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The Cochrane Database of Systematic... Jul 2017Extravasation injury, a complication commonly seen in the neonatal intensive care unit, can result in scarring with cosmetic and functional sequelae. A wide variety of... (Review)
Review
BACKGROUND
Extravasation injury, a complication commonly seen in the neonatal intensive care unit, can result in scarring with cosmetic and functional sequelae. A wide variety of treatments are available, including subcutaneous irrigation with saline (with or without hyaluronidase), liposuction, use of specific antidotes, topical applications, and normal wound care with dry or wet dressings. All such treatments aim to prevent or reduce the severity of complications.
OBJECTIVES
Primary objective To compare the efficacy and safety of saline irrigation or saline irrigation with prior hyaluronidase infiltration versus no intervention or normal wound care for tissue healing in neonates with extravasation injury. Secondary objectives To evaluate by subgroup analysis of controlled trials the influence of type of extravasate, timing of irrigation following extravasation, and postmenstrual age (PMA) of the neonate at the time of injury on outcomes and adverse effects.Specifically, we planned to perform subgroup analysis for the primary outcome, if appropriate, by examining:1. time to irrigation from identified extravasation injury (< 1 hour or ≥ 1 hour);2. type of extravasate (parenteral nutrition fluid or other fluids or medications);3. amount of saline used (< 500 mL or ≥ 500 mL); and4. PMA at injury (< 37 completed weeks or ≥ 37 completed weeks).
SEARCH METHODS
We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 1), MEDLINE via PubMed (1966 to 2 February 2017), Embase (1980 to 2 February 2017), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 2 February 2017). We also searched clinical trial databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We used the Google Scholar search tool for reverse citations of relevant articles.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and quasi-randomised controlled trials comparing saline irrigation with or without hyaluronidase infiltration versus no intervention or normal wound care for the management of extravasation injury in neonates.
DATA COLLECTION AND ANALYSIS
Three review authors independently reviewed and identified articles for possible inclusion in this review. We used the GRADE approach to assess the quality of evidence.
MAIN RESULTS
We found no eligible studies. Our search revealed 10 case reports or case series describing successful outcomes with different interventions for this condition.
AUTHORS' CONCLUSIONS
To date, no RCTs have examined the effects of saline irrigation with or without prior hyaluronidase infiltration for management of extravasation injury in neonates. Saline irrigation is frequently reported in the literature as an intervention for management of extravasation injury in neonates. Research should focus first on evaluating the efficacy and safety of this intervention through RCTs. It will also be important for investigators to determine effect size by examining the timing of the intervention, the nature of the infusate, and severity of injury at the time of intervention.
Topics: Extravasation of Diagnostic and Therapeutic Materials; Humans; Hyaluronoglucosaminidase; Infant, Newborn; Medical Records; Skin; Sodium Chloride; Solutions; Therapeutic Irrigation
PubMed: 28724193
DOI: 10.1002/14651858.CD008404.pub3 -
The Cochrane Database of Systematic... Feb 2014Perineal hyaluronidase (HAase) injection was widely used to reduce the occurrence of perineal trauma, pain and need for episiotomy in the 1950s to 1960s. Reports... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Perineal hyaluronidase (HAase) injection was widely used to reduce the occurrence of perineal trauma, pain and need for episiotomy in the 1950s to 1960s. Reports suggested that the administration of HAase was a simple, low risk, low cost and effective way to decrease perineal trauma without adverse effects.
OBJECTIVES
The objective of this review was to assess the effectiveness and safety of perineal HAase injection for reducing spontaneous perineal trauma, episiotomy and perineal pain in vaginal deliveries.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2013), the International Clinical Trials Registry Platform (ICTRP) and the Networked Digital Library of Theses and Dissertations (both on 1 April 2013), and reference lists of retrieved studies. We also contacted relevant organisations.
SELECTION CRITERIA
Published and unpublished randomised and quasi-randomised controlled trials comparing perineal HAase injection with placebo injection or no intervention in vaginal deliveries.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion, extracted data and evaluated methodological quality. Data were checked for accuracy.
