Introduction: Most of the headache cases only require pain management in emergency department (ED). The present study aimed to evaluate the efficacy of intranasal lidocaine in this regard. Method: In this clinical trial, adult patients with primary headache were randomly treated with 7.5 mg intravenous (IV) chlorpromazine and 1 ml intranasal lidocaine 2% (treatment) or normal saline 0.9% (placebo), and were compared 5, 15, and 30 minutes later regarding success rate using SPSS 21. Result: 100 patients were assigned to either treatment or placebo group. Number needed to treat of intranasal lidocaine at 5, 15, and 30 minutes were 4 (95% CI: 2.2 – 6.6), 3 (95% CI: 1.7 – 3.5), and 4 (95% CI: 2.3 – 15.9), respectively. These measures for absolute risk reduction were 30 (95% CI: 15.2 – 44.8), 44 (95% CI: 28.7 – 59.3), and 26 percent (95% CI: 6.3 – 44.3), respectively. Pain relapse occurred in 16% of treatment and 11% of control group within 1 hour of treatment (p = 0.402). Conclusion: It seems that, intranasal lidocaine along with IV chlorpromazine could result in more successful and faster management of primary headaches in ED.

Barzegari, Hassan

Hajimohammadi, Majid

Kadkhodazadeh, Mina

Motamed, Hassan

Ziapour, Behrad

English

Introduction: Most of the headache cases only require pain management in emergency department (ED). The present study aimed to evaluate the efficacy of intranasal lidocaine in this regard. Method: In this clinical trial, adult patients with primary headache were randomly treated with 7.5 mg intravenous (IV) chlorpromazine and 1 ml intranasal lidocaine 2% (treatment) or normal saline 0.9% (placebo), and were compared 5, 15, and 30 minutes later regarding success rate using SPSS 21. Result: 100 patients were assigned to either treatment or placebo group. Number needed to treat of intranasal lidocaine at 5, 15, and 30 minutes were 4 (95% CI: 2.2 – 6.6), 3 (95% CI: 1.7 – 3.5), and 4 (95% CI: 2.3 – 15.9), respectively. These measures for absolute risk reduction were 30 (95% CI: 15.2 – 44.8), 44 (95% CI: 28.7 – 59.3), and 26 percent (95% CI: 6.3 – 44.3), respectively. Pain relapse occurred in 16% of treatment and 11% of control group within 1 hour of treatment (p = 0.402). Conclusion: It seems that, intranasal lidocaine along with IV chlorpromazine could result in more successful and faster management of primary headaches in ED. </p

