scholarly journals LO037: A randomized double-blind trial comparing the effect on pain of an oral sucrose solution versus placebo in children 1 to 3 months old needing urethral catheterization

CJEM ◽  
2016 ◽  
Vol 18 (S1) ◽  
pp. S42-S43
Author(s):  
M. Desjardins ◽  
S. Gouin ◽  
N. Gaucher ◽  
D. Lebel ◽  
J. Gravel

Introduction: Oral sweet solutions have been accepted as effective analgesics for procedures in the neonatal population. However, there have been a limited number of trials in older infants. These studies have conflicting results. The objective of the study was to compare the efficacy of an oral sucrose solution versus placebo in reducing pain during urethral catheterization in infants 1 to 3 months old in the Emergency Department (ED). Methods: A randomized, double-blind clinical trial was conducted in a pediatric university-affiliated hospital ED. Infants, 1 to 3 months of age, were recruited and randomly allocated to receive 2 ml of 88% sucrose solution (SUC) or 2 ml of placebo solution (PLA) orally, 2 minutes before planned urethral catheterization. The primary outcome measure was the difference in pain scores as assessed by the Face, Legs, Activity, Cry and Consolability (FLACC) Pain Scale at 1 min post procedure. Secondary outcome measures were the difference in pain scores using the Neonatal Infant Pain Scale (NIPS), crying time and variations in heart rate. Results: Seventy-six participants were recruited and completed the study, 37 (group SUC) and 39 (group PLA) respectively. The mean difference in FLACC scores compared to baseline was 5.62 ± 1.32 (SUC) vs. 6.21 ± 1.15 (PLA) (p=.51) during catheterization, 2.70 ± 1.21 (SUC) vs. 2.26 ± 1.41 (PLA) at 1 min (p=.64) and 0.66 ± 1.32 (SUC) vs. 1.26 ± 1.00 (PLA) at 3 mins (p=.38). For the NIPS scores, it was 4.27 ± 1.06 (SUC) vs. 4.69 ± 0.92 (PLA) (p=.56) during procedure, 2.05 ± 0.91 (SUC) vs. 1.97 ± 1.19 (PLA) (p=.92) at 1 min and 0.49 ± 0.89 (SUC) vs. 0.89 ± 0.97 (PLA) (p=.54) at 3 mins. The difference in the mean crying time was not different between both groups: 99 ± 34 secs (SUC) vs. 100 ± 25 (PLA) (p=.99). No significant difference was found in participants’ heart rate variations during procedure 23 ± 8 BPM (SUC) vs. 26 ± 7 (PLA) (p=.60), after 1 min 19 ± 12 BPM (SUC) vs. 17 ± 7 (PLA) (p=.76) and after 3 mins -1 ± 12 BPM (SUC) vs. 3 ± 6 (PLA) (p=.53). Conclusion: In infants 1 to 3 months of age undergoing urethral catheterization in the ED, administration of an oral sweet solution did not statistically decrease pain scores as measured by the FLACC and NIPS scales. Participants’ heart rate variations and crying time were not significantly decreased when sucrose was provided.

CJEM ◽  
2017 ◽  
Vol 19 (S1) ◽  
pp. S73
Author(s):  
L. Alix-Séguin ◽  
M. Desjardins ◽  
N. Gaucher ◽  
D. Lebel ◽  
J. Gravel ◽  
...  