MAIN RESULTS
The search strategy identified six potentially eligible studies. Two studies were excluded. We included four randomised controlled trials that randomised a total of 599 women (data were available for 595 women).Two trials (283 women) compared the effects of perineal HAase injection during the second stage of labour with placebo injection and were at low risk of bias. Three trials (one three-armed trial was analysed twice) (373 women) compared the effects of perineal HAase injection during second stage of labour with no intervention and two out of the three trials were at high risk of bias. Data from four trials involving 599 women suggested that perineal HAase injection during second stage of labour had a lower incidence of perineal trauma (average risk ratio (RR) 0.69, 95% confidence interval (CI) 0.50 to 0.95,Tau² = 0.08, I² = 82% compared with women in the control group, but there was no clear evidence of a reduction in the incidence of episiotomy (average RR 0.74, 95% CI 0.43 to 1.29, Tau² = 0.17, I² = 66%), first and second degree perineal lacerations (average RR 0.54, 95% CI 0.38 to 1.33, Tau² = 0.30 , I² = 85%) and third and fourth degree perineal lacerations (RR 0.12, 95% CI 0.01 to 2.13). Data from two trials involving 283 women indicated that there was no clear evidence of a reduction in the incidence of perineal trauma (RR 0.90, 95% CI 0.77 to 1.06, Tau²=1.07, I² = 7%), episiotomy (RR 0.77, 95% CI 0.32 to 1.89, Tau² = 0.27, I² = 54%), first and second degree perineal lacerations (RR 1.08, 95% CI 0.83 to 1.40, Tau² = 1.11, I² = 10%) and third and fourth degree perineal lacerations (RR 0.12, 95% CI 0.01 to 2.13) with perineal HAase injection. Data from three trials involving 373 women suggested that perineal HAase injection during second stage of labour had a lower incidence of perineal trauma (RR 0.61, 95% CI 0.42 to 0.88, Tau² = 0.08, I² = 78%) compared with no intervention, but had no clear effect on in the incidence of episiotomy (RR 0.79, 95% CI 0.44 to 1.42, Tau² = 0.16, I² = 70%) and first and second degree perineal lacerations (RR 0.58, 95% CI 0.31 to 1.10, Tau² = 0.18, I² = 59%). No side effects were reported in the included trials.No included trials reported on perineal pain and other pre-specified secondary outcomes: perineal trauma requiring suturing; blood loss; dyspareunia; urinary incontinence; faecal incontinence; assisted delivery rate; women's satisfaction; Apgar score less than seven at five minutes and need for admission to special care baby unit.
AUTHORS' CONCLUSIONS
Perineal HAase injection during second stage of labour had a lower incidence of perineal trauma compared with control or no intervention, but there was no clear evidence of benefit compared with placebo injection. The difference in incidence of perineal trauma may probably be due to bias and confounding in the non-placebo controlled comparison, this result should be interpreted cautiously. The potential use of perineal HAase injection as a method to reduce perineal trauma were yet to be determined as there was no appropriate established dose for HAase, no evidence of follow up, and the number of high-quality trials and outcomes reported were too limited to draw conclusions on its effectiveness and safety. Further rigorous randomised controlled trials are required to evaluate the role of perineal HAase injection in vaginal deliveries.
Topics: Adult; Delivery, Obstetric; Episiotomy; Female; Humans; Hyaluronoglucosaminidase; Labor Stage, Second; Lacerations; Obstetric Labor Complications; Perineum; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 24497276
DOI: 10.1002/14651858.CD010441.pub2 -
Pain Physician Jan 2007Percutaneous epidural adhesiolysis and spinal endoscopic adhesiolysis are interventional pain management techniques used to treat patients with refractory low back pain... (Review)
Review
BACKGROUND
Percutaneous epidural adhesiolysis and spinal endoscopic adhesiolysis are interventional pain management techniques used to treat patients with refractory low back pain due to epidural scarring. Standard epidural steroid injections are often ineffective, especially in patients with prior back surgery. Adhesions in the epidural space can prevent the flow of medicine to the target area; lysis of these adhesions can improve the delivery of medication to the affected areas, potentially improving the therapeutic efficacy of the injected medications.
