Effectiveness of a Single Dose of Oral Vs Rectal Paracetamol in Reducing Fever in Children Aged Between 2 to 6 years – A Randomized Controlled Trial

2020 ◽  
Author(s):  
Nalaka Imbulana ◽  
LakKumar Fernando
Keyword(s):  
Single Dose ◽  
Data Extraction ◽  
Controlled Trial ◽  
District General Hospital ◽  
Oral Route ◽  
Axillary Temperature ◽  
Local Setting ◽  
Rectal Route ◽  
Significant Difference ◽  
Oral Group

Abstract Background: Rectal route of paracetamol is preferred to the commonly used oral route in some instances. Yet there is no previous documented study comparing the two routes in the local setting.Methods: Single-centre, balanced randomized [1:1], two arms, parallel-group clinical trial was conducted in single Paediatric ward at the Gampaha District General Hospital, Sri Lanka. Children aged between 2-6 years with documented axillary temperature > 100° F were enrolled. Children were randomly divided into two arms with 135 participants in each arm. The first arm received single doses of 15 mg/kg oral paracetamol and second group received single doses of 30 mg/kg rectal paracetamol. A data extraction sheet was to record temperature at baseline and at 15 minutes, 30 minutes, 1 hour, 1 and1/2 hours, 2 hours, 2 and ½ hours and 3 hours after administration of the drug. The rate of temperature (time taken fever reduction by at least 1 F) reduction was calculated in 270 sample. In addition, the potential adverse events of the both groups were recorded. Results: In the oral group, mean temperature reductions at 15 minutes, 30 minutes, 1 hour, 1 and1/2 hours, 2 hours, 2 and ½ hours and 3 hours after administration of the drug were 0.11, 0.44, 1.06, 1.68, 2.10, 3.18 and 2.75 0F respectively. The respective temperature reductions in rectal group were 0.26, 0.67, 1.31, 3.52, 2.81, 3.33 and 4.45 0F. When compared the means of both groups there was statistically significant difference between two groups in all the time periods (P<0.05) except at 1 hour after administration of paracetamol (P = 0.06). There was no statistical significant difference in side effects when comparing two arms as well. Conclusion: A single dose of 30 mg/kg rectal paracetamol is more effective than single dose of 15 mg/kg oral paracetamol in reducing fever. There is no difference in relation to the safety of the two routes.Trial registration: SLCTR, SLCTR/2017/025. Registered 17 August 2017-Retrospectively registered,

scholarly journals Effectiveness of Antipyretic with Tepid Sponging Versus Antipyretic Alone in Febrile Children: A Randomized Controlled Trial

2018 ◽  
Vol 37 (2) ◽  
pp. 129-133
Author(s):  
Chetak Kadbasal Basavaraj ◽  
Shyamala Gowri Pocha ◽  
Ravi Mandyam Dhati
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Study Group ◽  
Axillary Temperature ◽  
Medical College ◽  
Randomized Controlled ◽  
Significant Difference

Introduction: Fever is the most common presenting complain for which children are brought to the paediatrician.Physical methods are widely used in treating febrile children, tepid sponging being commonly practiced in hospitals along with antipyretics. The objectives of this study were to compare the effectiveness of tepid sponging and antipyretic drug versus antipyretic drug alone in febrile children.Material and Methods: This was a Randomized controlled trial done in JSS Medical College and Hospital. All children under the age of 6 months to 12 years, admitted with axillary temperature of >99oF were included in the study. A total of 500 children were included over two years study period. Children with recorded axillary temperature of >990F were randomized into control and study group by computer generated randomisation. Children in the control group received only paracetamol (15mg/kg) at 5 minutes and combined group received paracetamol and tepid sponging at five minutes. Axillary temperature was monitored every 15 minutes for a period of 2 hours in both the groups.Results: There is no significant difference in reduction of temperature between the two groups by the end of two hours. Children in combined group had a higher level of discomfort than those in only antipyretic group.Conclusion: Tepid sponging does not add to the efficacy of paracetamol in antipyresis and that addition of tepid sponging to antipyretic, results in additional discomfort for the child. This study, therefore, endorses the view that antipyretic alone without tepid sponging should be the modality of therapy in children with fever.  

