scholarly journals Efficacy of Oral Glucose in Reducing Behavioural Responses to a Noxious Stimulus in Healthy Term Neonates

2021 ◽  
Author(s):  
Amal Naous ◽  
Hassan El Khatib ◽  
Bilal Azakir ◽  
Farah Hajjar ◽  
Hanan Baltaji ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Pain Scale ◽  
Full Term ◽  
Oral Glucose ◽  
Pain Response ◽  
Double Blind ◽  
Term Neonates ◽  
Neonatal Pain ◽  
Infant Pain ◽  
Heel Prick

Abstract The aim of the study is to evaluate the effect of orally administered glucose, at concentrations of 5% and 30%, on the nociceptive behavioural pain response among full-term neonates who underwent the heel puncture technique. This is a prospective, randomized, double-blind, placebo-controlled trial which was registered at clinicaltrials.gov under the number Makassed General Hospital Protocol Record 1722017 in July 2017. This trial studied the effect of glucose solution on pain relief in 244 full-term healthy neonates who underwent a heel prick procedure. Neonatal pain was assessed using the Neonatal Infant Pain Scale (NIPS) and the duration of cry. The results showed that neonates receiving 30% glucose during the procedure had significantly the lowest mean NIPS (mean=4.89) compared to placebo and 5% group (mean=5.8 and 5.2 respectively) (p=0.03). Neonates in the glucose groups of both 5% (65.9%) and 30% (70.4%) scored significantly as having less pain compared with the placebo group (86.4%) (p=0.01). The neonates in the 30% glucose group cried less and had a significantly shorter crying duration (mean: 39.9 seconds) than in the 5% and placebo groups (p=0.04). Conclusion: 30% glucose and, to a lesser extent, 5% glucose were effective in reducing the behavioral pain response from heel prick procedures in term neonates.

scholarly journals Baseline Characteristics of Participants in a Randomized Controlled Trial of Metformin for Frailty Prevention

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 130-131
Author(s):  
Tiffany Cortes ◽  
Nicolas Musi ◽  
Chen-pin Wang ◽  
Joel Michalek ◽  
Sara Espinoza
Keyword(s):  
Randomized Controlled Trial ◽  
Glucose Tolerance ◽  
Physical Performance ◽  
Controlled Trial ◽  
Tolerance Test ◽  
Oral Glucose ◽  
Double Blind ◽  
Randomized Controlled ◽  
Insulin Clamp ◽  
And Function

Abstract We are conducting a double-blind, randomized controlled trial of metformin for frailty prevention. Participants are adults aged 65+ years with pre-diabetes assessed by 2-hour oral glucose tolerance test (OGTT). Those who are frail (Fried criteria) are excluded. Participants are randomized to metformin (maximum dose of 2,000 mg/day) vs. placebo and followed for 2 years. The primary outcome is frailty (category and score); secondary outcomes are physical performance and function (short physical performance battery, 6-minute walk, lower extremity strength), systemic and skeletal muscle tissue inflammation, muscle insulin signaling, insulin sensitivity (insulin clamp), glucose tolerance (OGTT), and body composition (dual-energy x-ray absorptiometry). Safety assessments occur every 3 months; frailty, systemic inflammation, and OGTT are assessed at baseline and every 6 months, and insulin clamp with muscle biopsies are assessed at baseline and every 12 months. To date, 85 subjects have been randomized; 120 completers are planned. Mean age is 72.8 ± 5.7 years, 55.3% are male, and 43.5% were Hispanic. Mean BMI is 30.2±5.8 kg/m2, waist circumference is 104.4 ±15.5 cm, fasting glucose is 102.3 ± 10.0 mg/dL, Hemoglobin A1c is 5.8 ±0.3, and glucose at 2 hours during OGTT is 167.3 ± 17.8 mg/dL. Metformin is being examined in this study as a potential therapeutic agent to prevent frailty in older adults with pre-diabetes. Findings from this trial may have future implications for the screening and potential treatment of pre-diabetes in older patients with metformin for the prevention of frailty.

