BACKGROUND: Administration of oral sucrose or glucose with and without non-nutritive sucking is frequently used as a non-pharmacological intervention for needle-related procedural pain relief in infants. OBJECTIVES: To determine the effectiveness of sweet-tasting solutions for needle-related procedural pain in infants one month to one year of age compared with no treatment, placebo, other sweet-tasting solutions, or pharmacological or other non-pharmacological pain-relieving methods. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012); MEDLINE via Ovid (1966 to 2012); CINAHL via OVID (1982 to 2012). The World Health Organization International Clinical Trials Registry Platform was also searched for any ongoing trials. Clinical trial registries, conference proceedings and references for randomised controlled trials (RCTs) were also searched. An updated search was run to capture any new publications before finalising the review in April 2012 and no new included studies were identified. Two review authors (MK & JF) independently abstracted data and assessed quality using a standard form. Authors have been contacted for missing data. SELECTION CRITERIA: Randomised-controlled trials using a sweet-tasting solution to treat pain in healthy term infants (gestational age 37 weeks and over), between one month and 12 months of age who required needle-related procedures. These procedures included but were not limited to: subcutaneous or intramuscular injections, venepuncture, and heel lance. Studies in which the painful procedure was circumcision, lumbar puncture or supra-pubic bladder aspiration were not included as they are more severe and painful than needle-related procedures. Control conditions included no treatment or placebo (water) or any other identical intervention (same appearance and consistency) without active ingredient, another sweet-tasting solution, a pharmacological pain-relieving method (e.g. paracetamol, topical anaesthetic cream), non-pharmacological pain-relieving method (e.g. distraction method, non-nutritive sucking). DATA COLLECTION AND ANALYSIS: Assessment of trial quality, data extraction and synthesis of data were performed using standard methods of the Cochrane Pain, Palliative and Supportive Care Group. We report mean differences (MD) with 95% confidence intervals (CI) using fixed-effect models as appropriate for continuous outcome measures. We planned to report risk ratio (RR) and risk difference (RD) for dichotomous outcomes. The Chi(2) test and I(2) statistic were used to assess between-study heterogeneity. MAIN RESULTS: Sixty-five (65) studies were identified for possible inclusion in this review. Fourteen published RCTs with a total of 1551 participants met the inclusion criteria. Duration of cry was significantly reduced in infants who were administered a sweet-tasting solution [MD -13.47 (95% CI -16.80 to -10.15)], P < 0.00001 compared with water. However, there was considerable heterogeneity between the studies (I(2) = 94%) that we were unable to explain. Meta-analysis was not able to be undertaken for any of the other outcome measures, except for cry duration, because of differences in study design. However, most of the individual studies that measured pain found sucrose to significantly reduce pain compared with the control group. One study compared sucrose and Lidocaine-prilocaine cream and no significant difference was found between the two treatments for the outcomes pain and cry duration. Due to the differences between the studies, we were unable to identify the optimal concentration, volume or method of administration of sweet-tasting solutions in infants aged one to 12 months. Further large RCTs are needed. AUTHORS' CONCLUSIONS: There is insufficient evidence to confidently judge the effectiveness of sweet-tasting solutions in reducing needle-related pain in infants (one month to 12 months of age). The treatments do, however, appear promising. Data from a series of individual trials are promising, as are the results from a subset meta-analysis of studies measuring duration of crying. Further well controlled RCTs are warranted in this population to determine the optimal concentration, volume, method of administration, and possible adverse effects.
BACKGROUND: Administration of oral sucrose or glucose with and without non-nutritive sucking is frequently used as a non-pharmacological intervention for needle-related procedural pain relief in infants. OBJECTIVES: To determine the effectiveness of sweet-tasting solutions for needle-related procedural pain in infants one month to one year of age compared with no treatment, placebo, other sweet-tasting solutions, or pharmacological or other non-pharmacological pain-relieving methods. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012); MEDLINE via Ovid (1966 to 2012); CINAHL via OVID (1982 to 2012). The World Health Organization International Clinical Trials Registry Platform was also searched for any ongoing trials. Clinical trial registries, conference proceedings and references for randomised controlled trials (RCTs) were also searched. An updated search was run to capture any new publications before finalising the review in April 2012 and no new included studies were identified. Two review authors (MK & JF) independently abstracted data and assessed quality using a standard form. Authors have been contacted for missing data. SELECTION CRITERIA: Randomised-controlled trials using a sweet-tasting solution to treat pain in healthy term infants (gestational age 37 weeks and over), between one month and 12 months of age who required needle-related procedures. These procedures included but were not limited to: subcutaneous or intramuscular injections, venepuncture, and heel lance. Studies in which the painful procedure was circumcision, lumbar puncture or supra-pubic bladder aspiration were not included as they are more severe and painful than needle-related procedures. Control conditions included no treatment or placebo (water) or any other identical intervention (same appearance and consistency) without active ingredient, another sweet-tasting solution, a pharmacological pain-relieving method (e.g. paracetamol, topical anaesthetic cream), non-pharmacological pain-relieving method (e.g. distraction method, non-nutritive sucking). DATA COLLECTION AND ANALYSIS: Assessment of trial quality, data extraction and synthesis of data were performed using standard methods of the Cochrane Pain, Palliative and Supportive Care Group. We report mean differences (MD) with 95% confidence intervals (CI) using fixed-effect models as appropriate for continuous outcome measures. We planned to report risk ratio (RR) and risk difference (RD) for dichotomous outcomes. The Chi(2) test and I(2) statistic were used to assess between-study heterogeneity. MAIN RESULTS: Sixty-five (65) studies were identified for possible inclusion in this review. Fourteen published RCTs with a total of 1551 participants met the inclusion criteria. Duration of cry was significantly reduced in infants who were administered a sweet-tasting solution [MD -13.47 (95% CI -16.80 to -10.15)], P < 0.00001 compared with water. However, there was considerable heterogeneity between the studies (I(2) = 94%) that we were unable to explain. Meta-analysis was not able to be undertaken for any of the other outcome measures, except for cry duration, because of differences in study design. However, most of the individual studies that measured pain found sucrose to significantly reduce pain compared with the control group. One study compared sucrose and Lidocaine-prilocaine cream and no significant difference was found between the two treatments for the outcomes pain and cry duration. Due to the differences between the studies, we were unable to identify the optimal concentration, volume or method of administration of sweet-tasting solutions in infants aged one to 12 months. Further large RCTs are needed. AUTHORS' CONCLUSIONS: There is insufficient evidence to confidently judge the effectiveness of sweet-tasting solutions in reducing needle-related pain in infants (one month to 12 months of age). The treatments do, however, appear promising. Data from a series of individual trials are promising, as are the results from a subset meta-analysis of studies measuring duration of crying. Further well controlled RCTs are warranted in this population to determine the optimal concentration, volume, method of administration, and possible adverse effects.
Authors: Paul V Beirne; Sarah Hennessy; Sharon L Cadogan; Frances Shiely; Tony Fitzgerald; Fiona MacLeod Journal: Cochrane Database Syst Rev Date: 2018-08-09