STUDY DESIGN
A systematic review utilizing the methodologic quality criteria of the Cochrane Musculoskeletal Review Group for randomized trials and the criteria established by the Agency for Healthcare Research and Quality (AHRQ) for evaluation of randomized and non-randomized trials.
OBJECTIVE
To evaluate and update the effectiveness of percutaneous adhesiolysis and spinal endoscopic adhesiolysis in managing chronic low back and lower extremity pain due to radiculopathy, with or without prior lumbar surgery, since the 2005 systematic review.
METHODS
Basic search identified the relevant literature, in the MEDLINE, EMBASE, and BioMed databases (November 2004 to September 2006). Manual searches of bibliographies of known primary and review articles, and abstracts from scientific meetings within the last 2 years were reviewed. Randomized and non-randomized studies are included in the review based on criteria established. Percutaneous adhesiolysis and endoscopic adhesiolysis are analyzed separately.
OUTCOME MEASURES
The primary outcome measure was significant pain relief (50% or greater). Other outcome measures were functional improvement, improvement of psychological status, and return to work. Short-term relief was defined as less than 3 months, and long-term relief was defined as 3 months or longer.
RESULTS
Studies regarding the treatment of epidural adhesions for the treatment of low back and lower extremity pain were sought and reviewed. The evidence from the previous systematic review was combined with new studies since November 2004. There is strong evidence for short term and moderate evidence for long term effectiveness of percutaneous adhesiolysis and spinal endoscopy.
CONCLUSION
Percutaneous adhesiolysis and spinal endoscopy may be effective interventions to treat low back and lower extremity pain caused by epidural adhesions.
Topics: Animals; Clinical Trials as Topic; Endoscopy; Humans; Hyaluronoglucosaminidase; Injections, Spinal; Low Back Pain; Manipulation, Spinal; Saline Solution, Hypertonic; Sodium Chloride; Spinal Diseases; Spine; Tissue Adhesions; Treatment Outcome
PubMed: 17256027
DOI: No ID Found -
The Cochrane Database of Systematic... Mar 2018Hyaluronidase has been used over many decades as an adjunct to local anaesthetic solution to improve the speed of onset of eye blocks and to provide better akinesia and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hyaluronidase has been used over many decades as an adjunct to local anaesthetic solution to improve the speed of onset of eye blocks and to provide better akinesia and analgesia. With the evolution of modern eye surgery techniques, fast onset and akinesia are not essential requirements anymore. The assumption that the addition of hyaluronidase to local anaesthetic injections confers better analgesia for the patient needs to be examined. There has been no recent systematic review to provide evidence that hyaluronidase actually improves analgesia.
OBJECTIVES
To ascertain if adding hyaluronidase to local anaesthetic solutions for use in ophthalmic anaesthesia in adults results in a reduction of perceived pain during the operation and to assess harms, participant and surgical satisfaction, and economic impact.
SEARCH METHODS
We carried out systematic searches in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and four other databases in June 2017. We searched the trial registers at www.ISRCTN.com, ClinicalTrials.gov and www.clinicaltrialsregister.eu for relevant trials. We imposed no language restrictions.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) that evaluated the effect of hyaluronidase on pain experienced by adults during intraocular surgery using a rating scale.
DATA COLLECTION AND ANALYSIS
Two review authors (HR and KA) independently extracted data and assessed methodological quality using standard procedures as expected by Cochrane.
MAIN RESULTS
We included seven trials involving 500 participants that studied the effect of hyaluronidase on intraoperative pain. Four of the seven trials with 289 participants reported the primary outcome in a dichotomous manner, and we proceeded to meta-analyse the findings which showed a moderate heterogeneity that could not be explained (I = 41% ). The pooled risk ratio (RR) for these four trials was 0.83 with the 95% confidence interval ranging from 0.48 to 1.42. The reduction in intraoperative pain scores in the hyaluronidase group were not statistically significant. Among the three trials that reported the primary outcome in a continuous manner, the presence of missing data made it difficult to conduct a meta-analysis. To further explore the data, we imputed standard deviations for the other studies from another included RCT (Sedghipour 2012). However, this resulted in substantial heterogeneity between study estimates (I² = 76% ). The lack of reported relevant data in two of the three remaining trials made it difficult to assess the direction of effect in a clinical setting.Overall, there was no statistical difference regarding the intraoperative reduction of pain scores between the hyaluronidase and control group. All seven included trials had a low risk of bias.According to GRADE, we found the quality of evidence was low and downgraded the trials for serious risk of inconsistency and imprecision. Therefore, the results should be analysed with caution.Participant satisfaction scores were significantly higher in the hyaluronidase group in two high quality trials with 122 participants. Surgical satisfaction was also superior in two of three high quality trials involving 141 participants. According to GRADE, the quality of evidence was moderate for participant and surgical satisfaction as the trials were downgraded for imprecision due to the small sample sizes. The risk of bias in these trials was low.There was no reported harm due to the addition of hyaluronidase in any of the studies. No study reported on the cost of hyaluronidase in the context of eye surgery.