scholarly journals Analgesia in newborns: a case-control study of the efficacy of nutritive and non-nutritive sucking stimuli

CoDAS ◽  
2013 ◽  
Vol 25 (4) ◽  
pp. 365-368 ◽  
Author(s):  
Ana Henriques Lima ◽  
Ana Paula Hermont ◽  
Amélia Augusta de Lima Friche
Keyword(s):  
Case Control Study ◽  
Pain Scale ◽  
Case Control ◽  
Control Group ◽  
Pain Response ◽  
The Third ◽  
Nutritive Sucking ◽  
Lower Pain ◽  
Infant Pain ◽  
Control Study

PURPOSE: To verify the nutritive and non-nutritive stimuli efficacy in the newborn's response to pain during venipuncture. METHODS: The main sample was composed of 64 newborns that were randomly divided into three groups. The first group (n=20) received nutritive sucking stimulus that was performed through maternal breastfeeding. The second group (n=21) received non-nutritive sucking stimulus that was performed through the introduction of the researcher little finger in the newborn's oral cavity. The third group or control group (n=23) did not receive any analgesia stimulus. The newborns were evaluated using the Neonatal Infant Pain Scale, and the responses to painful stimuli were compared. RESULTS: The nutritive as well as non-nutritive suction methods provided a comforting effect, resulting in lower pain response scores (p<0.05). There was no difference between the analgesia provided by both methods (p>0.05). CONCLUSION: The nutritive and the non-nutritive sucking stimuli proved to be efficacious tools in relieving pain among newborns.

scholarly journals Music for pain in healthy neonates

2021 ◽  
Vol 61 (2) ◽  
pp. 69-73
Author(s):  
Nessie Amelia Ramli ◽  
Afifa Ramadanti ◽  
Indrayady Indrayady ◽  
Yuli Doris Memy
Keyword(s):  
Heart Rate ◽  
Pain Perception ◽  
Periventricular Leukomalacia ◽  
Pain Scale ◽  
Injection Pain ◽  
Medical Procedure ◽  
Music Intervention ◽  
Older Children ◽  
Double Blind ◽  
Infant Pain

Background The neonatal pain threshold is 30-50% lower than in adults and older children because of immature pain inhibition function in nervous centers. Acute pain in neonates results in behavioral, physiological, and cerebral blood flow changes that may lead to intraventricular bleeding and periventricular leukomalacia. Music is believed to reduce pain perception as it distracts, influencing the parasympathetic and sympathetic nervous system by decreasing pulse rate, blood pressure, and breathing, hence, promoting a relaxed state. Objective To evaluate effects of music intervention on physiological parameters and pain perception in healthy newborns undergoing a painful medical procedure (immunization injection). Methods This was a double-blind, randomized control trial study. A recorded instrumental lullaby “Nina Bobo” was given for 5 minutes to the music group and no music for control, prior injection of Hepatitis B 0. The evaluation of heart rate and SpO2 were performed at baseline, 30 seconds, and 5 minutes after injection. Pain perception were measured by Neonatal Infant Pain Scale (NIPS) at 30 seconds and 5 minutes after injection. Results Total of 51 subjects were enrolled. There were no difference of SpO2 and NIPS between both music and control groups. Music improved heart rate after 30 seconds and 5 minutes after injection,  median 126 (range 55-149) bpm from median 136 (range 78-154) bpm, and even lower than baseline [mean 128.9 (SD 12.5) bpm; P=0.019]. The control showed no improvement of heart rate mean 124,34 (SD 18,45) from 124,73 (SD 18,39); P=0.875There were no significant differences between the 2 groups. Conclusion Music is not effective in improving oxygen saturation, heart rate, and is not effective in reducing the degree of pain.

scholarly journals Effect of antenatal dietary myo-inositol supplementation on the incidence of gestational diabetes mellitus and fetal outcome: protocol for a double-blind randomised controlled trial