THE STUDY OF SUBLINGUAL, ORALAND VAGINALADMINISTRATION OF MISOPROSTOL IN REGRESSION OF SYMPTOMS OF MISSED ABORTION

2021 ◽  
pp. 79-82
Author(s):  
Palash Kanti Kundu ◽  
Sandip Ghosh ◽  
Debarshi Jana
Keyword(s):  
Controlled Trial ◽  
Oral Route ◽  
Success Rates ◽  
Missed Abortion ◽  
Medical College ◽  
Randomized Controlled ◽  
Obstetrics And Gynaecology ◽  
Sublingual Misoprostol ◽  
Prospective Sampling ◽  
Oral Group

Background: Misoprostol is a widely popularly used drug in treatment of missed abortions. It is very simple to use, easily available and has an average efciency greater than 90%. Adrug this popular and versatile needs better study to improve its efciency and minimize all possible adverse unwanted effects. Hence the idea to make a comparative study between the different modes of administration of Misoprostol was arrived upon so as to understand it in a much better way. Aim: A comparison of the efcacy of Misoprostol used in sublingual, oral and vaginal routes for missed abortion. Material and methods: The study was conducted at the Department of Obstetrics and Gynaecology in Nilratan Sircar Medical College and Hospital, Kolkata after approval by the ethical committee. The sample size was 100 women being treated for missed abortions where prospective sampling was carried out to determine the candidates to be selected for the study. Single centred, institution based, randomized controlled trial. Cases included in this study were divided into 3 groups: Sublingual Group, Oral Group and Vaginal Group. Result: It was found that in oral, 4(11.8%) patients had fever. In sublingual, 6(17.6%) patients had fever. In vaginal, 2(5.9%) patients had fever. Association of fever vs. group was not statistically signicant (p=0.3220). Conclusion: The study demonstrates that both vaginal and sublingual misoprostol have similar and higher success rates in inducing abortion compared to oral route

Oral versus Intraperitoneal Application of Clindamycin in Tunnel Infections: A Prospective, Randomized Study in Capd Patients

1997 ◽  
Vol 17 (5) ◽  
pp. 486-492 ◽  
Author(s):  
Joerg Plum ◽  
Suzan Artik ◽  
Theo Busch ◽  
Kurtulus Sahin ◽  
Bernd Grabensee
Keyword(s):  
Randomized Study ◽  
Fluid Collection ◽  
Oral Route ◽  
Study Entry ◽  
Prospective Randomized Study ◽  
Exit Site ◽  
Exit Site Infection ◽  
Significant Difference ◽  
Oral Group ◽  
Intraperitoneal Treatment

Objective To evaluate the potential superiority of either oral or intraperitoneal treatment of catheter tunnel infections (TI), using clindamycin as a first-Iine antibiotic and ultrasound as a diagnostic tool. Design This was a prospective, randomized study in continuous ambulatory peritoneal dialysis patients. From August 1993 until August 1995, 16 clinically and ultrasound-proven episodes of TI were randomly assigned to either an oral or an intraperitoneal (IP) treatment (100 patients, 1414 patient-months). Main criteria for TI diagnosis were purulent drainage from the exit site and/or a positive ultrasound (pericatheter fluid collection of at least 2 mm, 7.5 MHz transducer). Initially, clindamycin (20 mg/kg body weight) was given via the oral (three times per day) or intraperitoneal route (four times per day). In the case of incompatibility or resistance to clindamycin, either oxacillin orciprofloxacin were used orally or IP. Results Based on ultrasound criteria, the mean time until a ≥50% reduction of pericatheter abscess diameter was 26 days (median) (range: 8 28 days) in the oral, and 15 days (8 27 days) in the IP group (p ≤ 0.05). Showing no significant difference of pericatheter fluid at study entry with 4 mm (median) (range: 2 -6 mm) in the oral group and 4 mm (2 -4 mm) in the IP group, the IP treatment resulted in a decrease to 0 mm (0 2 mm) after 28 days (p < 0.05), while the diameter was still 2 mm (0 10 mm) (NS) in the oral group. Disappearance of exit-site infection was also somewhat earlier in the intraperitoneal group (51 vs 15 days, NS). Catheter removal had to be done once in the IP group and twice in the oral group within 6 months after study entry. Conclusions The results give evidence for greater efficacy of the IP application of clindamycin as a first -Iine antibiotic compared to the oral route for the treatment of tunnel infections.