Hassan Barzegari

Hassan Motamed

Behrad Ziapour

Majid Hajimohammadi

Mina Kadkhodazadeh

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Emergency. 2017; 5 (1): e79ORIGINAL RESEARCHIntranasal Lidocaine for Primary Headache Managementin Emergency Department; a Clinical TrialHassan Barzegari1, Hassan Motamed1∗, Behrad Ziapour1, Majid Hajimohammadi1, Mina Kadkhodazadeh11. Emergency Medicine Department, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.Received: August 2017; Accepted: August 2017; Published online: 16 September 2017Abstract: Introduction: Most of the headache cases only require pain management in emergency department (ED). Thepresent study aimed to evaluate the efficacy of intranasal lidocaine in this regard. Methods: In this clinical trial,adult patients with primary headache were randomly treated with 7.5 mg intravenous (IV) chlorpromazine and1 ml intranasal lidocaine 2% (treatment) or normal saline 0.9% (placebo), and were compared 5, 15, and 30minutes later regarding success rate using SPSS 21. Results: 100 patients were assigned to either treatment orplacebo group. Number needed to treat of intranasal lidocaine at 5, 15, and 30 minutes were 4 (95% CI: 2.2 –6.6), 3 (95% CI: 1.7 – 3.5), and 4 (95% CI: 2.3 – 15.9), respectively. These measures for absolute risk reductionwere 30 (95% CI: 15.2 – 44.8), 44 (95% CI: 28.7 – 59.3), and 26 percent (95% CI: 6.3 – 44.3), respectively. Painrelapse occurred in 16% of treatment and 11% of control group within 1 hour of treatment (p = 0.402). Conclu-sion: It seems that, intranasal lidocaine along with IV chlorpromazine could result in more successful and fastermanagement of primary headaches in ED.Keywords: Pain management; tension-type Headache; administration, intranasal; lidocaine; migraine disorders© Copyright (2017) Shahid Beheshti University of Medical SciencesCite this article as: Barzegari H, Motamed H, Ziapour B, Hajimohammadi M, Kadkhodazadeh M. Intranasal Lidocaine for Primary HeadacheManagement in Emergency Department; a Clinical Trial. Emergency. 2017; 5(1): e79.1. IntroductionHeadache is a common cause of emergency depart-ment (ED) visits. Most of these patients only requiresymptomatic treatment and referral to a neurolo-gist or the patient’s family physician on an outpatient basis(1). Migraine, tension, and cluster are three types of primaryheadaches with considerable clinical overlap, which suggeststhe same pathophysiology (1).Common drugs used to treat these headaches are intra-venous (IV) and oral opioids, ergot alkaloids, antiemetic, andnon-steroidal anti-inflammatory drugs (NSAIDS) (2, 3). In-tranasal route of drug administration may be more effec-tive than other routes, with lower chance of emesis, and aquicker onset of action (3). Intranasal delivery of zolmitrip-tan, civamide, cocaine, and sumatriptan has been tried fortreatment of migraine and cluster headaches (4-7).Lawrence Robbins showed the safety of intranasal lidocaine∗Corresponding Author: Hassan Motamed; Emergency Department,Golestan Hospital, Golestan Avenue, Ahvaz, Khuzestan Province,Iran. Postal code: 6135733118 Tel/Fax: +986133743099 Email:hasan_motamed@yahoo.comas a an adjunctive medication in cluster headache control (8).Studies have reported that nasal lidocaine decreased clusterand migraine headaches within several seconds to 2 minutes(9, 10). However, Blanda and their colleagues didn’t find anyevidence that supports the mentioned issue (11).There has been limited experiences regarding primaryheadache management through intranasal medication inED. Therefore, this study aimed to evaluate the efficacy of in-tranasal lidocaine in primary headache management in ED.2. Methods2.1. Study design and settingThis randomized, double blind placebo controlled trial wasdone on patients presenting to emergency department ofGolestan Hospital, Ahwaz, Iran, from July 2012, to December2014 with primary headache (migraine, cluster or tension).The study design was approved by ethics committee of AhvazJundishapur University of Medical Sciences under the num-ber U-91159 and registered on Iranian Registry of Clinical Tri-als under this number: IRCT201212289148N2. Written in-formed consent was obtained from all patients. Researchersadhered to declaration of Helsinki protocol and confidential-This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0).Downloaded from: www.jemerg.comH. Barzegari et al. 2Figure 1: Pain severity at the baseline and 5, 15, and 30 minutes af-ter treatment in lidocaine and placebo groups based on visual ana-logue scale (VAS).ity of patients’ information.2.2. ParticipantsThe subjects were patients between 15 – 55 years old whopresented to the emergency department with complaints ofprimary headaches (migraine, cluster, or tension) accordingto the definition of International Headache Society and AdHoc Committee on Classification of Headache. Patients withsigns of secondary headaches such as fever, meningismus,trauma, unstable vital signs, and altered mental status wereexcluded. Lactating