab ◽  
Jamie Brown ◽  
Harveen Kaur Ubhi ◽  
Emma Beard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Point Prevalence ◽  
Management Tools ◽  
Exact Test ◽  
Significant Difference ◽  
Continuous Abstinence ◽  
Randomised Controlled

Introduction: Delivery of craving management tools (CMTs) via smartphone applications (apps) may improve smoking cessation rates, but research on such programmes remainslimited, especially in real-world settings. This study evaluated the effectiveness of adding CMTs in a cessation app (BupaQuit).Methods: The study was a two-arm pragmatic pilot parallel randomised controlled trial, comparing a fully-automated BupaQuit app with CMT with a control app version withoutCMT. A total of 425 adult UK-based daily smokers were enrolled through open online recruitment (February 2015-March 2016), with no researcher involvement, and individually randomised within the app to the intervention (n=208) or control (n=217). The primary outcome was self-reported 14-day continuous abstinence assessed at 4-week follow-up. Secondary outcomes included 6-month point-prevalence and sustained abstinence, and app usage. The primary outcome was assessed with Fisher’s exact test using intent to treat with those lost to follow-up counted as smoking. Participants were not reimbursed.Results: Re-contact rates were 50.4% at 4 weeks and 40.2% at 6 months. There was no significant difference between intervention and control arms on the primary outcome (13.5% vs 15.7%; p=0.58;RR=0.86, 95% Confidence Interval (CI)=0.54-1.36) or secondary cessation outcomes (6-month point prevalence: 14.4% vs. 17.1%, p=0.51;RR=0.85, 95%CI=0.54-1.32; 6-month sustained: 11.1% vs 13.4%, p=0.55,RR=0.83,95%CI=0.50-1.38). Bayes factors supported the null hypothesis (B[0, 0,1.0986]=.20). Usage was similar across the conditions (mean/median logins: 9.6/4 vs. 10.5/5; time spent: 401.8/202s vs. 325.8/209s).Conclusions: The addition of craving management tools did not affect cessation, and the limited engagement with the app may have contributed to this.

scholarly journals 388Investigating the utility of the customised fetal growth chart: a pragmatic randomised controlled trial

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Kristen Gibbons ◽  
Michael Beckmann ◽  
Vicki Flenady ◽  
Glenn Gardenre ◽  
Peter Gray
Keyword(s):  
Randomised Controlled Trial ◽  
Fetal Growth ◽  
Primary Outcome ◽  
Adverse Pregnancy Outcome ◽  
Controlled Trial ◽  
Growth Chart ◽  
Singleton Pregnancy ◽  
Double Blind ◽  
Significant Difference ◽  
Randomised Controlled

Abstract Background To determine if the routine use of a customised fetal growth chart, when compared to a standard growth chart, reduces the risk of adverse pregnancy outcome through increased detection of adverse growth. Methods A double-blind, single centre, randomised controlled trial was conducted. All women with a singleton pregnancy receiving routine antenatal care through hospital clinics were included and randomised to either a standard growth chart (SC) or a customised growth chart (CC). Serial measurements of symphyseal fundal height (SFH) were plotted onto the chart in the electronic clinical record; pre-programmed alerts notified the clinician when growth or size required review. The primary outcome measure was a composite perinatal morbidity/mortality outcome. Results 3993 women were recruited; 45.4% nulliparous; 50.0% Caucasian, 17.8% Asian; 34.9% were overweight/obese prior to pregnancy; average 30 (SD 5.5) years old. The median (IQR) number of growth alerts was 2 (0-3) for both groups (p = 0.378); there was no difference in the total number of ultrasounds per pregnancy (median [IQR] 3 [2-4] for both groups, p = 0.266). There was no significant difference in primary composite outcome (CC 6.4%, SC 7.5%, p = 0.171) or individual components, apart from stillbirth (CC n = 1 0.05%, SC n = 8 0.4%, p = 0.039). Conclusions Use of a CC resulted in no difference in primary outcome, number of growth alerts or number of ultrasounds. Key messages In a large, pragmatic RCT use of a CC in conjunction with serial SFH measurements may infer some benefit over a SC, particularly in relation to stillbirth.

scholarly journals Effectiveness of a volunteer befriending programme for patients with schizophrenia: randomised controlled trial

2019 ◽  
Vol 217 (3) ◽  
pp. 477-483 ◽  
Author(s):  
Stefan Priebe ◽  
Agnes Chevalier ◽  
Thomas Hamborg ◽  
Eoin Golden ◽  
Michael King ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Social Isolation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Social Contacts ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundBefriending by volunteers has the potential to reduce the frequent social isolation of patients with schizophrenia and thus improve health outcomes. However, trial-based evidence for its effectiveness is limited.AimsTo conduct a randomised controlled trial of befriending for patients with schizophrenia or related disorders.MethodPatients were randomised to a befriending programme for 1 year or to receive information about social activities only (trial registration: ISRCTN14021839). Outcomes were assessed masked to allocation at the end of the programme; at 12 months and at a 6-month follow-up. The primary outcome was daily time spent in activities (using the Time Use Survey (TUS)) with intention-to-treat analysis.ResultsA total of 124 patients were randomised (63 intervention, 61 active control) and 92 (74%) were followed up at 1 year. In the intervention group, 49 (78%) met a volunteer at least once and 31 (49%) had more than 12 meetings. At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI −40.7 to 58.5, P = 0.72). There were no significant differences in quality of life, symptoms or self-esteem. However, patients in the intervention group had significantly more social contacts than those in the control group at the end of the 12-month period. This difference held true at the follow-up 6 months later.ConclusionsAlthough no difference was found on the primary outcome, the findings suggest that befriending may have a lasting effect on increasing social contacts. It may be used more widely to reduce the social isolation of patients with schizophrenia.

Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial

2019 ◽  
Vol 46 (2) ◽  
pp. 126-131
Author(s):  
Tashima Lambert ◽  
Tracy Truong ◽  
Beverly Gray
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Pain Perception ◽  
Controlled Trial ◽  
Intrauterine Device ◽  
Provider Satisfaction ◽  
Pain Scores ◽  
Significant Difference ◽  
Method Of Placement ◽  
Randomised Controlled

Introduction'Slow’ and ‘cough’ techniques for tenaculum placement are commonly used. This trial sought to determine if one method of placement resulted in less pain for patients.MethodsThis study was a randomised controlled trial of patients presenting for intrauterine device placement. Sixty-six participants were randomised to tenaculum placement via the 'slow' method (closure of tenaculum over a 5-s period) versus the 'cough' method (closure of tenaculum at the time of patient’s cough). The primary outcome was pain at time of tenaculum placement measured on a 100 mm visual analogue scale. The study was powered to detect a 16 mm difference in pain. Secondary outcomes included pain with insertion and provider satisfaction with tenaculum grasp. Pain scores were analysed with Wilcoxon rank-sum test.ResultsSixty-six women were enrolled, 33 randomised to each group. Demographics were similar in each group. The primary outcome of pain with tenaculum placement showed a median pain score of 44 (IQR=21, 63) with slow placement and 32 (IQR=19, 54) with cough placement. There was no significant difference in pain scores between methods of tenaculum placement (p=0.16). There was no significant difference in overall pain scores (p=0.12). Provider satisfaction was not associated with one method of placement (p=1). Pre-procedure anxiety was significantly associated with pain at the time of tenaculum placement (p=0.01).ConclusionsNeither the slow method nor cough method is superior for pain reduction or provider satisfaction. Pain with tenaculum use is significantly associated with anxiety.Clinical trial registrationNCT02969421.

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