Dataset Information

Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial.

ABSTRACT:

Background

The ''gate control" theory suggests pain can be reduced by simultaneous activation of larger diameter nerve fibers using appropriate coldness, warmth, rubbing, pressure, or vibration. This study investigated the efficacy of a device combining cold and vibration, for needle-related procedural pain in children. Methodology. A total of 51 children aged 5-12 years participated in this randomized controlled clinical trial. Half of the children were in the control group and received maxillary buccal infiltration, by injecting 1.8?ml of 2% lidocaine with 1?:?100,000 adrenaline using topical anesthesia 20% benzocaine gel for 15 seconds, while the other half were in the test group and received the same anesthesia using a commercially available external cold and a vibrating device. A face version of Visual Analogue Scale (VAS) was used as a subjective measure to assess the child's pain experience. The parents were requested to evaluate the child's ability to tolerate pain using a behavioral/observational pain scale. Sound, Eyes, and Motor (SEM) scale and Faces, Legs, Activity, Cry, and Consolability (FLACC) scale were used to record the child's pain as perceived by the external evaluator. T-test or Mann-Whitney U-test was used for scale variables, paired sample T-test or Wilcoxon rank t-test was used for before and after data, and chi-square was used for categorical variable, based on the results of normality test.

Results

The results showed a statistically significant reduction in pain after the injection for the test group compared with control using VAS scale (mean?=?6.68 (1.09) and 8.42 (0.50); p=0.001) and FLACC scale (mean?=?5.92 (1.05) and 8.16 (0.54); p=0.002), but not when using SEM scale (mean 3.22 (0.42) and 4.24 (2.74);p=0.08).

Conclusions

Combined external cold and vibrating devices can be an effective alternative in reducing experienced pain and fear in children undergoing infiltration dental anesthesia. This study was registered with clinical trial registry of the United States National Institutes of Health (NIH) at ClinicalTrials.gov (NCT03953001).

SUBMITTER: AlHareky M

PROVIDER: S-EPMC7867453 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial.

AlHareky Muhanad M AlHumaid Jehan J Bedi Sumit S El Tantawi Maha M AlGahtani Mazin M AlYousef Yousef Y

International journal of dentistry 20210130

<h4>Background</h4>The ''gate control" theory suggests pain can be reduced by simultaneous activation of larger diameter nerve fibers using appropriate coldness, warmth, rubbing, pressure, or vibration. This study investigated the efficacy of a device combining cold and vibration, for needle-related procedural pain in children. <i>Methodology</i>. A total of 51 children aged 5-12 years participated in this randomized controlled clinical trial. Half of the children were in the control group and r ...[more]

PMID: 33564311

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Project description:ObjectivePrevious studies suggested that slow injection of propofol may increase the hypnotic effect during induction of anesthesia. The aim of the present study was therefore to investigate whether injection rate of propofol has an influence on its maximum effect.DesignRandomized, single-blind trial.SettingThis study has been carried out in the operating rooms of a university hospital. An anesthesiologist and a resident performed the study with the aid of changing nursing staff.ParticipantsWe investigated 99 unpremedicated patients aged 18 to 60 years with American Society of Anesthesiologists (ASA) physical status 1-3.InterventionsAnesthesia was induced by intravenous injection of propofol (2 mg/kg). Propofol was manually injected in group 1 over a period of 5 s; in group 2 (120-s injection interval), and in group 3 (240-s injection interval), propofol was administered by an injection pump. After loss of consciousness, mask ventilation was performed with 100% oxygen. Bispectral index (BIS) was used to measure the hypnotic effect of propofol. After the decrease of BIS to the minimum value (i.e., maximum hypnotic effect) and the following increase of BIS to 60, the study period was finished and anesthesia was performed according to clinical criteria.Outcome measuresWe analyzed whether injection speed has an influence on the maximum hypnotic effect of a given dose of propofol (2 mg/kg).ResultsBIS(min) marks the maximum electroencephalogram (EEG) effect of the propofol bolus as measured by the BIS. The lowest mean BIS(min) was measured in group 1 (28.7 +/- 10.3). In group 2, BIS(min) was 33.0 (+/-13.9), and in group 3, BIS(min) was 36.4 (+/-11.0). There were no significant differences between group 2 and groups 1 or 3, but there were significant differences between groups 1 and 3. In group 1, BIS(min) was reached after 102.91 s (+/-44.20), in group 2 after 172.33 s (+/-29.76), and in group 3 after 274.21 s (+/-45.40). These differences were statistically significant for all comparisons. In summary, the lowest value for BIS(min) was achieved in the group with the fastest rate of propofol injection (group1, 5 s). The highest BIS(min) was obtained in the group with the slowest rate of injection (group 3, 240 s). The hemodynamic parameters were not significantly different among groups.ConclusionsThe hypnotic peak effect of propofol is lower with extremely slow injection (240 s versus 5 s). For clinically usual injection rates (5 s and 120 s), there was no significant difference in propofol peak effect.