and pregnant women as well as who hadtaken analgesic medications 2 hours before referring to EDwere also excluded. Participants were randomly assigned toeither treatment or control group using simple random sam-pling method.2.3. InterventionPatients in the treatment group received 1 mL intranasal li-docaine 2% (20 mg lidocaine) and 7.5 mg intravenous (IV)chlorpromazine and those in control group received 1 mL in-tranasal normal saline 0.9% and 7.5 mg IV chlorpromazine.The lidocaine and normal saline were sprayed with the sameshape and color containers.2.4. Data gatheringA checklist that consisted of baseline characteristics (sex,age), type of primary headache, pain severity, and possiblecomplications was filled for all patients by a senior emer-gency medicine resident under supervision of an emergencymedicine physician. Visual analog scale (VAS) was used torate the pain severity at the baseline as well as 5, 15, and30 minutes after drug administration. In addition, patientswere observed for an additional 30 minutes to assess whetherthey responded to the treatment or whether their pain re-turned. Patients, in charge physicians, and data analyzerwere blinded to drugs given to each group.2.5. Outcome5, 15, and 30 minute success rates were considered as themain outcome of the study.2.6. Statistical AnalysisConsidering 95% confidence interval (CI), 80% power, andaccording to the Maizals et al. and Blanda et al. findings (11,12), the minimum sample size for each study group was cal-culated to be 50 cases. Data analysis (intention to treat anal-ysis) was performed by the statistical package for social sci-ences (SPSS) version 21. Findings were presented as mean ±standard deviation or frequency and percentage. Student ttest, ANOVA and chi square or Fisher’s exact tests were usedfor comparisons. Success was defined as an at least 3 pointsdecrease of pain severity (based on VAS) 5, 15, or 30 minutesafter treatment. P < 0.05 was considered as significant.3. Results3.1. Baseline characteristics100 patients were randomly assigned to either treatment (50cases) or control (50 cases) group (54.0% female). The meanage of treatment and control groups were 32.96 ± 8.51 and29.60 ± 8.64 years, respectively (p = 0.050). Table 1 shows thebaseline characteristics of studied patients.3.2. Pain controlThe mean pain severity of patients at the time of present-ing to emergency department and 5, 15, and 30 minutes aftertreatment are summarized in table 2 and figure 1.The success rates of two groups at 5, 15, and 30 minutes arecompared in table 3. There was not any significant correla-tion between success rate and sex (p = 0.292), age (p = 0.380),and type of headache (p = 0.489).Number needed to treat of intranasal lidocaine at 5, 15, and30 minutes were 4 (95% CI: 2.2 – 6.6), 3 (95% CI: 1.7 – 3.5), and4 (95% CI: 2.3 – 15.9), respectively. These measures for abso-lute risk reduction were 30 (95% CI: 15.2 – 44.8), 44 (95% CI:28.7 – 59.3), and 26 percent (95% CI: 6.3 – 44.3), respectively.The side effects related to treatment were not apparent in ei-ther the treatment or the control group within 30 minutes af-ter treatment. Pain relapse occurred in 16% of the treatmentand 11% of the control group during 1 hour follow up (p =0.402).4. DiscussionConsidering 30, 44, and 26 percent absolute risk reductionat 5, 15, and 30 minutes after treatment, intranasal lidocainealong with intravenous chlorpromazine could result in moreThis open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0).Downloaded from: www.jemerg.com3 Emergency. 2017; 5 (1): e79Table 1: Baseline characteristics of the two studied groupsVariableGroup n (%)P valueIntranasal lidocaine PlaceboSexMale 22 (44.0) 24 (48.0)0.688Female 28(56.0) 26 (52.0)Age (year)20 – 29.9 20 (40.0) 31 (62.0)30 – 39.9 10 (20.0) 10 (20.0) 0.038≥ 40 20 (40.0) 9 (18.0)Type of headacheMigraine 16 (32.0) 22 (44.0)Tension 11 (22.0) 18 (36.0) 0.028Cluster 23 (46.0) 10 (20.0)Table 2: Pain severity of two studied groups based on visual analogue scaleTime (minute)GroupsP valueIntranasal lidocaine PlaceboBaseline 6.15 ± 1.19 5.87 ± 1.01 0.2255 4.56 ± 1.54 5.30 ± 1.29 0.01115 3.86 ± 1.57 4.76 ± 1.09 0.00130 2.94 ± 1.63 3.94 ± 1.52 0.002Table 3: Success rate of the two studied groups 5, 15, and 30 minutes after treatmentTime (minute)Group n (%)P valueIntranasal lidocaine Placebo5 18 (36) 3 (6) < 0.000115 25 (50) 3 (6) < 0.000130 30 (60) 17 (34) 0.009successful pain management of primary headaches in ED.This study showed that patients who received intranasal li-docaine along with IV chlorpromazine significantly experi-enced higher success rate in pain control at 5, 15, and 30 min-utes after treatment.Although the two studied groups had different baseline char-acteristics, the analysis of data didn’t show any relationshipbetween age, sex, and type of primary headache with treat-ment success rate.Maizels and Geiger evaluated the efficacy of intranasal li-docaine in a double-blind controlled trial with open-labelfollow-up. They found that headache was