A randomized controlled trial (RCT) of 2 dose ratios for conversion from parenteral to oral methadone in patients with cancer pain.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 206-206
Author(s):  
Jesus Gonzalez-Barboteo ◽  
Josep Porta-Sales ◽  
Maria Nabal-Vicuña ◽  
Leyre Diez-Porres ◽  
Jaume Canal ◽  
...  
Keyword(s):  
Side Effects ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Controlled Trial ◽  
Oral Route ◽  
Dose Ratio ◽  
Double Blind ◽  
Patients With Cancer ◽  
Significant Difference ◽  
Lower Ratio

206 Background: Methadone (M) is frequently used for severe cancer pain using the parenteral and oral route. The most commonly used dose ratio (DR) parenteral: oral is 1:2. However, methadone is highly bioavailable and a lower ratio might result in similar analgesia with less toxicity. The main objective of this RCT is to compare success and side effects with 2 ratios of parenteral to oral M: 1:2 vs 1:1.2 in hospitalized patients with cancer pain. Methods: Inpatients with cancer pain well controlled with parenteral M requiring rotation to the oral route. Double blind RCT. Outcomes included pain intensity (BPI), opioid toxicity (CTCAE), and M dose. Success was defined as good pain control with no toxicity at 72hs. Results: 39/44 randomized patients were evaluable (89%): 21 in DR 1:2 and 18 in DR 1:1.2. 71% male, median age 65. No significant difference between DR1:2 and DR1:1.2 in frequency of neuropathic pain (64 Vs 68%), Papscore A/B (100 Vs 91%), CAGE + (23 Vs 18%). Median M dose pre/post was 24.5mg±13.5 y 49 mg±27.3 for DR 1:2, Vs 23.3mg±9.4 (p: NS) y 28mg±11.3 (p < 0.01) for DR 1:1.2. The DR1:2 group developed more cumulative toxicity at dasy 1, 2 and 3 (p < 0.015, p < 0.006 y p < 0.001 respectively). Pain intensity pre/ post was: 1.58±1.3 and 0.87±1.0, ns for DR 1:2, Vs 1.13±0.7 (p:NS) and 1.07±0.9 (p:NS) for DR 1:1.2. Success was observed in 12 pts in DR1:2 Vs 18 in DR 1:1.2, p < 0.001. Side effects related to M were observed in 33/46 pts in DR 1:2 (mainly neurotoxicity symptoms) Vs 1/6 in DR 1:1.2. Conclusions: DR 1:1.2 when changing from parenteral to oral M resulted in lower toxicity and no difference in analgesia. More conservative dose adjustment during M route change should be considered. Granted by Spanish Ministry of Health EC10-133. EUDRACT Number: 2010-024092-39. Clinical trial information: 2010-024092-39.

scholarly journals Day 5 versus Day 6 blastocyst transfers: a systematic review and meta-analysis of clinical outcomes

2019 ◽  
Vol 34 (10) ◽  
pp. 1948-1964 ◽  
Author(s):  
Mathilde Bourdon ◽  
Khaled Pocate-Cheriet ◽  
Astri Finet de Bantel ◽  
Veronika Grzegorczyk-Martin ◽  
Aureli Amar Hoffet ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Outcomes ◽  
Live Birth ◽  
Data Extraction ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Random Effect ◽  
Clinical Pregnancy ◽  
Cochrane Library ◽  
Significant Difference