AUTHORS' CONCLUSIONS
The effects of adding hyaluronidase to local anaesthetic fluid on pain outcomes in people undergoing eye surgery are uncertain due to the low quality of evidence available. A well designed RCT is required to address inconsistency and imprecision among the studies and to determine the benefit of hyaluronidase to improve analgesia during eye surgery. Participant and surgical satisfaction is higher with hyaluronidase compared to the control groups, as demonstrated in moderate quality studies. There was no harm attributed to the use of hyaluronidase in any of the studies. Considering that harm was only rarely defined as an outcome measure, and the overall small number of participants, conclusions cannot be drawn about the incidence of harmful effects of hyaluronidase. None of the studies undertook cost calculations with regards to use of hyaluronidase in local anaesthetic eye blocks.
Topics: Adult; Analgesia; Analgesics; Anesthesia, Local; Anesthetics, Local; Humans; Hyaluronoglucosaminidase; Intraoperative Complications; Pain Measurement; Pain, Procedural; Patient Satisfaction; Randomized Controlled Trials as Topic
PubMed: 29498413
DOI: 10.1002/14651858.CD010368.pub2 -
The Cochrane Database of Systematic... Apr 2006Dilatation and effacement of the cervix are not only a result of uterine contractions, but are also dependent upon ripening processes within the cervix. The cervix is a... (Review)
Review
BACKGROUND
Dilatation and effacement of the cervix are not only a result of uterine contractions, but are also dependent upon ripening processes within the cervix. The cervix is a fibrous organ composed principally of hyaluronic acid, collagen and proteoglycan. Hyaluronic acid increases markedly after the onset of labour. An increase in the level of hyaluronic acid is associated with an increase in tissue water content. Cervical ripening during labour is characterised by changes of the cervix and an increased water content. Cervical injection of hyaluronidase was postulated to increase cervical ripening. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology.
OBJECTIVES
To determine the effects of hyaluronidase for third trimester cervical ripening or induction of labour in comparison with other methods of induction of labour.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group Trials Register (January 2006) and bibliographies of relevant papers.
SELECTION CRITERIA
Clinical trials of hyaluronidase for third trimester cervical ripening or labour induction.
DATA COLLECTION AND ANALYSIS
A strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. We assessed trial quality. We contacted study authors for additional information. We collected adverse effects information from the trials.
MAIN RESULTS
One trial, with 168 women participating, was included in the review. When compared with placebo for cervical ripening intracervical injections of hyaluronidase resulted in women receiving significantly fewer caesarean sections (18% versus 49%, relative risk (RR) 0.37, 95% confidence interval (CI) 0.22 to 0.61), less need for oxytocin augmentation (10% versus 47%, RR 0.20, 95% CI 0.10 to 0.41), and increased cervical favourability after 24 hours (60% versus 98%, RR 0.62, 95% CI 0.52 to 0.74). No side-effects for mother or baby were reported in this trial.
AUTHORS' CONCLUSIONS
Intracervical injections of hyaluronidase for cervical ripening appear beneficial. However, this is not common practice. In addition it is an invasive procedure that women may find unacceptable in the presence of less invasive methods.
Topics: Cervical Ripening; Female; Humans; Hyaluronoglucosaminidase; Labor, Induced; Oxytocics; Pregnancy
PubMed: 16625569
DOI: 10.1002/14651858.CD003097.pub2