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e055314
Author(s):  
Ibrahim Ibrahim ◽  
Hala Abdullahi ◽  
Yassin Fagier ◽  
Osman Ortashi ◽  
Annalisa Terrangera ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Controlled Trial ◽  
Tolerance Test ◽  
Dietary Advice ◽  
Controlled Clinical Trial ◽  
Oral Glucose ◽  
Double Blind ◽  
Registration Number

IntroductionGestational diabetes mellitus (GDM) affects 23.6% of Qatari women and is associated with maternal and perinatal morbidity and long-term risk of developing type 2 diabetes. A number of challenges exist with current interventions, including non-compliance with dietary advice, the reluctance of mothers to ingest metformin tablets or use insulin injections. These challenges highlight the importance of pursuing evidence-based prevention strategies. Myo-inositol is readily available as an US Food and Drug Administration-approved food supplement with emerging but limited evidence suggesting it may be beneficial in reducing the incidence of GDM. Further studies, such as this one, from different ethnic contexts and with differing risk factors, are urgently needed to assess myo-inositol effects on maternal and neonatal outcomes.Methods and analysisThis study is a prospective, randomised, double-blinded, placebo controlled clinical trial to either myo-inositol supplementation or placebo.We plan to enrol 640 pregnant women attending antenatal care at Sidra Medicine, Doha, Qatar, 320 in each arm. All participants will complete at least 12 weeks of supplementation prior to undertaking the Oral Glucose Tolerance Test at 24–28 weeks. The daily use of the trial supplementation will continue until the end of pregnancy. All outcome measures will be collected from the electronic medical records.Ethics and disseminationEthical approval for the study was obtained on 12 April 2021 from Sidra Medicine (IRB number 1538656). Results of the primary trial outcome and secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberProspectively registered on 26 May 2021. Registration number ISRCTN16448440 (ISRCTN registry).

Using feeding to reduce pain during vaccination of formula-fed infants: a randomised controlled trial

2018 ◽  
Vol 103 (12) ◽  
pp. 1132-1137 ◽  
Author(s):  
Netty G P Bos-Veneman ◽  
Marrit Otter ◽  
Sijmen A Reijneveld
Keyword(s):  
Side Effects ◽  
Controlled Trial ◽  
Recovery Phase ◽  
Pain Scale ◽  
Formula Feeding ◽  
Full Term ◽  
Intention To Treat ◽  
Registration Number ◽  
The Face ◽  
Randomised Controlled

ObjectivesTo assess the effectiveness and potential side effects of formula feeding to reduce pain during vaccination among infants.Study designIn the setting of well-baby clinics we recruited a community-based sample of full-term born infants who were already formula fed by the choice of the parents (n=48, aged 4–10 weeks) and received their first DTaP-IPV-HepB-Hib and pneumococcal vaccinations and randomised them into two groups. To evaluate pain experienced during vaccination we compared infants who drank formula feeding before, during and after vaccination with infants who did not. Outcomes were observed cry duration and pain scores measured by means of the Neonatal Infant Pain Scale (NIPS) and the Face, Legs, Activity, Cry and Consolability (FLACC) scale. Side effects of drinking during vaccination were recorded. We performed intention-to-treat analyses using regression models, crude and adjusted for sex and age of the infant.ResultsPain at the moment of the second injection did not differ between groups. Drinking infants cried 33.5 s shorter (−56.6; −10.3). In the first minute after injection drinking infants experienced a faster pain reduction on the NIPSΔt: regression coefficient 3.86 (95% CI 2.70 to 5.02) and FLACCΔt: 4.42 (95% CI 2.85 to 5.99).ConclusionsIn line with findings of previous studies regarding breast feeding, formula feeding reduced vaccination pain in the recovery phase in full-term born infants receiving their first vaccinations between ages 4 and 10 weeks with no adverse effects. Professionals should discuss this non-costly and feasible pain-reducing intervention with parents of infants who receive vaccinations.Trial registration numberIRCTN 31383, post-results

scholarly journals Influence of Cinnamon on Glycemic Control in Individuals With Prediabetes: A Randomized Controlled Trial