relieved within 15min in 35.8% of patients in the treatment group, with a 20.6%relapse rate (12). Mohammadkarimi and colleagues using in-tranasal lidocaine in 90 patients with primary and secondaryheadaches found significant pain relief after 1 minute, andshowed that the level of patients’ pain did not significantlychange over the course of the study. They did not assess therelapse rates or side effects related to treatment (9). In con-trast, Blanda and colleagues found that the intranasal lido-caine did not relieve pain after 5 or 30 minutes (11).Although the experience of drug delivery through nasal mu-cosa goes back to many years ago, based on a review in 2013the present method for delivering the drug to the posterior-superior part of the nose is not that effective and this couldaffect the success rate of this method to a great extent (13).It seems that using a new method that can be applied by thepatients themselves without the need for visiting the hospi-tal should be considered more seriously. This is of great im-portance, especially for cases such as primary headaches thatare usually recurrent and distractive. Of course, there is stilla long way to go in making the use of these drugs public andrevising traditional methods.5. LimitationIn the current study, we administered intranasal 2% lidocainefor different types of headache and not just for migraine. Wefollowed patients in both the treatment and control groupsfor only a short time. We did not perform follow-up assess-ments. In addition, because our treatment group receivedlidocaine and chlorpromazine together, our study is limitedThis open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0).Downloaded from: www.jemerg.comH. Barzegari et al. 4in its assessment of pure lidocaine’s ability in pain manage-ment.6. ConclusionConsidering 30, 44, and 26 percent absolute risk reductionat 5, 15, and 30 minutes after treatment, intranasal lidocainealong with IV chlorpromazine could result in more successfuland faster management of primary headaches in ED.7. Appendix7.1. AcknowledgementsThe cooperation of Golestan Hospital, Ahvaz, staff membersis appreciated.7.2. Author contributionAll the authors meet the standard criteria of authorship basedon the recommendations of the international committee ofmedical journal editors.7.3. Funding/SupportNone.7.4. Conflict of interestNone.References1. Go S. Nontraumatic headaches in the Emergency De-partment: a systematic approach to diagnosis and con-troversies in two" big ticket" entities. Missouri medicine.2008;106(2):156-61.2. Edvinsson L. Pathophysiology of primary headaches.Current pain and headache reports. 2001;5(1):71-8.3. Rapoport AM, Bigal ME, Tepper SJ, Sheftell FD. Intranasalmedications for the treatment of migraine and clusterheadache. CNS drugs. 2004;18(10):671-85.4. Van Vliet J, Bahra A, Martin V, Ramadan N, AuroraS, Mathew N, et al. Intranasal sumatriptan in clusterheadache Randomized placebo-controlled double-blindstudy. Neurology. 2003;60(4):630-3.5. Cittadini E, May A, Straube A, Evers S, Bussone G,Goadsby PJ. Effectiveness of intranasal zolmitriptanin acute cluster headache: a randomized, placebo-controlled, double-blind crossover study. Archives ofneurology. 2006;63(11):1537-42.6. Diamond S, Freitag F, Phillips S, Bernstein J, Saper J. In-tranasal Civamide for the Acute Treatment of MigraineHeadache. Cephalalgia. 2000;20(6):597-602.7. Costa A, Pucci E, Antonaci F, Sances G, Granella F, BroichG, et al. The effect of intranasal cocaine and lidocaineon nitroglycerin-induced attacks in cluster headache.Cephalalgia. 2000;20(2):85-91.8. Robbins L. Intranasal Lidocaine for Cluster Headache.Headache: The Journal of Head and Face Pain.1995;35(2):83-4.9. Mohammadkarimi N, Jafari M, Mellat A, Kazemi E, Shi-rali A. Evaluation of efficacy of intra-nasal lidocaine forheadache relief in patients refer to emergency depart-ment. Journal of research in medical sciences: the of-ficial journal of Isfahan University of Medical Sciences.2014;19(4):331.10. Generali J, Cada DJ. Intranasal lidocaine: Migraineheadaches. Hospital Pharmacy. 2001;36(2):192-223.11. Blanda M, Rench T, Gerson LW, Weigand JV. Intranasallidocaine for the treatment of migraine headache:a randomized, controlled trial. Academic EmergencyMedicine. 2001;8(4):337-42.12. Maizels M, Geiger AM. Intranasal lidocaine for mi-graine: a randomized trial and openâĂŘlabel fol-lowâĂŘup. Headache: The Journal of Head and FacePain. 1999;39(8):543-51.13. Djupesland PG, Messina JC, Mahmoud RA. Breath Pow-ered Nasal Delivery: A New Route to Rapid HeadacheRelief. Headache: The Journal of Head and Face Pain.2013;53:72-84.This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0).Downloaded from: www.jemerg.com

Intranasal Lidocaine for Primary Headache Management in Emergency Department; a Clinical Trial

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Intranasal Lidocaine for Primary Headache Management in Emergency Department; a Clinical Trial

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