Abstract STUDY QUESTION Is there a difference in clinical pregnancy and live birth rates (LBRs) between blastocysts developing on Day 5 (D5) and blastocysts developing on Day 6 (D6) following fresh and frozen transfers? SUMMARY ANSWER D5 blastocyst transfers (BTs) present higher clinical pregnancy and LBRs than D6 in both fresh and frozen transfers. WHAT IS KNOWN ALREADY BT is increasingly popular in assisted reproductive technology (ART) centers today. To our knowledge, no meta-analysis has focused on clinical outcomes in both fresh and frozen BT. Concerning frozen blastocysts, one meta-analysis in 2010 found no significant difference in pregnancy outcomes between D5 and D6 BT. Since then, ART practices have evolved particularly with the wide use of vitrification, and more articles comparing D5 and D6 BT cycles have been published and described conflicting results. STUDY DESIGN, SIZE, DURATION Systematic review and meta-analysis of published controlled studies. Searches were conducted from 2005 to February 2018 on MEDLINE and Cochrane Library and from 2005 to May 2017 on EMBASE, Eudract and clinicaltrials.gov, using the following search terms: blastocyst, Day 5, Day 6, pregnancy, implantation, live birth and embryo transfer (ET). PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 47 full-text articles were preselected from 808 references, based on title and abstract and assessed utilizing the Newcastle–Ottowa Quality Assessment Scales. Study selection and data extraction were carried out by two independent reviewers according to Cochrane methods. Random-effect meta-analysis was performed on all data (overall analysis) followed by subgroup analysis (fresh, vitrified/warmed, slow frozen/thawed). MAIN RESULTS AND THE ROLE OF CHANCE Data from 29 relevant articles were extracted and integrated in the meta-analysis. Meta-analysis of the 23 studies that reported clinical pregnancy rate (CPR) as an outcome, including overall fresh and/or frozen ET cycles, showed a significantly higher CPR following D5 ET compared with D6 ET (risk ratio (RR) = 1.27, 95% CI: 1.15–1.39, P < 0.001). For CPR, calculated subgroup RRs were 2.38 (95% CI: 1.74–3.24, P < 0.001) for fresh BT; 1.27 (95% CI: 1.16–1.39, P < 0.001) for vitrified/warmed BT; and 1.15 (95% CI: 0.93–1.41, P = 0.20) for slow frozen/thawed BT. LBR was also significantly higher after D5 BT (overall RR = 1.50 (95% CI: 1.32–1.69), P < 0.001). The LBR calculated RRs for subgroups were 1.74 (95% CI: 1.37–2.20, P < 0.001) for fresh BT; 1.38 (95% CI: 1.23–1.56, P < 0.001) for vitrified/warmed BT; and 1.44 (95% CI: 0.70–2.96, P = 0.32) for slow frozen/thawed BT. Sensitivity analysis led to similar results and conclusions: CPR and LBR were significantly higher following D5 compared to D6 BT. LIMITATIONS, REASONS FOR CAUTION The validity of meta-analysis results depends mainly on the quality and the number of the published studies available. Indeed, this meta-analysis included no randomized controlled trial (RCT). Slow frozen/thawed subgroups showed substantial heterogeneity. WIDER IMPLICATIONS OF THE FINDINGS In regards to the results of this original meta-analysis, ART practitioners should preferably transfer D5 rather than D6 blastocysts in both fresh and frozen cycles. Further RCTs are needed to address the question of whether D6 embryos should be transferred in a fresh or a frozen cycle. STUDY FUNDING/COMPETING INTEREST(S) This work was sponsored by an unrestricted grant from GEDEON RICHTER France. The authors have no competing interests to declare. REGISTRATION NUMBER CRD42018080151.

scholarly journals Differences in Spatial Memory Impairment in Mice after Oral D-Galactose Administration and Intraperitoneal Injection

2020 ◽  
Vol 8 (A) ◽  
pp. 342-344
Author(s):  
Ketut Widyastuti ◽  
A. A A. Putri Laksmidewi ◽  
I Made Oka Adnyana ◽  
D. P. G. Purwa Samatra
Keyword(s):  
Spatial Memory ◽  
Intraperitoneal Injection ◽  
Memory Impairment ◽  
Oral Route ◽  
Control Group ◽  
Control Group Design ◽  
Injection Group ◽  
Significant Difference ◽  
Oral Group ◽  
Male Wistar Rats

BACKGROUND: The aging process can increase the incidence of dementia, such as spatial memory impairment to remember space, recognize shapes and distances. Research on dementia in mice was carried out by administering d-galactose through intraperitoneal injection, while oral d-galactose administration had not received enough attention. AIM: This study aims to prove the differences in the occurrence of spatial memory impairment in rats induced by d-galactose through two different routes, oral and intraperitoneal injection. METHODS: This study is an experimental study using a post- test control group design. The sample criteria were 20 male Wistar rats aged 12–14 weeks, weighing 200–300 g divided into two groups which are the oral and intraperitoneal injection. Spatial memory assessment based on spontaneous alternation using the Y-maze test was carried out at the end of week 8. RESULTS: In this study, the average spatial memory score after d-galactose administration in the injection group (51.572±4.388) was lower compared to the oral group (66.058±1.551). The Shapiro–Wilk normality test shows that the data are normally distributed with p > 0.05. Independent t-test showed a significant difference in the incidence of spatial memory disorders between the injection and oral groups with p = 0.010 (p < 0.05). CONCLUSION: The conclusion of this study is that d-galactose administration by oral route or intraperitoneal injection causes a decrease in spatial memory in mice. Spatial memory in the injection group was lower than in the oral group. This might be related to the decrease in synaptophysin in the hippocampus of mice due to d-galactose administration by intraperitoneal injection.

