Dataset Information

Pharmacological and Combined Interventions to Reduce Vaccine Injection Pain in Children and Adults: Systematic Review and Meta-Analysis.

ABSTRACT:

Background

This systematic review assessed the effectiveness and safety of pharmacotherapy and combined interventions for reducing vaccine injection pain in individuals across the lifespan.

Design/methods

Electronic databases were searched for relevant randomized and quasi-randomized controlled trials. Self-reported pain and fear as well as observer-rated distress were critically important outcomes. Data were combined using standardized mean difference (SMD) or relative risk with 95% confidence intervals (CI).

Results

Fifty-five studies that examined breastfeeding (which combines sweet-tasting solution, holding, and sucking), topical anesthetics, sweet-tasting solutions (sucrose, glucose), vapocoolants, oral analgesics, and combination of 2 versus 1 intervention were included. The following results report findings of analyses of critical outcomes with the largest number of participants. Compared with control, acute distress was lower for infants breastfed: (1) during vaccination (n=792): SMD -1.78 (CI, -2.35, -1.22) and (2) before vaccination (n=100): SMD -1.43 (CI, -2.14, -0.72). Compared with control/placebo, topical anesthetics showed benefit on acute distress in children (n=1424): SMD -0.91 (CI, -1.36, -0.47) and self-reported pain in adults (n=60): SMD -0.85 (CI, -1.38, -0.32). Acute and recovery distress was lower for children who received sucrose (n=2071): SMD -0.76 (CI, -1.19, -0.34) or glucose (n=818): SMD -0.69 (CI, -1.03, -0.35) compared with placebo/no treatment. Vapocoolants reduced acute pain in adults [(n=185), SMD -0.78 (CI, -1.08, -0.48)] but not children. Evidence from other needle procedures showed no benefit of acetaminophen or ibuprofen. The administration of topical anesthetics before and breastfeeding during vaccine injections showed mixed results when compared with topical anesthetics alone. There were no additive benefits of combining glucose and non-nutritive sucking (pacifier) compared with glucose or non-nutritive sucking (pacifier) alone or breastfeeding and sucrose compared with breastfeeding or sucrose alone.

Conclusions

Breastfeeding, topical anesthetics, sweet-tasting solutions, and combination of topical anesthetics and breastfeeding demonstrated evidence of benefit for reducing vaccine injection pain in infants and children. In adults, limited data demonstrate some benefit of topical anesthetics and vapocoolants.

SUBMITTER: Shah V

PROVIDER: S-EPMC4900424 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Publications

Pharmacological and Combined Interventions to Reduce Vaccine Injection Pain in Children and Adults: Systematic Review and Meta-Analysis.

Shah Vibhuti V Taddio Anna A McMurtry C Meghan CM Halperin Scott A SA Noel Melanie M Pillai Riddell Rebecca R Chambers Christine T CT

The Clinical journal of pain 20151001 10 Suppl

<h4>Background</h4>This systematic review assessed the effectiveness and safety of pharmacotherapy and combined interventions for reducing vaccine injection pain in individuals across the lifespan.<h4>Design/methods</h4>Electronic databases were searched for relevant randomized and quasi-randomized controlled trials. Self-reported pain and fear as well as observer-rated distress were critically important outcomes. Data were combined using standardized mean difference (SMD) or relative risk with ...[more]

