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NCT ID: NCT02638506 Terminated - Headaches Clinical Trials

RCT Evaluating Intranasal Fentanyl in the Pain Management of Children With Headaches

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Background : Headaches are a common presentation for children consulting to the Emergency Department (ED). However, only few studies have evaluated the rapid pain improvement provided by medications in the acute management of headaches in the pediatric population. Objective : To evaluate pain reduction provided by intranasal fentanyl (INF) compared to placebo in addition to ibuprofen for children presenting to a pediatric ED with moderate to severe headaches. Methods : A single-center, double-blind, randomized, placebo controlled clinical trial will be conducted in an urban, university-affiliated, tertiary care pediatric hospital ED. All children eight to 18 years old who will present to the ED with headaches as a main chief complaint and with pain of ≥ 36 mm out of 100 on Visual Analog Scale (VAS) will be recruited. Study participants will be randomly allocated to receive INF 1.5 mcg/kg (maximum dose of 100 mcg) or similar volume of a placebo solution via an atomizer. Co-administration of oral ibuprofen 10 mg/kg (maximum dose of 600 mg) will also be provided to the two groups if not received in the previous 4 hours. The primary outcome will be the mean pain rating reduction at 15 minutes. The secondary outcomes will be mean pain reduction at 30 and 60 minutes, patient's and parental satisfaction levels, percent of being pain free, sedation score, immediate and within 72 hours adverse events, additional ED analgesics and other medications, length of ED stay, disposition outcomes, hospital admission rate and ED revisit rate within 72 hours. The primary analysis will use an intention-to-treat approach to compare mean pain score reduction between the two groups using a Student's T-test. The sample size of 60 participants per arm was calculated to have a power of 80% to identify a difference of 10 mm in the VAS. Expected results : Our study might demonstrate that INF provides additional pain relief for children presenting to an ED with headaches. Providing INF could relieve their symptoms more quickly, potentially improve patient's and family's satisfaction, possibly reduce the length of their ED stay and consequently, have a significant impact on patient quality of care and cost-effectiveness.

NCT ID: NCT02270177 Completed - Headaches Clinical Trials

Telemedicine Versus Traditional Specialist Consultation for Headache: a Non-inferiority Trial

VHS
Start date: September 2012
Phase: N/A
Study type: Interventional

Headache is a frequent cause of visits to the GPs office, and the investigators have previously shown that this group accounts for about 20 % of patients referred to a general neurologic outpatient clinic. To our knowledge, no previous study has investigated whether headache consultation through telemedicine provides equal health care outcomes compared to regular visit to the neurologist. If that's the case, a modern interactive health care system may give simpler and cheaper services for patients, saving travelling costs and community expenses. It may possibly also lead to reduced waiting lists, earlier diagnosis and treatment. This is an open-labeled randomized non-inferiority trial of headache patients referred to a neurologic clinic in North-Norway. The aim of this study is to determine whether video consultations are non-inferior to regular consultations in diagnosing and treating primary headaches. The null hypothesis is that there is no difference in patient satisfaction between the two groups. The outcome is assessed 3 and 12 months after the neurologic consultation. Participants will be allocated to either a telemedicine consultation or a regular consultation at the neurologic outpatient clinic in the University Hospital of North-Norway, Tromsø. Both groups will undergo a structured and detailed interview to clarify the diagnosis and establish appropriate treatment. To ensure the best possible representation in the population, our goal is to include at least 70% of all the referred patients that meet the criteria for participation. The randomizations are made through a centralized 8-16 phone line to the research-department in Tromsø, at the University Hospital of North-Norway. Both primary and secondary endpoints will be assessed in questionnaires sent three and 12 months after the consultation. In addition, the quality of the physicians` referrals and calculations of cost savings by using telemedicine will be evaluated. The patients' informed consent will always be obtained before data collection. Patients are able to withdraw from the study at any time. Withdrawal will not affect the treatment or follow up. Local research ethics committee (REC) has approved the study.

NCT ID: NCT01667679 Completed - Migraine Clinical Trials

Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without

COMPASS
Start date: August 2012
Phase: Phase 3
Study type: Interventional

This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine headaches in 30 minutes after use.

NCT ID: NCT00956969 Completed - Headaches Clinical Trials

Stress Management for Chronic Headaches

Start date: September 2009
Phase: N/A
Study type: Interventional

This interventional, randomized controlled study seeks to test the effects of a novel emotional awareness and expression intervention against relaxation training or no intervention for college students with chronic headaches. These two interventions are conceptually quite distinct, as the former seeks to activate and process anger, whereas the latter, more commonly used technique, seeks to suppress or avoid it.

NCT ID: NCT00921453 Completed - Headaches Clinical Trials

Tailored Internet Information Supply for Patients - Part 2

Start date: April 2009
Phase: N/A
Study type: Observational

Medical expert systems in combination with portal searching meta-search engines are exploited to provide reliable patient-tailored information. A prototype of a web-based information system has been developed and is to be evaluated. Its aim is to answer the decisive question whether expert system guided internet meta-search provides a better information supply for patients seeking health information online then this is possible by using ordinary search engines or health portals. The research does neither investigate the influence of ethical nor legal aspects of internet health information supply.

NCT ID: NCT00484029 Completed - Pain Clinical Trials

Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain

Start date: February 2007
Phase: Phase 2
Study type: Interventional

This purpose of this study is to evaluate the safety and efficacy of treatment with nasal CO2 in the treatment of pain and other symptoms related to temporomandibular disorder (TMD).

NCT ID: NCT00475189 Completed - Pelvic Pain Clinical Trials

Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills)

Start date: June 2007
Phase: N/A
Study type: Interventional

The purpose of this research study is to assess hormone withdrawal symptoms in women while taking an oral contraceptive in the novel 24/4 (24 days of "real" pills) manner in comparison to taking pills in the standard 21/7 (21 "real" pills) manner. It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms compared to the standard 21/7 regimen. It is further hypothesized that women using the 24/4 regimen will report greater satisfaction scores.

NCT ID: NCT00067249 Completed - Depression Clinical Trials

Women's Use of Alternative Medicine: A Multiethnic Study

Start date: April 2001
Phase: N/A
Study type: Observational

The purpose of this study is to examine socio-cultural factors of women’s use of complementary and alternative medicine (CAM). The effects of socioeconomic status, social networks and acculturation on CAM use will be assessed among white, African-, Mexican-, and Chinese-American women.