2020 ◽  
Vol 4 (11) ◽  
Author(s):  
Giulio R Romeo ◽  
Junhee Lee ◽  
Christopher M Mulla ◽  
Youngmin Noh ◽  
Casey Holden ◽  
...  
Keyword(s):  
Glucose Tolerance ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Cost Effective ◽  
Tolerance Test ◽  
Controlled Clinical Trial ◽  
Oral Glucose ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Favorable Safety

Abstract Context The identification of adjunct safe, durable, and cost-effective approaches to reduce the progression from prediabetes to type 2 diabetes (T2D) is a clinically relevant, unmet goal. It is unknown whether cinnamon’s glucose-lowering properties can be leveraged in individuals with prediabetes. Objective The objective of this work is to investigate the effects of cinnamon on measures of glucose homeostasis in prediabetes. Design, Setting, Participants, and Intervention This double-blind, placebo-controlled, clinical trial randomly assigned adult individuals meeting any criteria for prediabetes to receive cinnamon 500 mg or placebo thrice daily (n = 27/group). Participants were enrolled and followed at 2 academic centers for 12 weeks. Main Outcome Measures Primary outcome was the between-group difference in fasting plasma glucose (FPG) at 12 weeks from baseline. Secondary end points included the change in 2-hour PG of the oral glucose tolerance test (OGTT), and the change in the PG area under the curve (AUC) derived from the OGTT. Results From a similar baseline, FPG rose after 12 weeks with placebo but remained stable with cinnamon, leading to a mean between-group difference of 5 mg/dL (P &lt; .05). When compared to the respective baseline, cinnamon, but not placebo, resulted in a significant decrease of the AUC PG (P &lt; .001) and of the 2-hour PG of the OGTT (P &lt; .05). There were no serious adverse events in either study group. Conclusions In individuals with prediabetes, 12 weeks of cinnamon supplementation improved FPG and glucose tolerance, with a favorable safety profile. Longer and larger studies should address cinnamon’s effects on the rate of progression from prediabetes to T2D.

Combined nitrous oxide 70% with intranasal fentanyl for procedural analgosedation in children: a prospective, randomised, double-blind, placebo-controlled trial

2019 ◽  
Vol 36 (3) ◽  
pp. 142-147 ◽  
Author(s):  
Michelle Seiler ◽  
Georg Staubli ◽  
Markus A. Landolt
Keyword(s):  
Nitrous Oxide ◽  
Adverse Events ◽  
Scale Score ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Pain Scale ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Group ◽  
Registration Number

ObjectiveNitrous oxide 70% (N2O 70%) is an excellent medication for procedural analgosedation (PAS), yet the limit of its analgesic power remains uncertain; therefore, a combination with intranasal fentanyl (INF) was suggested. However, this combination seems to result in a higher rate of vomiting and deeper sedation. This study aimed at assessing the analgesic efficacy, sedation depth and rate of adverse events of PAS with N2O 70% with and without INF.MethodsPatients aged 2–16 years who qualified for PAS with N2O 70% were randomly assigned to receive either INF or placebo prior to N2O inhalation in this randomised, double-blind study, which was performed in a tertiary children’s hospital ED between September 2015 and October 2017. Behaviour during the procedure was evaluated using the Face, Leg, Activity, Cry and Consolability (FLACC) scale and the Modified Behavioural Pain Scale (MBPS); analgesic efficacy was assessed with a self-reported pain scale. Sedation depth using the validated University of Michigan Sedation Scale and adverse events in the ED and during the following 12 hours were documented.ResultsA total of 402 patients were included; 3 did not tolerate N2O and therefore had to be excluded. Overall, 399 patients were analysed, of whom 201 (50.4%) received INF. No significant group differences with regard to FLACC scale score, self-reported pain, MBPS score and sedation depth were found. In addition, the two groups did not differ with regard to all types of adverse events.ConclusionCombining N2O 70% with INF resulted in no differences with regard to FLACC scale score, self-reported pain, MBPS score, patient and parental satisfaction rate, sedation depth, and adverse events.Trial registration numberNCT02533908

scholarly journals Effects of vitamin K2 supplementation on atherogenic status of individuals with type 2 diabetes: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Fatemeh Rahimi Sakak ◽  
Nazanin Moslehi ◽  
Hengameh Abdi ◽  
Parvin Mirmiran
Keyword(s):  
Insulin Resistance ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Resistance Index ◽  
Vitamin K2 ◽  
Atherogenic Index ◽  
Oral Glucose ◽  
Double Blind ◽  
Daily Intakes