Project description:ImportanceTimely analgesia is critical for children with injuries presenting to the emergency department, yet pain control efforts are often inadequate. Intranasal administration of pain medications provides rapid analgesia with minimal discomfort. Opioids are historically used for significant pain from traumatic injuries but have concerning adverse effects. Intranasal ketamine may provide an effective alternative.ObjectiveTo determine whether intranasal ketamine is noninferior to intranasal fentanyl for pain reduction in children presenting with acute extremity injuries.Design, setting, and participantsThe Pain Reduction With Intranasal Medications for Extremity Injuries (PRIME) trial was a double-blind, randomized, active-control, noninferiority trial in a pediatric, tertiary, level 1 trauma center. Participants were children aged 8 to 17 years presenting to the emergency department with moderate to severe pain due to traumatic limb injuries between March 2016 and February 2017. Analyses were intention to treat and began in May 2017.InterventionsIntranasal ketamine (1.5 mg/kg) or intranasal fentanyl (2 µg/kg).Main outcomes and measuresThe primary outcome was reduction in visual analog scale pain score 30 minutes after intervention. The noninferiority margin for this outcome was 10.ResultsOf 90 children enrolled, 45 (50%) were allocated to ketamine (mean [SD] age, 11.8 [2.6] years; 26 boys [59%]) and 45 (50%) to fentanyl (mean [SD] age, 12.2 [2.3] years; 31 boys [74%]). Thirty minutes after medication, the mean visual analog scale reduction was 30.6 mm (95% CI, 25.4-35.8) for ketamine and 31.9 mm (95% CI, 26.6-37.2) for fentanyl. Ketamine was noninferior to fentanyl for pain reduction based on a 1-sided test of group difference less than the noninferiority margin, as the CIs crossed 0 but did not cross the prespecified noninferiority margin (difference in mean pain reduction between groups, 1.3; 90% CI, -6.2 to 8.7). The risk of adverse events was higher in the ketamine group (relative risk, 2.5; 95% CI, 1.5-4.0), but all events were minor and transient. Rescue analgesia was similar between groups (relative risk, 0.89; 95% CI, 0.5-1.6).Conclusions and relevanceKetamine provides effective analgesia that is noninferior to fentanyl, although participants who received ketamine had an increase in adverse events that were minor and transient. Intranasal ketamine may be an appropriate alternative to intranasal fentanyl for pain associated with acute extremity injuries. Ketamine should be considered for pediatric pain management in the emergency setting, especially when opioids are associated with increased risk.Trial registrationClinicalTrials.gov Identifier: NCT02778880.