PMID: 26201016

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Project description:BackgroundFollowing traumatic brain injury (TBI) there is an increased prevalence of depression compared to the general population. It is unknown whether non-pharmacological interventions for depression are effective for people with TBI.ObjectivesTo investigate the effectiveness of non-pharmacological interventions for depression in adults and children with TBI at reducing the diagnosis and severity of symptoms of depression.Search methodsWe ran the most recent search on 11 February 2015. We searched the Cochrane Injuries Group Specialised Register, The Cochrane Library, MEDLINE (OvidSP), Embase (OvidSP), three other databases and clinical trials registers. Relevant conference proceedings and journals were handsearched, as were the reference lists of identified studies.Selection criteriaRandomised controlled trials (RCTs) of non-pharmacological interventions for depression in adults and children who had a TBI.Data collection and analysisTwo authors independently selected trials from the search results, then assessed risk of bias and extracted data from the included trials. The authors contacted trial investigators to obtain missing information. We rated the overall quality of the evidence of the primary outcomes using the GRADE approach.Main resultsSix studies met the inclusion criteria, with a total of 334 adult participants. We identified no studies that included children as participants. All studies were affected by high risk of bias due to a lack of blinding of participants and personnel; five studies were affected by high risk of bias for lack of blinding of outcome assessors. There was high or unclear risk of biases affecting some studies across all the Cochrane risk of bias measures.Three studies compared a psychological intervention (either cognitive behaviour therapy or mindfulness-based cognitive therapy) with a control intervention. Data regarding depression symptom outcome measures were combined in a meta-analysis, but did not find an effect in favour of treatment (SMD -0.14; 95% CI -0.47 to 0.19; Z = 0.83; P = 0.41). The other comparisons comprised of single studies of depression symptoms and compared; cognitive behaviour therapy versus supportive psychotherapy (SMD -0.09; 95% CI -0.65 to 0.48; Z = 0.30; P = 0.77); repetitive transcranial magnetic stimulation plus tricyclic antidepressant (rTMS + TCA) versus tricyclic antidepressant alone (SMD -0.84; 95% CI -1.36 to -0.32; Z = 3;19, P = 0.001); and a supervised exercise program versus exercise as usual (SMD -0.43; 95% CI -0.88 to 0.03; Z = 1.84; P = 0.07). There was very-low quality evidence, small effect sizes and wide variability of results, suggesting that no comparisons showed a reliable effect for any intervention.Only one study mentioned minor, transient adverse events from repetitive transcranial magnetic stimulation.Authors' conclusionsThe review did not find compelling evidence in favour of any intervention. Future studies should focus on participants with a diagnosed TBI and include only participants who have a diagnosis of depression, or who record scores above a clinical cutoff on a depression measure. There is a need for additional RCTs that include a comparison between an intervention and a control that replicates the effect of the attention given to participants during an active treatment.

Project description:BackgroundSelf-harm (SH; intentional self-poisoning or self-injury) is common, often repeated, and strongly associated with suicide. This is an update of a broader Cochrane review on psychosocial and pharmacological treatments for deliberate SH, first published in 1998 and previously updated in 1999. We have now divided the review into three separate reviews. This review is focused on pharmacological interventions in adults who self harm.ObjectivesTo identify all randomised controlled trials of pharmacological agents or natural products for SH in adults, and to conduct meta-analyses (where possible) to compare the effects of specific treatments with comparison types of treatment (e.g., placebo/alternative pharmacological treatment) for SH patients.Search methodsFor this update the Cochrane Depression, Anxiety and Neurosis Review Group (CCDAN) Trials Search Co-ordinator searched the CCDAN Specialised Register (September 2014). Additional searches of MEDLINE, EMBASE, PsycINFO, and CENTRAL were conducted to October 2013.Selection criteriaWe included randomised controlled trials comparing pharmacological treatments or natural products with placebo/alternative pharmacological treatment in individuals with a recent (within six months) episode of SH resulting in presentation to clinical services.Data collection and analysisWe independently selected trials, extracted data, and appraised trial quality. For binary outcomes, we calculated odds ratios (ORs) and their 95% confidence intervals (CIs). For continuous outcomes we calculated the mean difference (MD) and 95% CI. Meta-analysis was only possible for one intervention (i.e. newer generation antidepressants) on repetition of SH at last follow-up. For this analysis, we pooled data using a random-effects model. The overall quality of evidence for the primary outcome was appraised for each intervention using the GRADE approach.Main resultsWe included seven trials with a total of 546 patients. The largest trial included 167 participants. We found no significant treatment effect on repetition of SH for newer generation antidepressants (n = 243; k = 3; OR 0.76, 95% CI 0.42 to 1.36; GRADE: low quality of evidence), low-dose fluphenazine (n = 53; k = 1; OR 1.51, 95% CI 0.50 to 4.58; GRADE: very low quality of evidence), mood stabilisers (n = 167; k = 1; OR 0.99, 95% CI 0.33 to 2.95; GRADE: low quality of evidence), or natural products (n = 49; k = 1; OR 1.33, 95% CI 0.38 to 4.62; GRADE: low quality of evidence). A significant reduction in SH repetition was found in a single trial of the antipsychotic flupenthixol (n = 30; k = 1; OR 0.09, 95% CI 0.02 to 0.50), although the quality of evidence for this trial, according to the GRADE criteria, was very low. No data on adverse effects, other than the planned outcomes relating to suicidal behaviour, were reported.Authors' conclusionsGiven the low or very low quality of the available evidence, and the small number of trials identified, it is not possible to make firm conclusions regarding pharmacological interventions in SH patients. More and larger trials of pharmacotherapy are required. In view of an indication of positive benefit for flupenthixol in an early small trial of low quality, these might include evaluation of newer atypical antipsychotics. Further work should include evaluation of adverse effects of pharmacological agents. Other research could include evaluation of combined pharmacotherapy and psychological treatment.