Abstract Background This study was aimed to examine the effects of vitamin K2 supplementation on atherogenic status, assessed by insulin resistance (IR)-related indexes, in patients with type 2 diabetes mellitus (T2DM). Methods In this double-blind, controlled trial, 68 patients with T2DM on the oral glucose-lowering medications were randomly allocated into two groups receiving daily intakes of 360 μg MK-7 or placebo for 12 weeks. Eight different IR-related indexes were calculated at the baseline and end of the trial. Results At the end of the study, atherogenic coefficient (mean ± SD: − 0.21 ± 0.45 vs. 0.02 ± 0.43; p = 0.043), triglyceride-glucose index (8.88 ± 0.55 vs. 9.23 ± 0.69; p = 0.029), and atherogenic index of plasma (0.37 ± 0.27 vs. 0.51 ± 0.24; p = 0.031) were significantly lower in the vitamin K2 group, compared to the placebo. However, after accounting for their baseline values, the differences were no more significant. No significant differences were observed in Castelli’s Ӏ and ӀӀ risk indexes, the ratio of triglycerides to high-density lipoprotein cholesterol, lipoprotein combine index, and the metabolic score for insulin resistance index between the two groups at the end of the study. Conclusions Daily intakes of 360 μg vitamin K2 in the form of MK-7 for 12 weeks could not improve the IR-related indexes of Cardiovascular Diseases risk. Trial registration The trial was registered on Iranian Registry of Clinical Trials registry (Trial ID. IRCT20190824044592N1) on 22 December 2019. The record can be found at https://en.irct.ir/trial/41728.

scholarly journals Breastmilk as a Multisensory Intervention for Relieving Pain during Newborn Screening Procedures: A Randomized Control Trial

2021 ◽  
Vol 18 (24) ◽  
pp. 13023
Author(s):  
Hsiang-Yun Lan ◽  
Luke Yang ◽  
Chiao-Hsuan Lin ◽  
Kao-Hsian Hsieh ◽  
Yue-Cune Chang ◽  
...  
Keyword(s):  
Newborn Screening ◽  
Controlled Trial ◽  
Phase 1 ◽  
Routine Care ◽  
Pain Scale ◽  
Baseline Phase ◽  
Video Recordings ◽  
Treatment Conditions ◽  
Relieve Pain ◽  
Infant Pain

The study aim was to explore the effects of multisensory breastmilk interventions on short-term pain of infants during newborn screening. This is a randomized controlled trial. A total of 120 newborns were recruited and assigned by randomization to one of three treatment conditions: Condition 1 = routine care (gentle touch + verbal comfort); Condition 2 = breastmilk odor + routine care; or Condition 3 = breastmilk odor + taste + routine care. Pain was scored with the Neonatal Infant Pain Scale (NIPS). Data were collected from video recordings at 1 min intervals over the 11 phases of heel sticks: phase 1, 5 min before heel stick without stimuli (baseline); phase 2 to phase 6 (during heel stick); and phase 7 to phase 11 (recovery). Generalized estimating equations compared differences in pain scores for newborns over phases among the three conditions. Compared with the routine care, provision of the odor and taste of breastmilk reduce NIPS scores during heel sticks (B = −4.36, SE = 0.45, p < 0.001 [phase6]), and during recovery (B = −3.29, SE = 0.42, p < 0.001 [phase7]). Our findings provide new data, which supports the use of multisensory interventions that include breastmilk odor and taste in combination with gentle touch and verbal comfort to relieve pain in infants undergoing newborn screening.

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