Initial Serological Response after Prime-boost Pneumococcal Vaccination in Rheumatoid Arthritis Patients: Results of a Randomized Controlled Trial

2017 ◽  
Vol 44 (12) ◽  
pp. 1794-1803 ◽  
Author(s):  
Mai T.T. Nguyen ◽  
Hanne Lindegaard ◽  
Oliver Hendricks ◽  
Charlotte Sværke Jørgensen ◽  
Bjørn Kantsø ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Single Dose ◽  
Primary Endpoint ◽  
Pneumococcal Vaccine ◽  
Controlled Trial ◽  
Pneumococcal Vaccination ◽  
Serological Response ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Polysaccharide Pneumococcal Vaccine

Objective.To evaluate the initial serological responses to pneumococcal vaccination with the 13-valent protein-conjugated pneumococcal vaccine (PCV13) followed by the 23-valent polysaccharide pneumococcal vaccine (PPV23) among patients with rheumatoid arthritis (RA) treated with biological disease-modifying antirheumatic drugs (bDMARD) according to dosing and intervals between immunizations.Methods.Investigator-initiated clinical trial. Patients with RA receiving bDMARD were randomized (1:1:1) to immunization with single dose PCV13 followed by PPV23 after 16 or 24 weeks, or double dose PCV13 followed by PPV23 after 16 weeks. A comparison group of patients with RA treated with conventional synthetic (cs)DMARD received single dose PCV13 followed by PPV23 16 weeks later. Pneumococcal antibodies were collected before and 4 weeks after each vaccination. The primary endpoint was the proportion of participants responding to ≥ 6/12 pneumococcal serotypes 4 weeks after both vaccinations.Results.Sixty-five participants receiving bDMARD and 35 participants receiving csDMARD were included. After PPV23 vaccination, 87% (95% CI 0.76–0.94) and 94% (95% CI 0.77–0.99), respectively, of participants treated with bDMARD and csDMARD had reached the primary endpoint. There was no significant difference in primary endpoint between the 3 randomization arms. The response for rituximab-treated participants was 25% compared to ≥ 89% in participants treated with bDMARD with other mode of action.Conclusion.The early serological response to prime-boost vaccination with PCV13 followed by PPV23 was very similar among participants receiving bDMARD and csDMARD. However, notable differences in response were observed according to individual bDMARD. It is important to consider the RA treatment when planning pneumococcal vaccination in patients with RA.

scholarly journals Comparative Evaluation of Ketoconazole 400 mg Single Dose Versus Ketoconazole 200 mg Daily for Five Days in Pityriasis Versicolor

2021 ◽  
Vol 17 (1) ◽  
pp. 69-74
Author(s):  
Harendra Kumar Jha ◽  
Tapan Kumar Dhali ◽  
Ritu Amatya
Keyword(s):  
Single Dose ◽  
Controlled Trial ◽  
Treatment Success ◽  
Pityriasis Versicolor ◽  
Mycological Cure ◽  
Chi Square ◽  
Significant Difference ◽  
Chi Square Test ◽  
Group A ◽  
Group B

Introduction: Many treatments have been attempted in pityriasis versicolor with different reports of success. No direct comparative study between Ketoconazole 400 mg single dose against Ketoconazole 200 mg od for 5 days have been made earlier. The aim of this study was to study and compare the therapeutic efficacy of oral ketoconazole 400 mg single dose with oral ketoconazole 200 mg once daily for 5 days in pityriasis versicolor. Methods: This was a randomized controlled trial. Patients were randomized to receive either ketoconazole 400 mg single dose (group A) or ketoconazole 200 mg daily for 5 days (group B). Altogether 80 patients were taken, 40 in each group. Patients were assessed after 8 weeks and both clinical and mycological evaluation was done. The treatment success (mycological cure) was defined by a negative KOH at 8 weeks post treatment. Chi-square test was used to identify the significance of the variables. Results: The mycological cure at 8 weeks was 46% in group A and 74% in group B and the result was significant. No significant adverse event was noted in any of the groups. Conclusions: There was significant difference in the treatment outcome in both the groups. Ketoconazole 200 mg daily for 5 days had superior efficacy than ketoconazole 400 mg single dose. There was no significant difference in the adverse events.   Key words: Ketoconazole, Pityriasis versicolor

scholarly journals Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon

Viruses ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 989
Author(s):  
Ali A. Samaha ◽  
Hussein Mouawia ◽  
Mirna Fawaz ◽  
Hamad Hassan ◽  
Ali Salami ◽  
...  
Keyword(s):  
Single Dose ◽  
Viral Load ◽  
Hospital Admissions ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Preventive Treatment ◽  
Control Group ◽  
Significant Difference ◽  
Clinical Benefits ◽  
Asymptomatic Subjects