Project description:BackgroundSelf-harm (SH; intentional self-poisoning or self-injury regardless of degree of suicidal intent or other types of motivation) is a growing problem in most countries, often repeated, and associated with suicide. Evidence assessing the effectiveness of pharmacological agents and/or natural products in the treatment of SH is lacking, especially when compared with the evidence for psychosocial interventions. This review therefore updates a previous Cochrane Review (last published in 2015) on the role of pharmacological interventions for SH in adults.ObjectivesTo assess the effects of pharmacological agents or natural products for SH compared to comparison types of treatment (e.g. placebo or alternative pharmacological treatment) for adults (aged 18 years or older) who engage in SH.Search methodsWe searched the Cochrane Common Mental Disorders Specialised Register, the Cochrane Library (Central Register of Controlled Trials [CENTRAL] and Cochrane Database of Systematic Reviews [CDSR]), together with MEDLINE. Ovid Embase and PsycINFO (to 4 July 2020).Selection criteriaWe included all randomised controlled trials (RCTs) comparing pharmacological agents or natural products with placebo/alternative pharmacological treatment in individuals with a recent (within six months of trial entry) episode of SH resulting in presentation to hospital or clinical services. The primary outcome was the occurrence of a repeated episode of SH over a maximum follow-up period of two years. Secondary outcomes included treatment acceptability, treatment adherence, depression, hopelessness, general functioning, social functioning, suicidal ideation, and suicide.Data collection and analysisWe independently selected trials, extracted data, and appraised trial quality. For binary outcomes, we calculated odds ratios (ORs) and their 95% confidence internals (CIs). For continuous outcomes we calculated the mean difference (MD) or standardised mean difference (SMD) and 95% CI. The overall certainty of evidence for the primary outcome (i.e. repetition of SH at post-intervention) was appraised for each intervention using the GRADE approach.Main resultsWe included data from seven trials with a total of 574 participants. Participants in these trials were predominately female (63.5%) with a mean age of 35.3 years (standard deviation (SD) 3.1 years). It is uncertain if newer generation antidepressants reduce repetition of SH compared to placebo (OR 0.59, 95% CI 0.29 to 1.19; N = 129; k = 2; very low-certainty evidence). There may be a lower rate of SH repetition for antipsychotics (21%) as compared to placebo (75%) (OR 0.09, 95% CI 0.02 to 0.50; N = 30; k = 1; low-certainty evidence). However, there was no evidence of a difference between antipsychotics compared to another comparator drug/dose for repetition of SH (OR 1.51, 95% CI 0.50 to 4.58; N = 53; k = 1; low-certainty evidence). There was also no evidence of a difference for mood stabilisers compared to placebo for repetition of SH (OR 0.99, 95% CI 0.33 to 2.95; N = 167; k = 1; very low-certainty evidence), or for natural products compared to placebo for repetition of SH (OR 1.33, 95% CI 0.38 to 4.62; N = 49; k = 1; lo- certainty) evidence.Authors' conclusionsGiven the low or very low quality of the available evidence, and the small number of trials identified, there is only uncertain evidence regarding pharmacological interventions in patients who engage in SH. More and larger trials of pharmacotherapy are required, preferably using newer agents. These might include evaluation of newer atypical antipsychotics. Further work should also include evaluation of adverse effects of pharmacological agents. Other research could include evaluation of combined pharmacotherapy and psychological treatment.

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Dataset Information

Pharmacological and Combined Interventions to Reduce Vaccine Injection Pain in Children and Adults: Systematic Review and Meta-Analysis.

Background

Design/methods

Results

Conclusions

Publications

Pharmacological and Combined Interventions to Reduce Vaccine Injection Pain in Children and Adults: Systematic Review and Meta-Analysis.

Similar Datasets

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