Introduction: Oral sweet solutions have been accepted as effective pain reducing agents for neonates. However studies in the Emergency Department (ED) setting have conflicting results. The objective is to compare the efficacy of an oral sucrose solution versus placebo in reducing pain in children 1 to 3 months of age during nasopharyngeal aspiration (NPA) in the ED. Methods: A randomized, double-blinded, placebo controlled clinical trial was conducted in a pediatric university-affiliated hospital ED. Participants from 1 to 3 months of age requiring NPA were recruited and randomly allocated to receive 2 mls of an 88% sucrose solution (SUC) or 2 mls of a placebo solution (PLA) orally, 2 mins before NPA. The primary outcome was the mean difference in pain scores at 1 min post NPA as assessed by the Face, Legs, Activity, Cry and Consolability (FLACC) Pain Scale. Secondary outcomes were the difference in pain scores using the Neonatal Infant Pain Scale (NIPS), crying time, heart rate and adverse events. Results: 72 participants were recruited and completed the study, 37 (group SUC) and 35 (group PLA) respectively. Both groups had similar demographic and clinical characteristics and baseline FLACC and NIPS pain scores (all p=value >0.4). The mean difference in FLACC scores compared to baseline was 3.3 (2.5-4.1) (SUC) vs. 3.2 (2.3-4.1) (PLA) (p=.94) at 1 min and -1.2 (-1.7 to 0.7) (SUC) vs. -0.8 (-1.5 to -0.1) (PLA) (p=.66) at 3 mins after NPA. For the NIPS scores, it was 2.3 (1.6-3.0) (SUC) vs. 2.5 (1.8-3.2) (PLA) (p=.86) at 1 min and -1.2 (-1.6 to -0.8) (SUC) vs. -0.8 (-1.3 to 0.2) (PLA) (p=.59) 3 mins after NPA. There was no difference in the mean crying time, 114 (98-130) secs (SUC) vs. 109 (92-126) secs (PLA) (p=.81). No significant difference was found in participants’ heart rate at 1 min 174 (154-194) BPM (SUC) vs. 179 (160-198) BPM (PLA) (p=.32) and at 3 mins 165 (143-187) BPM (SUC) vs. 164 (142-186) BPM (PLA) (p=.86) after NPA. Three patients had vomiting during the procedure (2 PLA and 1 SUC), and one had an episode of chocking (PLA). Conclusion: In infants 1 to 3 months of age undergoing nasopharyngeal aspiration in the ED, administration of an oral sweet solution did not statistically decrease pain scores as measured by the FLACC and NIPS scales. Participants’ heart rate and crying time were not significantly decreased when sucrose was provided.


2011 ◽  
Vol 56 (4) ◽  
pp. 210-213 ◽  
Author(s):  
F Hendry ◽  
M R Checketts ◽  
G A Mcleod

Intravenous cannulation is a commonly performed procedure. This study aimed to determine whether the success rate and pain of intravenous cannulation is affected by prior injection of intradermal lidocaine. Intravenous cannulation was performed twice in 45 healthy volunteers. Intradermal lidocaine was administered prior to one of these cannulations. The outcome measures were success or failure of cannulation, and pain of cannulation, measured with a 100 mm visual analogue pain scale. The success rate of intravenous cannulation with and without prior intradermal lidocaine was 54% and 76%, respectively. The difference was 22.0% (95% CI 1.5-27.8%; P = 0.03). Log-linear analysis for three-way interaction between the variables (outcome, vascular condition and use of lidocaine) showed a significant influence of vascular condition on outcome ( G 2 24.6, P < 0.001). The mean (SD) pain scores in the control and intervention group were 34.8 (21.0) and 13.6 (13.2) mm, respectively. The difference between the mean pain scores was 21.2 mm (95% CI 15.1-27.3 mm). In conclusion, the success rate of intravenous cannulation may be reduced with the use of intradermal lidocaine, but success rate is primarily dependent on vascular condition. Intradermal lidocaine achieves a clinically significant reduction in the pain of intravenous cannulation.


2019 ◽  
Vol 22 (10) ◽  
pp. 916-921
Author(s):  
Wanda J Gordon-Evans ◽  
Hanah Y Suh ◽  
Alonso G Guedes

Objectives Recently, a bupivacaine liposome injectable suspension (BLIS) became commercially available in the veterinary market that may provide local analgesia for 72 h. The purpose of this study was to compare a BLIS incisional block with a control protocol in cats after ovariohysterectomy (OHE). The hypothesis was that a BLIS block would provide equivalent pain relief. Methods This study was designed as a randomized, double-blind, non-inferiority trial. Students performed an OHE followed by a two-layer incisional and body wall block with either standard bupivacaine (control) or BLIS. Postoperatively, cats in the control group received robenacoxib, whereas the BLIS cats received saline. All cats were evaluated using the feline Glasgow Composite Measure Pain Scale (GCMPS) at multiple time points postoperatively. Results There were 24 control cats and 23 BLIS cats. One cat from each group required rescue medication. The mean GCMPS scores were low and the groups were equivalent at all time points ( P <0.05). This study showed that BLIS was equivalent to the control group up to 42 h and pain scores remained low up to 68 h after surgery. Conclusions and relevance BLIS incisional block is equivalent to a control pain protocol and reduces the need for continued postoperative drug administration.


2001 ◽  
Vol 6 (1) ◽  
pp. 15-25 ◽  
Author(s):  
Harald Walach ◽  
Stefan Schmidt ◽  
Yvonne-Michelle Bihr ◽  
Susanne Wiesch

We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” were significantly less likely to believe the experimental instruction, and that mostly if they had been instructed to receive coffee. Contrary to the literature we could not show an effect of instruction, but there was an effect of experimenters. It is likely, however, that these experimenter effects were not due to experimental manipulations, but to the difference in personalities.