Project description:BackgroundDental phobia (DP) and injection phobia (IP) are common in children and adolescents and are considered some of the biggest obstacles to successful treatment in pediatric dentistry. Cognitive behavioral therapy (CBT) is an evidence-based treatment for anxiety and phobias. As the availability of CBT in dentistry is low, internet-based CBT (ICBT) was developed. Open trials have shown that ICBT is a promising intervention, but randomized trials are lacking.ObjectiveThis randomized controlled trial tests whether therapist-guided ICBT supported by a parent could reduce fear, allowing children and adolescents with DP or IP to receive dental treatment.MethodsWe enrolled 33 participants (mean age 11.2, SD 1.9 y) whom a clinical psychologist had diagnosed with DP, IP, or both. After inclusion, participants were randomized to either ICBT (17/33, 52%) or a control group of children on a waitlist (16/33, 48%). ICBT was based on exposure therapy and comprised a 12-week at-home program combined with visits to their regular dental clinic. Participants corresponded weekly with their therapist after completing each module, and 1 parent was designated as a coach to support the child in the assignments during treatment. All participants completed measurements of the outcome variables before treatment start and after 12 weeks (at treatment completion). The measurements included a structured diagnostic interview with a clinical psychologist. Our primary outcome measure was the Picture-Guided Behavioral Avoidance Test (PG-BAT), which assesses the ability to approach 17 dental clinical procedures, and a positive clinical diagnosis. Secondary outcome measures included self-report questionnaires that measured self-efficacy and levels of dental and injection anxiety. The children and their parents completed the questionnaires.ResultsAll participants underwent the 12-week follow-up. After treatment, 41% (7/17) of the participants in the ICBT group no longer met the diagnostic criteria for DP or IP, whereas all participants in the control group did (P=.004). Repeated-measure ANOVAs showed that ICBT led to greater improvements on the PG-BAT compared with the control group; between-group effect sizes for the Cohen d were 1.6 (P<.001) for the child-rated PG-BAT and 1.0 (P=.009) for the parent-rated PG-BAT. Reductions in our secondary outcomes-dental fear and anxiety (P<.001), negative cognitions (P=.001), and injection fear (P=.011)-as well as improvements in self-efficacy (P<.001), were all significantly greater among children in the ICBT group than in the controls. No participants reported adverse events.ConclusionsICBT seems to be an effective treatment for DP and IP in children and adolescents. It reduced fear and anxiety and enabled participants to willingly receive dental treatment. ICBT should be seriously considered in clinical practice to increase accessibility; this therapy may reduce the need for sedation and restraint and lead to better dental health in children and adolescents.Trial registrationClinicalTrials.gov NCT02588079; https://clinicaltrials.gov/study/NCT02588079.

Project description:A few modes of perioperative local analgesia have been studied in order to reduce postoperative pain after laparoscopy, including preemptive local anesthetics in the trocar sites and intraperitoneal anesthetics administration at the end of the surgery. However, the evidence regarding their efficacy are conflicting. In addition, the combination of both aforementioned methods has been rarely studied. Our aim was to evaluate whether subcutaneous trocar site and/or intraperitoneal analgesia reduce pain after gynecologic operative laparoscopy. This was a single-centered, randomized, controlled, double-blinded trial. The patients were randomly assigned to one of four equally sized groups: group 1-subcutaneous and intraperitoneal analgesia; group 2-subcutaneous analgesia and intraperitoneal placebo; group 3-subcutaneous placebo and intraperitoneal analgesia; Group 4-subcutaneous and intraperitoneal placebo. The patients, the surgeons, and the pain evaluators were all blinded to the patient's allocation. Included were patients who underwent elective operative laparoscopy. Exclusion criteria were: active infection, pregnancy, known sensitivity to Bupivacaine-Hydrochloride, chronic pelvic pain, surgeries with additional vaginal procedures, conversion to laparotomy, and malignancy. A total of 9 ml of Bupivacaine-Hydrochloride (Marcaine) 0.5%, or Sodium-Chloride 0.9%, as a placebo, were injected subcutaneously to the trocar sites (3 ml to each trocar site), prior to skin incision. In addition, 10 ml of Bupivacaine-Hydrochloride 0.5%, diluted with 40 ml of Sodium-Chloride 0.9% (a total of 50 ml solution), or 50 ml of Sodium-Chloride 0.9%, as a placebo, were injected intraperitoneally at the end of the surgery. By utilizing the 10 cm Visual-analogue-scale (VAS) we assessed post-operative pain at rest at 3, 8, and 24 h, and during ambulation at 8 and 24 h. The study was approved by the local Institutional Review Board and has been registered at clinicaltrials.gov. We conformed to the CONSORT recommendations. Between December 2016 and July 2019, a total of 119 patients were included in the study. Demographic and interventional characteristics were similar among the groups. The level of postoperative pain, either at rest or with change of position, was not significantly different between the groups, at all-time points. Application of subcutaneous and/or intraperitoneal analgesia is not effective in reducing pain after gynecologic operative laparoscopy.Clinical trial identification number: NCT02976571. Date of trial registration 11/29/2016. URL of the registration site: https://clinicaltrials.gov .

Dataset Information

Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial.

Background

Results

Conclusions

Publications

Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial.

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