Objective: This study was designed to determine the efficacy of ivermectin, an FDA-approved drug, in producing clinical benefits and decreasing the viral load of SARS-CoV-2 among asymptomatic subjects that tested positive for this virus in Lebanon. Methods: A randomized controlled trial was conducted in 100 asymptomatic Lebanese subjects that have tested positive for SARS-CoV2. Fifty patients received standard preventive treatment, mainly supplements, and the experimental group received a single dose (according to body weight) of ivermectin, in addition to the same supplements the control group received. Results: There was no significant difference (p = 0.06) between Ct-values of the two groups before the regimen was started (day zero), indicating that subjects in both groups had similar viral loads. At 72 h after the regimen started, the increase in Ct-values was dramatically higher in the ivermectin than in the control group. In the ivermectin group, Ct increased from 15.13 ± 2.07 (day zero) to 30.14 ± 6.22 (day three; mean ± SD), compared to the control group, where the Ct values increased only from 14.20 ± 2.48 (day zero) to 18.96 ± 3.26 (day three; mean ± SD). Moreover, more subjects in the control group developed clinical symptoms. Three individuals (6%) required hospitalization, compared to the ivermectin group (0%). Conclusion: Ivermectin appears to be efficacious in providing clinical benefits in a randomized treatment of asymptomatic SARS-CoV-2-positive subjects, effectively resulting in fewer symptoms, lower viral load and reduced hospital admissions. However, larger-scale trials are warranted for this conclusion to be further cemented.

scholarly journals Preemptive analgesic effectiveness of single dose intravenous ibuprofen in infants undergoing cleft palate repair: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhe Zhe Peng ◽  
Yan Ting Wang ◽  
Ma Zhong Zhang ◽  
Ji Jian Zheng ◽  
Jie Hu ◽  
...  
Keyword(s):  
Single Dose ◽  
Adverse Events ◽  
Cleft Palate ◽  
Controlled Trial ◽  
Postanesthesia Care Unit ◽  
Rescue Analgesia ◽  
Significant Difference ◽  
Cleft Palate Repair ◽  
Palate Repair ◽  
Intravenous Ibuprofen

Abstract Background Correction surgery for cleft palate is recommended between 9 and 18 months of age. Patients suffer from acute pain after palatoplasty. Clinicians are hesitant to use opioids for analgesia concerning the potential high risk of respiratory adverse events. Intravenous ibuprofen perhaps be a suitable adjuvant to pain relief. We try to assess whether preoperative administration of intravenous ibuprofen can decrease opioid requirements following cleft palate repair in infants. Methods This single center prospective randomized clinical trial was performed from February to April 2021 at Department of Anesthesiology in Shanghai Children’s Medical Center. Forty patients ASA I-II, aged 9–24 months with isolated cleft palate and undergoing palatoplasty were randomized in a 1:1 ratio to receive either a single dose of 10 mg/kg ibuprofen intravenously or normal saline at induction. Children and infants postoperative pain scale (CHIPPS) was used for pain assessment. Those patients CHIPPS pain score equal or higher than 4 received analgesic rescue with titrating intravenous fentanyl 0.5 μg/kg and repeated in 10 min if required. The primary outcome was the amount of postoperative fentanyl used for rescue analgesia in postanesthesia care unit (PACU). Results Patients (n = 20 in each group) in IV-Ibuprofen group required less postoperative fentanyl than those in placebo group (p<0.001). There was no significant difference between two groups in first rescue analgesia time (p = 0.079) and surgical blood loss (p = 0.194). No incidence of obvious adverse events had been found within the first 24 h after surgery in both groups. Conclusions Preemptive intravenous administration ibuprofen 10 mg/kg at induction had a significant opioid sparing effect in early postoperative period without obvious adverse effects in infants undergoing palatoplasty. Trial registration CHICTR, CTR2100043718, 27/02/2021 http://www.chictr.org.cn/showproj.aspx?proj=122187

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