2021 ◽  
Vol 9 (2) ◽  
pp. 3780-3784
Author(s):  
P.Vani ◽  
◽  
Sharan B Singh M ◽  

Introduction: Cigarette smoking is a prime risk factor for cardiovascular morbidity and mortality. Chronic smoking results in autonomic dysfunction leading to increased cardiovascular risk in smokers. The present study was planned to study the effect of smoking on the Cardiovascular Autonomic Functions among smokers. Materials and Methods: Fifty male subjects who were in the age group of 25 to 45 years. They were grouped into 25 smokers and 25 non-smokers. The participant subjects were selected among the staff members, residents and the patients from the routine OPD in SVIMS. Prior to study, they were informed about the procedure and the purpose of the study tests and written consents were obtained from them. The Cardiovascular Autonomic Function Tests were assessed by using a POLYGRAPH which was available in the department. Results and Conclusion: After applying the ‘t’-test for the difference between the two sample means, it was observed that there was a highly significant difference between the mean values of the BMI(i.e.p<0.01) and the para-sympathetic function tests among the smokers and the non – smokers(i.e.p<0.00). The Resting Heart Rate had significantly increased and the Deep breathing difference, the postural tachycardial index (Response to standing) and the Valsalva Ratio had significantly decreased in the smokers as compared to those in the non – smokers. After applying the ‘t’-test for the difference between the two sample means, it was observed that there was no significant difference between the mean values of the Postural hypotension test (i.e. p>0.05) and that there was a highly significant difference between the mean values of the Sustained handgrip test in the smokers and the non – smokers (i.e. p<0.00). KEY WORDS: Cardiovascular autonomic function tests, Smoking, Resting heart rate.


2021 ◽  
Vol 61 (2) ◽  
pp. 69-73
Author(s):  
Nessie Amelia Ramli ◽  
Afifa Ramadanti ◽  
Indrayady Indrayady ◽  
Yuli Doris Memy

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.


2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Isra Karaduman ◽  
Derya Karasu ◽  
Canan Yilmaz ◽  
Sedat Oner ◽  
Hilal Erdem Solak ◽  
...  

Objective. We aimed to investigate the effect of peritubal local anesthetic and opioid infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Material and Methods. Patients aged between 18 and 65 years and ASA I-III were included in this double-blind, randomized study. The patients were divided into two groups. All patients underwent spinoepidural anesthesia. 20 mL of 0.25 percent bupivacaine + 5 mg morphine (0.5 mL), in Group P (n=66), infiltrated the renal capsule, perinephric fat, muscles, subcutaneous tissue, and skin under fluoroscopy. In Group C (n=64), none of the patients received a peritubal injection. In the first 24 h pain scores, time of the first analgesic demand, the mean number of analgesic demands, and postoperative complications were compared between groups. Results. The mean VAS score at postoperative 8, 12, and 24 h and dynamic VAS score at postoperative 4, 8, 12, and 24 h were significantly lower in Group P. VAS score at postoperative 4 h was not significant. Time of the first analgesic demand was significantly longer in Group P. Conclusion. Our study results suggest that peritubal infiltration of bupivacaine with morphine after percutaneous nephrolithotomy is an effective method for postoperative pain control and reduces analgesic consumption.


Author(s):  
Dhanasekar V. M. ◽  
Sathish Rajamani ◽  
Anu C. Vijay

Evidence shows that neonates feel pain. Treating pain of infants at the time of immunizations has become a crucial part of infant care. Pharmacological treatments are rarely used during procedures because of concerns about their effectiveness3 and potential adverse effects. Therefore, non-pharmacological interventions are valuable alternatives. Use of sucrose in preterm neonates has been advocated uniformly for pain relief. The present study had taken with the aim to assess the effectiveness of oral sucrose on level of pain during DPT immunizations among infants. Study design was quasi experimental method. Sample size of the study was 60 infants who were receiving DPT immunizations at Salem Poly Clinic. Data were collected from the subjects through Modified REILY pain assessment scale. Data analysis was done through descriptive and inferential statistics. Results of the study revealed the mean level of pain for experimental group 8.03+0.91 (53.53%) where as in control group it was 11.53+1.17 (77.53%) the difference in mean percentage was 24, which indicates decreased level of pain in experimental group than in control group. The researcher concluded that giving oral sucrose during the time of vaccination in infants acts as an effective non – pharmacological measure for pain management.


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